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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot according to new ground of rejection discussed below.
Applicant argues Davies fails to disclose or suggest at least “a plurality of control wires, attached to the actuator and the controllable portion of the medical device, that are independently linearly moved by the actuator to manipulate a position of the controllable portion of the medical device such that operation of the actuator creates tension in one control wire of the plurality of control wires without creating slack in any other control wires of the plurality of control wires,” as recited in amended independent claim 1 (independent claims 9 and 12 recite similar features” since Davies does not disclose or suggest that the translation of the slide assembly can place one control wire (e.g., 40) in tension without creating slack in the other control wire (e.g., 42) because Davies discloses “… as the knob is rotated further in the clock-wise direction, movement of the carriage 34 causes the crimp 41 to translate proximally, pulling control wire 40 and placing it in tension”, “as the carriage 34 moves toward the proximal end of the handle 100 upon rotation of the knob 100, slack may be created in control wire 42”. Yamagishi, Kim, Olson fails to bridge the gap in teachings of Davis (pages 8-11).
In response, Examiner agrees Davies, in last three lines of paragraph 0116, states “Additionally, as the carriage 34 moves towards the proximal end of the handle 100 upon rotation of the knob 10, slack may be created in control wire 42.” However, this disclosure is just a portion or alternative embodiment described in Davies. In fact, Davies also states “in some embodiments, a means may be provided for preventing or limiting any slack created in control wire 42 from traveling to the segment of control wire 42 that is in contact with the pulley 52…. A slack limiting or containing element 60 may be provided to limit or contain any slack in control wire 42 as tension is removed from the wire 42” when another wire 40 is pulled/placing in tension (see paragraph 0119). The slack limiting or containing element 60 functions to prevent any slack generated in wire 42 from traveling to or affecting the segment of wire 42 that is positioned around the pulley 52” when wire 40 is in tension/pulled (see paragraph 0120).
Since Davies discloses slack containing element/means prevents or contains any slack generated in wire 42 from travelling to or affecting the segment of wire 42 when the other wire is in tension, Davies obviously discloses the feature of “operation of the actuator creates tension in one control wire of the plurality of wires without creating slack in any other control wires of the plurality of control wires” (when the knob creates tension in (pulls) one control wire (40) of the plurality of wires (40, 42), the slack containing element prevents or contains any slack in control wire 42. As a result of any slack generated in wire 42 is prevented/contained, no slack (without slack) is created in any other wires (42) of plurality control wires (40, 42).
It is also noted that “operation of the actuator creates tension in one control wire of the plurality of control wires without creating slack in any other control wires of the plurality of control wires” is well-known in the art. For example, Furnish et al. (US 20220062587: figure 7, paragraph 0026) discloses operation of lever 52 creates tension (pulling) on one control wire (42) of plurality of control wires (42, 44) without creating slack (does not pulling, pushing, preventing buckling) in other wire (e.g., 44) of the plurality of control wires (42,44); or Awtar (US 20180080533: see paragraphs 0016, 0027, 0122, 0124, 0134, 0137, 0145, figures 12A-15B, 25C-26B), or Haraguchi (US 20160338571: paragraphs 0050, 0059, figures 7, 9); KIrschenman et al. (US 20090247943: figures 10a-10b, 13a-13b, paragraph 0013, 0026) discloses each wire is individually controlled by each element 716,718,720,722, or 742-748 without creating backlash of any other wires.
Although Davies obviously disclose “operation of the actuator recreates tension in one control wire of the plurality of control wires without creating slack in any other control wires of the plurality of control wires” as recited in claim 1 (and similar feature in independent claims 9, 12) as discussed above, Furnish or Awtar is also relied on this teaching to provide a clear support that the limitation is well-known in prior art.
For the reason above, rejection of claims 1-20 are discussed below.
Examiner’s note
Once again, it is noted that according to MPEP 2111.04, “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are: “adapted to” or “adapted for” clause…”
Thus, the clause “adapted to” recited in the claims such as claim 1 (line 3), 12 (line 2), 20 (line 4) could be considered as language that suggests or makes optional but does not require the steps to be performed or does not limit a claim to a particular structure.
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.
Claims 1-2 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 20200324082) in view of either Furnish et al. (US 20220062587) or Awtar (US 20180080533).
