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 .
Status of the Claims
Claims 7, 12, 15-16 and 18-20 are cancelled. Claims 21-25 are newly added. Claims 1-3, 6, 8-9, 11, and 13-14 are currently amended. Claims 1-6, 8-11, 13-14, 17, and 21-25 are currently pending. Claims 1-6, 8-11, 13-14, 17, and 21-25 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/19/2026, with respect to the rejection(s) of claim(s) 1, 11, and 14 as amended under 35 U.S.C. 102(a)(1)/(a)(2) 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 Therefore, the rejection has been withdrawn.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 Kimmel, Malkowski, and Alvarez.
Applicant’s arguments regarding the previously applied 112(f) interpretations are noted, and the interpretations of the claim terms “steering element”, “control element”, “first actuation element”, and “second actuation element” is withdrawn. Examiner acknowledges that the cancellation of claim 12 obviates the prior 112(f) interpretation of “drive member”.
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 25 is 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 25 recites the limitation "the service loop" in line 1 and “the stopper” in line 2. There is insufficient antecedent basis for this limitation in the claim as currently written, since as written claim 25 depends from claim 23 (dependent in turn on claim 1), which does not introduce “a service loop” or “a stopper”. It is unclear whether claim 25 is supposed to depend instead from claim 24, which does introduce “a service loop” on line 1 (and is dependent on claim 11 which introduces “a stopper”), in which case the claim should be amended to read “The delivery system of claim 24…”, or whether claim 25 is supposed to newly introduce the limitations of “a service loop” and “a stopper”, in which claim 25 should be rewritten to properly introduce these limitations. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimmel et al (US 20160008575 A1; hereafter Kimmel) in view of Malkowski et al (US 20120310220 A1; hereafter Malkowski.
Regarding claim 1, Kimmel discloses a delivery system for delivering a medical device to a desired location, the delivery system comprising:
a handle (first and second mating portions 24/26, fig. 2a, [0061] Cover 2 of control handle 10 includes a first mating portion 24 and a second mating portion 26);
a catheter shaft (steerable sheath shaft 100, fig. 2a, [0061]) extending from a proximal end of the catheter shaft attached to the handle (see fig. 6a which shows proximal end of the catheter shaft 100 engaged with handle; [0060] Distal portion 12 includes aperture 18 through which steerable sheath shaft 100 exits) to a flexible distal end portion of the catheter shaft (deflectable tip portion 200, fig. 2a and fig. 6a, [0067]);
a steering mechanism attached to the handle for steering the flexible distal end portion of the catheter shaft, the steering mechanism comprising:
a first pair of steering elements (ends 230, 252 of each rack screw 201, 202; [0062], fig. 2) comprising a first steering element (230) and a second steering element (252);
a first control member (knob 20, fig. 2a, [0063] As seen in FIG. 2A, rotatable adjustment knob 20 includes internal threads 254 circumferentially disposed about an inner wall thereof);
a first pair of actuation elements comprising a first actuation element (first pull wire 320, fig. 2a, [0062]) and a second actuation element (second pull wire 340, fig. 2a, [0062]);
the first actuation element (320) extending from a proximal end of the first actuation element attached to the first steering element (see fig. 2a; [0062] First and second pull wires 320, 340 are routed and are operably coupled to ends 230, 252 of each rack screw 201, 202, respectively) to a distal end of the first actuation element coupled to the flexible distal end portion of the catheter shaft (100) (see fig. 5b; [0077] Pull wires 320, 340 are operably coupled at their distal end to an opening 440 in pull ring 442 positioned within lumen 300 at the deflectable tip 200 end of the steerable sheath shaft 100);
the second actuation element (340) extending from a proximal end of the second actuation element attached to the second steering element (similar to above, see fig. 2a and [0062]) to a distal end of the second actuation element coupled to the flexible distal end portion of the catheter shaft (similar to above, see fig. 5b and [0077]);
wherein actuating the first control member (20, fig. 2a) of the steering mechanism moves the first and second steering elements (ends 230, 252 of each rack screw 201, 202; see fig. 2a) in opposite directions (see fig. 2a and fig. 6a) to increase tension in one of the first and second actuation elements and to release tension in the other of the first and second actuation elements ([0080] rotation of knob 20 pulls second pull wire 340 proximally while releasing tension on first pull wire 320).
Kimmel is silent to the distal ends of the first and second actuation elements coupled to an intermediate link, ring, or vertebrae of the flexible distal end portion of the catheter shaft, and the second pair of steering elements, second control member, and second pair of actuation elements.
Malkowski, directed to an instrument having a flexible and elongated body, teaches wherein the distal ends of the first and second actuation elements coupled to an intermediate link, ring, or vertebrae (see annotated fig. 12 below) of the flexible distal end portion of the catheter shaft ([0051] The connecting members 160 associated with each actuation assembly 130 are attached to different portions of the articulable portion 110, as will be discussed further below.),
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a second pair of steering elements comprising a third steering element and a fourth steering element (see annotated fig. 12 above);
a second control member (second user control 131, fig. 4, [0054]);
a second pair of actuation elements (connecting members 160 associated with the second actuation assembly 130 of control assembly 120, see fig. 4 and annotated fig. 12 above) comprising a third actuation element and a fourth actuation element ([0055] the attached connecting members 160 will translate proximally and distally with the first and second engaging members 150, 155);
the third actuation element extending from a proximal end of the third actuation element attached to the third steering element (see fig. 5, [0042] Proximal ends 161 are shown disposed in apertures 156, 157 of the first and second engaging members 150, 155, respectively) past the intermediate link, ring, or vertebrae to a distal end of the third actuation element coupled to a distal link, ring, or vertebrae of the flexible distal end portion of the catheter shaft (see annotated fig. 12 above);
the fourth actuation element extending from a proximal end of the fourth actuation element attached to the fourth steering element (similar to third actuation element, see fig. 5 and [0042]) past the intermediate link, ring, or vertebrae to a distal end of the fourth actuation element coupled to the distal link, ring, or vertebrae of the flexible distal end portion of the catheter shaft (see annotated fig. 12 above);
wherein the first actuation element, the second actuation element, the third actuation element, and the fourth actuation element are spaced around the catheter shaft such that the first pair of actuation elements is adjacent to the second pair of actuation elements (see fig. 12 and fig. 14 which show adjacent pairs of actuation elements);
wherein actuating the second control member of the steering mechanism moves the third and fourth steering elements in opposite directions to increase tension in one of the third and fourth actuation elements and to release tension in the other of the third and fourth actuation elements ([0056] as the connecting members 160 associated with the first engagement member 150 translate proximally, the connecting members 160 associated with the second engagement member 155 translate distally, and vice-versa. Thus, a pair of axially opposing forces will be exerted on opposing surfaces of the first and second segments 111, 112 through the connecting members 160. Accordingly, the surgical access assembly 100 (FIG. 1) is configured for bi-directional articulation); and
wherein actuation of the first control member and the second control member facilitate bi-directional movement of the flexible distal end portion of the catheter shaft at two spaced apart locations of the flexible distal end portion of the catheter shaft (see fig. 12, [0058] “Forward and reverse engagement of the pair of actuation assemblies 130 allows for bi-directional articulation of the first and second segments 111, 112”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Kimmel to include a second pair of steering elements, second control member, and second pair of actuation elements as taught by Malkowski since both deal with steerable medical devices, and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B). One would further have been motivated to make the modification because having the multiple sets of pull wires anchored to different vertebrae along the length of the flexible portion of the catheter allows for more complex deflections as noted in Malkowski [0058] which may be beneficial in navigating tortuous body cavities. Additionally, the modification to include the plurality of vertebrae of Malkowski fig. 12 and the first and second pairs of actuation elements anchored to different vertebrae, as taught by Malkowski, would further have been motivated by providing multiple points of solid contact permitting predictable movement and transmission of force for complex movements.
Regarding claim 2, Kimmel modified by Malkowski discloses the delivery system of claim 1, as described above, including wherein the flexible distal end portion of the catheter shaft comprises a plurality (see Malkowski fig. 12 annotated above) of links, rings or vertebrae including the intermediate (see Malkowski fig. 12 annotated above) link, ring, or vertebrae and the distal link, ring, or vertebrae at or near a distal end of the plurality of links, rings, or vertebrae (see Malkowski fig. 12 annotated above).
Regarding claim 9, Kimmel modified by Malkowski discloses the delivery system of claim 1, as described above. Kimmel further discloses wherein the first control member (knob 20) engages the first pair of steering elements (ends 230, 252 of each rack screw 201, 202; [0062], fig. 2) via a gear mechanism ([0063] As seen in FIG. 2A, rotatable adjustment knob 20 includes internal threads 254 circumferentially disposed about an inner wall thereof. Internal threads 254 will engage the proximal threads 238 of the second rack screw 202).
Claim(s) 3, 5-6, 14, 17, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimmel modified by Malkowski, and alternatively further in view of Alvarez et al (US 20100280449 A1; hereafter Alvarez).
Regarding claim 3, Kimmel modified by Malkowski discloses the delivery system of claim 1, as described above, including wherein applying tension to the first actuation element bends the catheter shaft in a first direction (Malkowski fig. 12 and [0058] “Connecting members 160 associated with a first actuation assembly 130 (FIG. 4) may be attached to opposing surfaces in each of the first and second segments 111, 112 to effect articulation in plane X”) and applying tension to the fourth actuation element bends the catheter shaft in a second direction (Malkowski fig. 12 and [0058] “connecting members 160 associated with a second articulation assembly 130 may be attached to opposing surfaces in each of the first and second segments 111, 112 and radially spaced from the connecting members 160 of the first articulation assembly 130 to effect articulation in plane Y”),
Kimmel modified by Malkowski discloses the claim limitations except for wherein the first direction and the second direction are in or along a same plane.