It is noted that all documents that are directly or indirectly incorporated by reference in its entirety in the cited references (see for example, Awtar: paragraph 0001) are treated as part of the specification of the respective cited reference (MPEP 2163.07b).
Regarding claim 1, Davies discloses apparatus for manipulating a controllable portion of a medical device (steerable medical device for manipulating a controllable portion with control wires of a media device – see for example, figures 2b, 4E-5A), paragraphs 0006, 0067) comprising:
an actuator, adapted to receive an input rotary force, for converting the rotary force into linear motion (actuation mechanism/actuator, adapted to receive an input rotary force of the handle knob for converting/translating the force caused by rotating of the knob into a linear motion of the slide assembly 30– see for example, paragraphs 0006, 0077, 0107, 0134); and
a plurality of control wires, attached to the actuator and to the controllable portion of the medical device, that are independently linearly moved by the actuator to manipulate a position of the controllable portion of the medical device (a plurality of wires 40, 42, attached to the actuation mechanism/actuator and to the controllable portion that are independently/separately moved (one of the control wires is pulled) in linear direction or sliding by the actuation mechanism/actuator to manipulate a position of the controllable portion such as sliders, wires, etc. of the medical device – see include, but are not limited to, figures 5A, 12B, 15E, paragraphs 0006, 0067, 0077-0078, 0115-0116, 0123) such that operation of the actuator creates tension in one control wire (40) of the plurality of control wires (e.g., control wires 40, 42) prevents or contains any slack in other control wire (42) of the plurality of control wires (40, 42) – see include, but are not limited to, paragraphs 0119-0120 and discussion in “response to arguments” above.
As explained in the “response to arguments above”, Davies states “in some embodiments, a means may be provided for preventing or limiting any slack created in control wire 42 from traveling to the segment of control wire 42 that is in contact with the pulley 52…. A slack limiting or containing element 60 may be provided to limit or contain any slack in control wire 42 as tension is removed from the wire 42” when another wire 40 is pulled/placing in tension (see paragraph 0119). The slack limiting or containing element 60 functions to prevent any slack generated in wire 42 from traveling to or affecting the segment of wire 42 that is positioned around the pulley 52” when wire 40 is in tension/pulled (see paragraph 0120).
Since Davies discloses slack containing element/means prevents or contains any slack generated in wire 42 from travelling to or affecting the segment of wire 42 when the other wire is in tension, Davies obviously discloses the feature of “operation of the actuator creates tension in one control wire of the plurality of wires without creating slack in any other control wires of the plurality of control wires” (when the knob creates tension in (pulls) one control wire (40) of the plurality of wires (40, 42), the slack containing element prevents or contains any slack in control wire 42. As a result of any slack generated in wire 42 is prevented/contained, no slack (without slack) is created in any other wires (42) of plurality control wires (40, 42).
Additionally and/or alternatively, Furnish discloses a plurality of control wires (42, 44) attached to actuator ( lever 52) and to the controllable portion of the medical device that are independently moved by the actuator to manipulate a position of the medical device such that operation of the actuator (rotating of the lever 52) creates tension in one control wire (44) of the plurality of control wires (42,44) without creating slack (preventing buckling, no pushing or pulling) in any other control wires (42) of the plurality of control wires (42, 44) – see include, but are not limited to, figures 7-9, paragraphs 0026, 0032. It is noted as shown in figures 7-8, when control wire 44 is in tension/pulled as result of rotating lever 52, control wire 42 remains in the same position/neutral position (without slack) as previously shown in figures 6, 9. When control wire 42 is in tension/pulled as shown in figure 10, control wire 42 remain in neutral position and has no slack).