It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to rearrange the second pair of actuation elements of Kimmel modified by Malkowski to be in the same lumens as the first pair of actuation elements, thereby yielding predictable results without change to inventive function. Furthermore, the new configuration would be obvious to try by beneficially because it would facilitate the formation of complex shapes in a single plane, such as an “S” or “J” shape which may be ideal for navigating certain body geometries in tortuous cavities. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and product would still provide for complex bending formations.
Alternatively, Kimmel modified by Malkowski is silent to wherein the first direction and the second direction are in or along a same plane.
Alvarez, directed to a steerable medical device with two pull rings (916-1 and 916-2, see fig. 9 and [0074]), teaches wherein the first direction and the second direction (see [0075] “The lower portion of the "S" may be obtained by operating the first pull wire (914-1) to steer the proximal portion of the elongate instrument (900) into a curvature that resembles the shape of the lower portion of the "S" shape” and “the second pull wire (914-2) may be operated to steer or bend the distal portion of the elongate instrument (900) into a curvature that resembles the upper portion of the "S" as illustrated in FIG. 9.”) are in or along a same plane (see annotated fig. 9 below).
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It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Kimmel modified by Malkowski to achieve the in-plane “S” shaped curve taught by Alvarez since all three references deal with flexible medical devices. One would have been motivated to make the modification because bending in multiple directions in the same plane allows for the predictable formation of complex in-plane configurations, as shown in fig. 9 of Alvarez, which may be beneficially in navigating tortuous body cavities and accessing specific locations within body cavities.
Regarding claim 5, Kimmel modified by Malkowski discloses the delivery system of claim 3, as described above, including wherein the first direction and the second direction are opposite directions (Examiner notes that Kimmel modified by Malkowski allows for bi-directional deflection at multiple locations in the same plane, so the first and second directions may be opposite directions.).
Alternatively, Kimmel modified by Malkowski and Alvarez discloses the delivery system of claim 3, as described above, including wherein the first direction and the second direction are opposite directions (see annotated Alvarez fig. 9 above).
Regarding claim 6, Kimmel modified by Malkowski discloses the delivery system of claim 2, as described above, including wherein in a fully bent condition, the distal end of the plurality of rings or vertebrae (see Makowski annotated fig. 12) is arranged in or along a same plane as a proximal end of the plurality of rings or vertebrae (see Malkowski fig. 12; Examiner notes that many planes could be drawn which include the line between the distal end of the plurality of vertebrae and the proximal end of the plurality of vertebrae, and thus in a fully bent condition as shown in fig. 12, the two noted points are “arranged in or along a same plane”.).
Alternatively, Kimmel modified by Malkowski is silent to wherein in a fully bent condition, the distal end of the plurality of links, rings or vertebrae is arranged in or along a same plane as a proximal end of the plurality of links, rings or vertebrae.
Alvarez, directed to an instrument having a flexible and elongated body, teaches wherein the distal end of the plurality of rings or vertebrae (see Alvarez control ring 916-2 in fig. 9) is arranged in or along a same plane as a proximal end of the plurality of rings or vertebrae (see Alvarez control ring 916-1 in fig. 9) (Examiner notes that Alvarez fig. 9 shows bending in one plane, the plane of the page.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Kimmel modified by Malkowski to achieve the in-plane “S” shaped curve taught by Alvarez since all three references deal with flexible medical devices. One would have been motivated to make the modification because bending in multiple directions in the same plane allows for the predictable formation of complex in-plane configurations, as shown in fig. 9 of Alvarez, which may be beneficially in navigating tortuous body cavities and accessing specific locations within body cavities.
Regarding claim 14, Kimmel discloses a delivery system for delivering a medical device to a desired location, the delivery system comprising:
a handle (first and second mating portions 24/26, fig. 2a, [0061] Cover 2 of control handle 10 includes a first mating portion 24 and a second mating portion 26);
a catheter shaft (steerable sheath shaft 100, fig. 2a, [0061]) extending from a proximal end of the catheter shaft attached to the handle to a flexible distal end portion of the catheter shaft (transition section 180 and deflectable tip portion 200, fig. 3, [0069]) (see fig. 2a);
a steering mechanism attached to the handle for steering the flexible distal end portion of the catheter shaft, the steering mechanism comprising:
a steering element (ends 230, 252 of each rack screw 201, 202; [0062], fig. 2);
a control member (knob 20, fig. 2a, [0063] As seen in FIG. 2A, rotatable adjustment knob 20 includes internal threads 254 circumferentially disposed about an inner wall thereof);
a first actuation element (first pull wire 320, fig. 2a, [0062]) extending from a proximal end of the first actuation element attached to the steering element (see fig. 2a; [0062] First and second pull wires 320, 340 are routed and are operably coupled to ends 230, 252 of each rack screw 201, 202, respectively) to a distal end of the first actuation element attached to the flexible distal end portion of the catheter shaft (100) (see fig. 5b; [0077] Pull wires 320, 340 are operably coupled at their distal end to an opening 440 in pull ring 442 positioned within lumen 300 at the deflectable tip 200 end of the steerable sheath shaft 100;
a second actuation element (second pull wire 340, fig. 2a, [0062]) extending from a proximal end of the second actuation element attached to the steering element (similar to above, see fig. 2a and [0062]) to a distal end of the second actuation element attached to the flexible distal end portion of the catheter shaft (similar to above, see fig. 5b and [0077]);
wherein actuating the control member (20, fig. 2a) of the steering mechanism moves the steering element (ends 230, 252 of each rack screw 201, 202; see fig. 2a) to increase tension in one of the first and second actuation elements (320/340, fig. 2a) and to release tension in the other of the first and second actuation elements ([0080] rotation of knob 20 pulls second pull wire 340 proximally while releasing tension on first pull wire 320);
wherein the flexible distal end portion (180/200) of the catheter shaft comprises a first bending portion (transition section 180, fig. 3) and a second bending portion (deflectable tip portion 200, fig. 3).
Kimmel is silent to the first bending portion configured for a first bi-directional bending at a first location of the flexible distal end portion of the catheter shaft and the second bending portion configured for a second bi-directional bending at a second location of the flexible distal end portion of the catheter shaft that is spaced apart from the first location of the flexible distal end portion of the catheter shaft; and wherein the first bi-directional bending of the first bending portion is in a same plane as the second bi-directional bending of the second bending portion.
Malkowski, directed to an instrument having a flexible and elongated body, teaches wherein the flexible distal end portion (articulable portion 110, fig. 12, [0058]) of the catheter shaft (elongate member 108 having an articulable portion 110, fig. 1, [0031]) comprises a first bending portion (first segment 111, fig. 12, [0032] Articulable portion 110 includes at least a first segment 111 and a second segment 112) configured for a first bi-directional bending at a first location (of the flexible distal end portion of the catheter shaft and a second bending portion (second segment 112, fig. 12, [0032]) configured for a second bi-directional bending at a second location of the flexible distal end portion of the catheter shaft that is spaced apart from the first location of the flexible distal end portion of the catheter shaft (see fig. 12 which shows too spaced apart bending locations; [0056] describes bi-directional bending at more than one location along the flexible portion).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Kimmel to include a second bi-directional bending at a second location as taught by Malkowski since both deal with steerable medical devices, and since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B). One would further have been motivated to make the modification because having the multiple sets of pull wires anchored to different vertebrae along the length of the flexible portion of the catheter allows for more complex deflections as noted in Malkowski [0058] which may be beneficial in navigating tortuous body cavities. Additionally, the modification to include the plurality of vertebrae of Malkowski fig. 12 and the first and second pairs of actuation elements anchored to different vertebrae, as taught by Malkowski, would further have been motivated by providing multiple points of solid contact permitting predictable movement and transmission of force for complex movements.
Kimmel modified by Malkowski is silent to wherein the first bi-directional bending of the first bending portion is in a same plane as the second bi-directional bending of the second bending portion.
It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to rearrange the second pair of actuation elements of Kimmel modified by Malkowski to be in the same lumens as the first pair of actuation elements, thereby yielding predictable results without change to inventive function. Furthermore, the new configuration would be obvious to try by beneficially because it would facilitate the formation of complex shapes in a single plane, such as an “S” or “J” shape which may be ideal for navigating certain body geometries in tortuous cavities. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and product would still provide for complex bending formations.
Alternatively, Kimmel modified by Malkowski is silent to wherein the first bi-directional bending of the first bending portion is in a same plane as the second bi-directional bending of the second bending portion.
Alvarez, directed to a steerable medical device with two pull rings (916-1 and 916-2, see fig. 9 and [0074]), teaches wherein first bending of the first bending portion is in a same plane as the second of the second bending portion (see [0075] “The lower portion of the "S" may be obtained by operating the first pull wire (914-1) to steer the proximal portion of the elongate instrument (900) into a curvature that resembles the shape of the lower portion of the "S" shape” and “the second pull wire (914-2) may be operated to steer or bend the distal portion of the elongate instrument (900) into a curvature that resembles the upper portion of the "S" as illustrated in FIG. 9.”) are in or along a same plane (see annotated fig. 9 above).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Kimmel modified by Malkowski to achieve the in-plane “S” shaped curve taught by Alvarez since all three references deal with flexible medical devices. One would have been motivated to make the modification because bending in multiple directions in the same plane allows for the predictable formation of complex in-plane configurations, as shown in fig. 9 of Alvarez, which may be beneficially in navigating tortuous body cavities and accessing specific locations within body cavities.