Awtar also discloses a plurality of control wires (for example, wires 1511, 1513, 2393, 2396, 2609, 2617 – see figures 15C, 15D, 23A, 23B, 26A, 26B) attached to actuator and to controllable portion of medical device that moved by the actuator (driving pulley or actuator) to manipulate a position of media device such that the operation of the actuator creates tension in one control wire (e.g., 1511, 2393, 2609) of the plurality of control wires 1511, 1513…) without creating slack (eliminate or remove slack) in any other control wires (1513, 2396, 2617) of plurality of control wires (1511, 1513, 2393, 2396, 2609, 2617) – see include, but are not limited to, figures 15C, 15D, 23A, 23B, 26A, 26B, paragraphs 0016, 0027, 0122, 0124, 0145).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davies with the teachings including operation of actuator creates tension in one control wire of plurality of control wires without creating slack in any other control wires of the plurality of other control wires as taught by either Furnish or Awtar (hereinafter referred to as Furnish/Awtar in order to yield predictable result of removing slack or preventing slop or backlash or reducing negative impact the operation of the device (see Awtar: paragraphs 0010, 0145) or preventing buckling and damage to the control wires (see Furnish: last 2 lines in paragraph 0026).
Regarding claim 2, Davies in view of Furnish/Awtar discloses the apparatus of claim 1, wherein the input rotary force is generated through movement of at least one of a lever or a knob (e.g. control knob 10 – see figure 1, paragraphs 0076- 0077).
Regarding claim 9, limitations of a method recited in claim 9 that correspond to the limitations of the apparatus in claim 1 are analyzed as discussed in the rejection of claim 1. Particularly, Davies in view of in view of Furnish/Awtar discloses a method of operation of a medical device comprising:
receiving input rotary force;
converting the input rotary force into a linear motion; and
coupling the linear motion to one control wire that is coupled to a controllable portion of the medical device to manipulate a position of the controllable portion of the medical device by creating tension in the one control wire without creating slack in any other control wires that are coupled to the controllable portion of the media device (see similar discussion in the rejection of claim 1 and Davis: paragraphs 0076-0077; Furnish: figures 6-10, paragraphs 0026, 0032; Awtar: figures 15C, 15D, 23A, 23B, 26A, 26B, paragraphs 0016, 0027, 0122, 0124, 0145).
Regarding claim 10, additional limitations of method that correspond to the additional limitations of apparatus in claim 2 are analyzed as discussed in the rejection of claim 2.
Regarding claim 11, Davies in view of Furnish/Awtar discloses the method of claim 9, the converting further comprises using a wire manipulator to linearly move at least one control wire, while maintaining at least one other control wire in a stationary position (a wire controller with carriage 34 to linearly move at least one control wire 40 and place it in tension while the at least one other control wire 42 remains in a neural or relaxed state – see paragraphs 0116, 0124).
Regarding claim 12, limitations of a medical device that correspond to the limitations of claim 1 are analyzed as discussed in the rejection of claim 1. Particularly, Davies in view of Furnish/Awtar discloses a medical device comprising:
an actuator, adapted to receive an input rotary force, for converting the rotary force into linear motion (see similar discussion in the rejection of claim 1, and paragraphs 0077, 0107, 0116);
a hollow flexible shaft, coupled to the actuator, having a controllable position proximate a distal end of the hollow flexible shaft (shaft of slide assembly 30 and/or the steerable sheath 90 coupled to the actuation mechanism/actuator, having controllable position proximate a distal end of the sliding assembly and/or sheath 30, see for example, figures, paragraphs 0077, 0111, 0119, 0137); and
a plurality of control wires (at least two control wires 40, 42), attached to the actuator and to the controllable portion, that is linearly moved by the actuator to manipulate a position of the controllable portion of the medical device when the actuator create tension in one control wire of the plurality of control wires without creating slack in any other control wires of the plurality of control wires (see similar discussion in the rejection of claim 1 and Davies: paragraphs 0077, 0136; figures 15C, 15D, 23A, 23B, 26A, 26B, paragraphs 0016, 0027, 0122, 0124, 0145; Furnish: figures 6-10, paragraphs 0026, 0032).
Regarding claim 13, Davies in view of Furnish/Awtar discloses the medical device of claim 12, wherein the input rotary force is generated through movement of at least one of a lever or a knob (see similar discussion in the rejection of claim 2).
Claims 3-5, 7, 14-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 20200324082) and view of either Furnish et al. (US 20220062587) or Awtar (US 20180080533) as applied to claim 2 and in view of Yamagishi et al. (US 6458010).