Regarding claim 17, Kimmel modified by Malkowski, or alternatively Kimmel modified by Malkowski and Alvarez, discloses the delivery system of claim 14, as described above. Kimmel further discloses wherein the first bending portion (180, fig. 3) has a length that is different from a length of the second bending portion (200, fig. 3) (see fig. 3 which shows that each bending portion has a different length).
Regarding claim 21, Kimmel modified by Malkowski discloses the delivery system of claim 1, as described above, including wherein the first actuation element and the second actuation element are spaced apart from one another around the catheter shaft by 180 degrees (see Kimmel fig. 5a/b, see Malkowski fig. 12 and fig. 14), the third actuation element and the fourth actuation element are spaced apart from one another around the catheter shaft by 180 degrees (see Malkowski fig. 12 and fig. 14), and wherein the first actuation element is adjacent to the third actuation element (see Malkowski annotated fig. 12 above and annotated fig. 14 below), and wherein the second actuation element is adjacent to the fourth actuation element (see Malkowski annotated fig. 12 above and annotated fig. 14 below).
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In a first alternative, Kimmel modified by Malkowski is silent to wherein the first actuation element is adjacent to the third actuation element, and wherein the second actuation element is adjacent to the fourth actuation element.
It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to rearrange the second pair of actuation elements of Kimmel modified by Malkowski to be in the same lumens as the first pair of actuation elements, thereby yielding predictable results without change to inventive function. Furthermore, the new configuration would be obvious to try by beneficially because it would facilitate the formation of complex shapes in a single plane, such as an “S” or “J” shape which may be ideal for navigating certain body geometries in tortuous cavities. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and product would still provide for complex bending formations.
In a second alternative, Kimmel modified by Malkowski is silent to wherein the first actuation element is adjacent to the third actuation element, and wherein the second actuation element is adjacent to the fourth actuation element.
Alvarez, directed to a steerable medical device with two pull rings, teaches wherein the first actuation element (pull wire 1114-1, fig. 11A, [0078]) is adjacent to the third actuation element (pull wire 1124-1, fig. 11A, [0078]), and wherein the second actuation element (pull wire 1114-2, fig. 11A, [0078]) is adjacent to the fourth actuation element (pull wire 1124-2, fig. 11A, [0078]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Kimmel modified by Malkowski to have the first and third actuation elements in one lumen and the second and fourth actuation elements in a second lumen as taught Alvarez since all three references deal with flexible medical devices. One would have been motivated to make the modification because bending in multiple directions in the same plane allows for the predictable formation of complex in-plane configurations, as shown in fig. 9 and fig. 10 of Alvarez, which may be beneficial in navigating tortuous body cavities and accessing specific locations within body cavities.
Regarding claim 22, Kimmel modified by Malkowski discloses the delivery system of claim 1, as described above, including wherein the bi-directional movement of the flexible distal end portion of the catheter shaft at the two spaced apart locations of flexible distal end portion of the catheter shaft (see Malkowski fig. 12 and [0058]).
Kimmel modified by Malkowski teaches all the claim limitations except for wherein the two spaced apart locations are in a same plane.
It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to rearrange the second pair of actuation elements of Kimmel modified by Malkowski to be in the same lumens as the first pair of actuation elements, thereby yielding predictable results without change to inventive function. Furthermore, the new configuration would be obvious to try by beneficially because it would facilitate the formation of complex shapes in a single plane, such as an “S” or “J” shape which may be ideal for navigating certain body geometries in tortuous cavities. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and product would still provide for complex bending formations.
Alternatively, Kimmel modified by Malkowski is silent to wherein the two spaced apart locations are in a same plane.
Alvarez, directed to a steerable medical device with two pull rings (916-1 and 916-2, see fig. 9 and [0074]), teaches wherein the two spaced apart locations are in a same plane (see [0075] “The lower portion of the "S" may be obtained by operating the first pull wire (914-1) to steer the proximal portion of the elongate instrument (900) into a curvature that resembles the shape of the lower portion of the "S" shape” and “the second pull wire (914-2) may be operated to steer or bend the distal portion of the elongate instrument (900) into a curvature that resembles the upper portion of the "S" as illustrated in FIG. 9.”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Kimmel modified by Malkowski to achieve the in-plane “S” shaped curve taught by Alvarez since all three references deal with flexible medical devices. One would have been motivated to make the modification because bending in multiple directions in the same plane allows for the predictable formation of complex in-plane configurations, as shown in fig. 9 of Alvarez, which may be beneficially in navigating tortuous body cavities and accessing specific locations within body cavities.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimmel modified by Malkowski as applied to claim 2 above, and alternatively further in view of Kirt et al (US 20190175869 A1; hereafter Kirt)
Regarding claim 4, Kimmel modified by Malkowski discloses the delivery system of claim 2, as described above, including wherein the plurality of links, rings, or vertebrae (movable members 114, fig. 13, [0052]) include protrusions and recesses (surface protrusions 115 and surface recesses 116, fig. 13, [0052]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to connect such that they inhibit rotation of the plurality of links, rings, or vertebrae except along a longitudinal axis of the delivery system ([0052] “adjacent movable members 114 may have varying surface protrusions 115 and surface recesses 116 such that a series of adjacent movable members 114 is configured for articulation in one direction”; see central column of vertebrae 114 in fig. 13).
Alternatively, Kimmel modified by Malkowski is silent to wherein the plurality of links, rings, or vertebrae include protrusions and recesses configured to connect such that they inhibit rotation of the plurality of links, rings, or vertebrae except along a longitudinal axis of the delivery system (although Examiner points to Malkowski figs. 12-14 and [0052] “adjacent movable members 114 may have varying surface protrusions 115 and surface recesses 116 such that a series of adjacent movable members 114 is configured for articulation in one direction”).
Kirt, in the art of steerable medical devices, teaches wherein the plurality of links, rings, or vertebrae (ring members 22, fig. 3, [0046] The tubular member 14 may include a number of ring members such as the ring members 22) include protrusions (knuckle regions 38, fig. 3, [0048]) and recesses (valley regions 40, fig. 3, [0048]) configured to connect such that they inhibit rotation of the plurality of links, rings, or vertebrae except along a longitudinal axis of the delivery system ([0049] the knuckle regions 38 may all be substantially axially aligned to allow one or more preferred bending directions to be defined in the tubular member 14 (e.g., in a direction plus or minus 90 degrees from a plane passing through all the knuckle regions 38).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Kimmel modified by Malkowski to include the plurality of links, rings, or vertebrae along the length of the deflectable region as taught by Kirt since all three references deal with steerable medical devices, and since Malkowski [0052] notes protrusions and recesses which may allow a series of adjacent links to articulate in one direction. One would have been motivated to make the modification because, as noted by Kirt [0048] this arrangement “may allow the tubular member 14 to have increased compression resistance, for example if the tubular member 14 is steered by actuation of a pull wire or otherwise subjected to compression”.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kimmel modified by Malkowski, as applied to claim 1, and alternatively further in view of Bednarek et al (US 20060142694 A1; hereafter Bednarek).
Regarding claim 8, Kimmel modified by Malkowski discloses the delivery system of claim 1, as described above. Kimmel further discloses wherein actuation of the first control member (knob 20, fig. 2a) moves the first and second steering elements (ends 230, 252 of each rack screw 201, 202; [0062], fig. 2) so that tension is applied to one of the first and second actuation elements (320/340, fig. 2a) and compression is applied to the other of the first and second actuation elements (see relative positions of rack screws 201/202 in fig. 7a, rack screw 202 pulls on pull wire 340, applying tension, while rack screw 201 moves distally, releasing tension from and pushing on, therefore applying compression to, pull wire 340).
Alternatively, Kimmel modified by Malkowski is silent to compression being applied to the other one of the first and second actuation elements.
Bednarek, directed to a bi-directional steerable catheter control handle, teaches wherein actuation of the control member (knob 10, fig. 1, [0073]) moves the steering element (slides 30/32, fig. 4, [0073]) so that tension is applied to one of the first and second actuation elements (deflections wires 38a/b, fig. 4, [0073]) and compression is applied to the other of the first and second actuation elements ([0073] when the knob 10 is rotated such that the right slide 30 is urged proximally and the left slide 32 is urged distally, the deflection wire 38a connected to the right slide 30 is placed into tension and the deflection wire 38b connected to the left slide 32 is placed into compression).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the steering mechanism of Kimmel to explicitly place one of the first and second actuation elements in tension and the other in compression as taught by Bednarek since both references deal with pull wires steering catheters for in-plane deflection. One would have been motivated to make the modification because having the actuation members respond to both tension and compression ensures that the steerable end portion will deflect in the appropriate direction and slack will not stay in either pull wire during actuation in a new direction.
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kimmel modified by Malkowski, as applied to claim 1, and further in view of Hopkinson et al (US 20190314609 A1; hereafter Hopkinson).
Regarding claim 10, Kimmel discloses the delivery system of claim 1, as described above.
Kimmel modified by Malkowski is silent to wherein the first actuation element and the second actuation element are formed from a single pull wire. However, Examiner notes Kimmel [0075] sections “steerable sheath shaft 100 in accordance with the invention includes one or more pull-wires 320, 340” and “pull-wires 320, 340 are operably coupled to pull ring 440 (as best seen in FIG. 5B)”. Both pull wires are coupled to the same pull ring.