Regarding claim 3, Davies in view of Furnish/Awtar discloses the apparatus of claim 2, wherein the at least one lever or knob is coupled to a manipulator drive part which, when the input rotary force is applied, the actuator moves the one control wire without moving the any other control wires in the plurality of control wires (at least one handle knob 10 is coupled to a rotatable control mechanism which, when the input rotary force is applied to the handle knob, the actuation mechanism/actuator move a guidewire of control wire 40 to tension while the other control wire is in neural or relaxed state or not moving– see for example, Davis: figures 2B, 4E, 4F, paragraphs 0065-0067, 0103, 0116, 0124 or see Furnish: figures 7, 10, paragraphs 0026, 0032).
However, Davies does not explicitly disclose the manipulator drive part is a manipulator drive gear.
Yamagishi discloses at least one lever or knob is coupled to a manipulator drive gear which, when the input rotary force is applied, the actuator moves the one of control wire in a plurality of control wires (ends 24d or 24e is coupled to a manipulator drive gear mechanism which when force is applied in response to rotation, the actuator moves a one control wire (e.g., 24a) in plurality of control wires – see include, but are not limited to, col. 9 lines 9-30, col. 11, lines 38-20).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Davies with the teaching of manipulator drive gear as taught by Yamagishi in order to yield predictable result of easily carrying out a rotating control of a cylindrical member together with a wire around (see col. 2, lines 38-46).
It is noted that Furnish also discloses at least one lever (52) is coupled to a manipulator drive gear that controls the wires 42, 44 individually (see figures 3,6-10, paragraphs 26, 29-30).
Regarding claim 4, Davis in view of Furnish/Awtar and Yamagishi discloses the apparatus of claim 3, wherein the actuator comprises: a wire manipulator comprising a pair of sliders that are slidably mounted to a platform (a wire manipulator comprising a pair of upper and lower sliders 63 and 64 that are slidably mounted to a platform – see for example, Yamagishi: col. 9, lines 36-67, figures 13-14);
each control wire in the plurality of control wires is coupled to one of the sliders in the pair of sliders (each control wire 24a, 24b, is coupled to one of the sliders in the pair of sliders 63, 64 – see for example, Yamagishi, figures 13-14) ; and
the pair of sliders are coupled to the manipulator drive gear (the pair of sliders 63, 64 are coupled to the manipulator drive gear of gear mechanism – see for example, Yamagishi: figures 10, 13-14, col. 9, lines 10-67).
Regarding claim 5, Davies in view of Furnish/Awtar and Yamagishi discloses the apparatus of claim 4, wherein the manipulator drive gear comprises a pair of spaced apart posts and each post interacts with a slot formed in each slider in the pair of sliders (a pair of upper and lower pin shaped wire driving parts 65 and 66 and each part 65 or 66 interacts with a slot form in each slider of the pair of sliders 63, 64 – see for example, Yamagishi: col. 9, lines 52-66, figures 16-17).
Regarding claim 7, Davies in view of Furnish/Awtar and Yamagishi discloses the apparatus of claim 5, wherein each slider comprises an upper and lower guide portion and the platform comprises a retainer that retains the sliders upon the platform while allowing the sliders to move linearly relative to the platform (each slider 63, 64 comprises an upper and lower guide portion with upper and lower guide rails 62a, 62b and platform of slide guide 62 comprise a retainer that retains the sliders 63, 64 upon the platform of slide guide 62 while allowing the sliders to move linearly relative to the platform - see for example, Yamagishi: figures 14-17, col. 10, lines 3-22, lines 53-66, col. 11, lines 5-17).
Regarding claims 14-16, 18, the additional limitations of the media device that correspond to the additional limitations of the apparatus of claims 3-5, 7 and are analyzed as discussed in the rejection of claims 3-5, 7 respectively.
Claims 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 20200324082) in view of either Furnish et al. (US 20220062587) or Awtar (US 20180080533) and Yamagishi et al. (US 6458010) as applied to claim 5 and further in view of Kim (US 5,477,267).
Regarding claim 6, Davies in view of Furnish/Awtar and Yamagishi discloses the apparatus of claim 5. However, Davies in view of Yamagishi does not explicitly disclose slot comprises a horizontal slot and an arcuate slot.