Hopkinson, in the art of steerable medical devices, teaches wherein the first actuation element (first wire 16, fig. 4a, [0065]) and the second actuation element (second wire 17, fig. 4a, [0065]) are formed from a single pull wire ([0065] a single wire may be utilized as the first wire 16 and the second wire 17 such that the single wire loops from a first proximal end to the distal end 12 of the drainage tube 10 and back to a second proximal end).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the two pull wires of Kimmel to be formed from a single pull wire as taught by Hopkinson since the pull wires of Kimmel attach to the same pull ring at the distal flexible portion of the catheter, and Hopkinson teaches a loop at the distal attachment point of a flexible catheter. It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the two actuation elements of Kimmel to be formed from a single pull wire as taught by Hopkinson because having a single pull wire ensures that as one end is pulled proximally, the other end is pulled distally through the length of the wire, and issues of slack building up in the wire can be avoided. Furthermore, this modification would ensure that the pull ring is securely attached to the pull wire since the pull wire would run through the pull ring from one side to the opposite side, and thus using an adhesive or welding process would not be necessary, thus possibly simplifying assembly of the device.
Claim(s) 11, 13, and 24-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimmel modified by Alvarez.
Regarding claim 11, Kimmel discloses a delivery system for delivering a medical device to a desired location, the delivery system comprising:
a handle (first and second mating portions 24/26, fig. 2a, [0061] Cover 2 of control handle 10 includes a first mating portion 24 and a second mating portion 26);
a catheter shaft (steerable sheath shaft 100, fig. 2a, [0061]) extending from a proximal end of the catheter shaft attached to the handle to a flexible distal end portion of the catheter shaft (deflectable tip portion 200, fig. 2a, [0067]) (see fig. 2a);
a steering mechanism attached to the handle for steering the flexible distal end portion of the catheter shaft, the steering mechanism comprising:
a steering element (ends 230, 252 of each rack screw 201, 202; [0062], fig. 2);
a control member (knob 20, fig. 2a, [0063] As seen in FIG. 2A, rotatable adjustment knob 20 includes internal threads 254 circumferentially disposed about an inner wall thereof);
an actuation element (first pull wire 320, fig. 2a, [0062]) extending from a proximal end of the actuation element attached to the steering element (see fig. 2a; [0062] First and second pull wires 320, 340 are routed and are operably coupled to ends 230, 252 of each rack screw 201, 202, respectively) to a distal end of the actuation element attached to the flexible distal end portion of the catheter shaft (100) (see fig. 5b; [0077] Pull wires 320, 340 are operably coupled at their distal end to an opening 440 in pull ring 442 positioned within lumen 300 at the deflectable tip 200 end of the steerable sheath shaft 100;
wherein actuating the control member (20, fig. 2a) of the steering mechanism moves the steering element (ends 230, 252 of each rack screw 201, 202; see fig. 2a) to increase tension in the actuation element (320/340, fig. 2a) and actuating the control member of the steering mechanism in a second direction moves the steering element to release tension in the actuation element ([0080] rotation of knob 20 pulls second pull wire 340 proximally while releasing tension on first pull wire 320);
wherein the steering mechanism comprises:
a drive gear (first and second pinion gears 204, 206; fig. 2a; [0061]); and
a driven gear (internal central channel of rack screw 201 with threaded portion 211; fig. 2a; [0062] An internal central channel of each of first and second rack screws 201, 202 includes a threaded portion 211 that threadably receives pinion gears 204, 206 in operation).
Kimmel is silent to a stopper and compression coil.
Alvarez, in the art of steerable medical devices, teaches a stopper (interface slide 1308, fig. 13c, [0084] interface slide 1308 is disposed in the control unit 1300 to which the proximal end of the catheter 1302 attaches as shown in fig. 13a) coupled to at least one of the handle, the catheter shaft, and the steering mechanism (see fig. 13A-13C, stopper 1308 is coupled to the handle 1300 and steering mechanism; [0084] “interface slide (1308) may be operated by a drive mechanism or an interface slide carriage (1310) located in the instrument driver (1316) of a robotic system, as illustrated in FIG. 13D”) such that a position of the stopper is proximally and distally adjustable relative to the handle (see fig. 13C, [0084] “interface slide carriage to be moved or displaced, such that the interface slide maybe displaced to act on the flex tubes (1306)”);
a compression coil (flex tube 1306, fig. 13B, [0060] “flex tube may be constructed from one continuous coil of wire, e.g. coil tube”, see similar flex tube 306 in fig. 3A) surrounding the actuation element (anchor wire 1314-2, [0061], figs. 3a and 3b show compression coil 306 surrounding actuation element 314; see fig. 13B which likewise shows flex tube 1306 disposed over actuation element 1314-2);
wherein the compression coil (1306) extends from a proximal end of the compression coil that is attached to the stopper (1308) (see similar embodiment in fig. 3A; push tubes or control members 308, fig. 3a, [0063] push tubes/control members 308 are attached to flex tubes at anchoring points 320) into the catheter shaft (see fig. 13A and 13B which shows flex tube 1306 extending into the catheter; see also similar embodiment in fig. 3b which shows catheter shaft 302 over flex tube 306, fig. 3b, [0063]);
wherein the proximal and distal adjustment of the stopper relative to the handle adjusts a position of the proximal end of the compression coil relative to the handle (see fig. 13C, [0084] “interface slide carriage to be moved or displaced, such that the interface slide maybe displaced to act on the flex tubes (1306)”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify Kimmel to include the stopper and compression coil taught by Alvarez since both deal with steerable medical devices using pull wires. One would have been motivated to make the modification by Alvarez [0059] which notes that “the flex tubes (306) may also be utilized as support or reinforcing structures to vary or change the stiffness and/or bend radius of at least a portion of the catheter” and “the changes of stiffness along various portions of the elongate instrument or catheter may substantially affect the bend radius of at least a portion of the elongate instrument as pull wires are operated to articulate or steer the elongate instrument”. These benefits would facilitate the advancement of the catheter through sections requiring stiffness or to push through blockages but also allow the catheter to relax as necessary to avoid damaging delicate treatment sites. Additionally, the flex tubes would allow for further complex manipulation of multiple sections of the catheter.