Kim discloses slot comprises a horizontal slot and an accurate slot (read on guide slot comprising horizontal portion and sloped portion – see col. 2, lines 46-49, col. 3, lines 56-60, col. 5, lines 1-5, figure 4A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Davies in view of Furnish/Awtar and Yamagishi with the teaching of a slot comprises a horizontal slot and an accurate slot (slopped portion) as taught by Kim in order to yield predictable result of improving accuracy of controlling guiding in different directions such as backwards and upwards (see Kim: col. 5, lines 2-5).
Regarding claim 17, the additional limitations of the medical device that correspond to the additional limitations of the apparatus in claim 6 are analyzed as discussed in the rejection of claim 6.
Claims 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 20200324082) in view of either Furnish et al. (US 20220062587) or Awtar (US 20180080533) and Yamagishi et al. (US 6458010) as applied to claim 4 and further in view of Olson et al. (US 20100256558).
Regarding claim 8, Davies in view of Furnish/Awtar and Yamagishi discloses the apparatus of claim 4, wherein the platform has a first side and a second side and a first pair of sliders is slidably mounted to the first side (platform of slide guide 62 has first side and second side and the first pair of sliders 63, 64 is slidably mounted to the first side – see for example, Yamagishi: figures 6, 10, 12, 14). However, Davies in view of Furnish/Awtar Yamagishi does not explicitly disclose a second pair of sliders is slidably mounted to the second side.
Olson discloses a platform has a first side and a second side and a first pair of sliders is slidably mounted to the first side and a second pair of sliders is slidably mounted to the second side (platform 404 has a first side and a second side of sheath 410 and the first pair of sliders blocks 412, 414 is slidably mounted on the first side and a second pair of sliders 416, 418 is slidably mounted to the second side – see figure 5a, paragraph 0073).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davies in view of Furnish/Awtar and Yamagishi with the teaching of second part of sliders is slidably mounted to the second side as taught by Olson in order to independently tension select steering wires (paragraph 0073).
Regarding claim 19, the additional limitations of the medical device that correspond to the additional limitations of the apparatus of claim 8 are analyzed as discussed in the rejection of claim 8.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (US 20200324082) in view of either Furnish et al. (US 20220062587) or Awtar (US 20180080533)as applied to claim 12 and further in view of Olson et al. (US 20100256558).
Regarding claim 20, Davies in view Furnish/Awtar discloses the medical device of claim 12, wherein the plurality of control wires comprises two or more control wires are attached to the controllable portion at locations around a circumference of the hallow flexible shaft, wherein the actuator is adapted to linearly move each individual control wire independent of the other control wires (see similar discussion in the rejection of claim 12 and paragraphs 0066-0067, 0077, 0137).
However, Davies does not explicitly disclose plurality of control wires comprises four and the four control wires are attached to the controllable portion at 90-degree locations.
Olson discloses plurality of control wires comprises four and the four control wires are attached to controllable portion at 90-degree locations around a circumference of the hollow flexible shaft, where an actuator is adapted to linearly move each individual control wire independently of the other three control wires (four steering wires are attached to controllable portion and the steering wires spaced approximately 90 degree apart around the sheath 410 wherein an actuator is adapted to linearly move each of the wire independently of the other three wires – see include, but are not limited to, figures 5a, 20-22, 31, paragraphs 0008, 0073, 0084, 0151) .
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Davies in view of Furnish/Awtar and Yamagishi with the teaching of four control wires attached to controllable portion at 90-degree location as taught by Olson in order to independently tension select steering wires in 90-degree location/direction (paragraphs 0073, 0151).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Donnell et al. (US 8911397) discloses steerable sheath handle pulley mechanism comprising eliminating slack of pull wires (see also claim 10).
Konomura (US 20100160730) discloses endoscope with two wires are in a tense state without a slack (see paragraph 0005).
Haraguchi (US 20160338571) discloses moveable part can go into operation without any slack in wires (paragraphs 0050, 0059, 0072).
Suh et al. (US 2020000318) discloses cable actuation mechanism for steering endoscope and preventing cable slack (paragraph 0008).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AN SON P HUYNH whose telephone number is (571)272-7295. The examiner can normally be reached 9:00 am-6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANH TUAN T. NGUYEN can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AN SON P HUYNH/Primary Examiner, Art Unit 2426
August 17, 2026
Prosecution Insights