Regarding claim 13, Kimmel modified by Alvarez discloses the delivery system of claim 11, as described above. Kimmel further discloses wherein the actuation element (320, fig. 2a) is attached to the driven gear, and wherein the driven gear comprises:
a rack (internal central channel of rack screw 201 with threaded portion 211; fig. 2a, [0062] An internal central channel of each of first and second rack screws 201, 202 includes a threaded portion 211) attached to the element (first pull wire 320, fig. 2a) ([0062] First and second pull wires 320, 340 are routed and are operably coupled to ends 230, 252 of each rack screw 201, 202, respectively).
Regarding claim 24, Kimmel modified by Alvarez in either alternative above discloses the delivery system of claim 11, as described above.
Alvarez fig. 4A-C, directed to a similar configuration, teaches wherein a service loop (buffer loops of the flex tubes in the control unit, noted in [0059]; service of buffer loop 402, fig. 4B, noted in [0059] and [0065] “flex members 306 may include a service or buffer loop 402”) is formed in the compression coil (306) (see fig. 4B).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Kimmel modified by Alvarez to include the service loop taught by Alvarez fig. 4A-C between the stopper 1308 and the catheter shaft, since the compression coil 1306 is already between the stopper and the catheter shaft, and since Alvarez fig. 4A-C is also focused on articulation of an elongated instrument through anatomy. One would have been motivated to make the modification because, as noted by Alvarez [0065], “the service loop or buffer loop (402) on the flex members (306) may provide the extra service length or buffer length needed for articulation as the elongate instrument (300) is pushed through the anatomy, articulated or steered.”
Regarding claim 25, Kimmel modified by Alvarez discloses the delivery system of claim 23 (see 112b interpretation above, note that claim 25 is interpreted to depend from claim 24, not claim 23), as described above, including wherein a size of the service loop is adjusted by the proximal and distal adjustment of the stopper relative to the handle (Examiner notes that since the stopper 1308 moves relative to the handle and pushes the flex tube 1306, causing the coil to compress, and since the service loop as shown in fig. 4A-C is part of the flex tube, the length of the service loop would also change due to compression/relaxation when the stopper 1308 is moved.).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kimmel modified by Malkowski and applied to claim 1 above, and further in view of McDermott et al (US 20180021546 A1; hereafter McDermott).
Regarding claim 23, Kimmel modified by Malkowski discloses the delivery system of claim 1, as described above.
Kimmel modified by Malkowski is silent to wherein the intermediate link, ring, or vertebrae and the distal link, ring, or vertebrae of the flexible distal end portion are formed by cutting a tube.
McDermott, in the art of steerable catheters, teaches wherein an intermediate link, ring, or vertebrae (see figs. 3 and 4 which show multiple vertebrae) and a distal link, ring, or vertebrae (see figs. 3 and 4 which show multiple vertebrae) of the flexible distal end portion (skeleton 30, figs. 3 and 4, [0037]) are formed by cutting a tube ([0037] FIG. 3 shows an enlarged view of a portion of metal tube or skeleton 30 that forms a bendable portion of a reinforcing structure of a steerable catheter.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the flexible distal end portion of Kimmel modified by Malkowski to be include the plurality of vertebrae formed by cutting as taught by McDermott since all three references deal with flexible medical tubes actuated by pull wires (see McDermott [0036]). One would have been motivated to make the modification because, as noted by McDermott [0037] “When a bending force is exerted on the metal tube for example by pull wires, the metal tube will bend in a simple curve in a plane”. This modification thus provides for predictable bending behavior which allows a clinician to deform the flexible distal end in a predictable direction. Furthermore, since all the vertebrae are formed together from a single material, all the sections are firmly attached to the adjacent sections since they are formed as one piece (see also McDermott figs. 3 and 4).
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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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 04/16/2026
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