Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "17" and "18" have both been used to designate “articulation link members”. 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. 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.
The drawings are objected to because:
The detailed description is unclear which figure it is referencing on page 8 line 11;
The specification references element 22 in figure 5 on page 8 line 8, however element 22 is only shown in figures 1a, 2, 4a, and 6;
The specification references element 25 in figure 4a on page 9 line 10, however element 25 is only shown in figure 1b;
The specification references element 12 in figure 7 on page 9 line 19, however element 12 is not shown in figure 7; and
The specification references elements 10, 15, and 22 in figure 7 on page 9 line 25, however figure 7 does not contain elements 10, 15, or 22.
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.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Claim Objections
Claim 9 objected to because of the following informalities: “further” should be added before the term “comprises” since claim 9 depends from claim 1, where the steerable articulating surgical instrument is already recited to include other elements including an external hollow shaft and a steering arrangement. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 10, and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the articulation arrangement" in line 4 and “the articulation members” in line 4. There is insufficient antecedent basis for this limitation in the claim. It is noted that if dependency for claim 7 is amended to depend from claim 6, this rejection would be overcome.
Regarding claim 7, the limitation of “the articulation members comprising corresponding link channels and the one or more articulation link members extending through the corresponding link channels” seems unclear. If articulation members are the corresponding link channels, it seems unclear how can the articulation members, which are the corresponding link channels, can be extending through the link channels.
Claim 10 recites the limitation "the end effector" in line 20 and “the internal hollow shaft” in line 22. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the one or more articulation link members" in line 25, “the internal shaft” in line 27, “the operation link member” in line 28, and “the end effector” in line 28. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 20210275266 A1, published on Sept. 9, 2021, hereinafter refer to as “Kim”).
Regarding claim 1, Kim teaches a steerable articulating surgical instrument for surgery (surgical apparatus in Fig. 54), comprising: an external hollow shaft (Fig’s 57-59 shows tubular structure that holds steerable member, see ¶[0209]) extending between a proximal end and a distal end, wherein the external hollow shaft comprises a bendable portion (steerable member 100 in annotated Fig. 2 below) adapted to allow deflection of the distal end (“a steerable member 100 at the distal end that is bendable at one or more locations across its length” in ¶[0071]); a steering arrangement adapted to apply a bending force to the bendable portion, wherein the bendable portion comprises a resilient bendable member (“lateral supporting members 130”, Fig.’s 12A-13C and ¶[0106] and [0108]) adapted to resist the bending force (“a plurality of wire members extending between a connection to the distal end of the surgical instrument 30 to the driving part 40, and a further plurality steering wires extending from the driving part 40 to the steerable member 100 and back to the driving part 40 extend" in ¶[0071]).
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Regarding claim 2, Kim teaches all of claim 1 and the resilient bendable member adapted to store mechanical energy during bending of the bendable portion when the bending force is applied and to release stored mechanical energy to unbend the bendable portion when the bending force is removed. (Fig.’s 12-14 and ¶[0105]).
Regarding claim 3, Kim teaches all of claim 1 and the external hollow shaft (Fig’s 57-59 shows tubular structure that holds steerable member, see ¶[0209]) extends along a central longitudinal axis, wherein the bending force is applied such that the bendable portion is deflected from the central longitudinal axis to move radially away from the central longitudinal axis (Fig.’s 12A-12C and ¶[0106]).
Regarding claim 4, Kim teaches all of claim 1 and the resilient bendable member comprises a spring (Fig.’s 12A-13C and “The lateral supporting members 130 may be configured in various types of structures, such as a wire structure or a hollow tube structure, that function as linear springs” in ¶[0108]).
Regarding claim 5, Kim teaches all of claim 1 and the resilient bendable member (130 in Fig.’s 12A-13C) is arranged longitudinally within the bendable portion such that the resilient bendable member extends through the bendable portion and supports the bendable portion (Fig. 13 element 130 and “include a plurality of lumens 112 through which the bending actuation wires 400 and the lateral supporting members 130 pass.” in ¶[0108]).
Regarding claim 6, Kim teaches all of claim 1 and the bendable portion (Fig. 2 elements 100 and 200) comprises an articulation arrangement (Fig. 2 element 100) comprising a plurality of adjacent articulation members (see annotated Fig. 13 below, element 110) arranged to articulate with respect to each other when the bending force is applied, (“when the bending actuation wires 400 are moved by the manipulating part 10, the plurality of bending segments 110 move hingedly, thus causing the steerable member 100 to bend” in ¶[0072] and Fig. 2) wherein the resilient bendable member is arranged to align the articulation members and to support the articulation members (Fig. 13 element 130 and “include a plurality of lumens 112 through which the bending actuation wires 400 and the lateral supporting members 130 pass.” in ¶[0108]).
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Regarding claim 7, Kim teaches all of claim 1 and the steering arrangement (Fig. 2 element 100) comprises one or more articulation link members arranged along the articulation arrangement (see annotated Fig. 13 above, element 110) and the external hollow shaft (Fig. 54 contains components of Fig. 2), the articulation members comprising corresponding link channels (Fig. 13 Element 112 and ¶[0108]) and the one or more articulation link members extending through the corresponding link channels (Fig. 13 Element 400 and “include a plurality of lumens 112 through which the bending actuation wires 400 and the lateral supporting members 130 pass.” in ¶[0108]).
Regarding claim 8, Kim teaches all of claim 1 and the steering arrangement comprises an internal shaft extending through the external hollow shaft (Fig. 54, the external housing comprises the steering arrangement of Fig. 2) engaging the resilient bendable member (Fig. 13 element 130) such that rotation of the internal shaft causes rotation of the resilient bendable member (Fig. 54 “each of the robotic controllers 1114a, b in the mechanical carriage 1100 are configured to cause independent rotating and linear movement of the second and third tubular members 1120, 1124 with respect to the mechanical carriage 1100 … and to rotate the robotic surgical arms 1166a, 1166b about the axis of the first and second tubular members 1120, 1124” in ¶[0216], where “the robotic surgical arms 1166a, each comprising a first steerable member 100a and a second steerable member 100b” ¶[0211]).
Regarding claim 9, Kim teaches all of claim 1 and the steerable articulating surgical instrument comprises an end effector (Fig. 2 "The end effector 300 comprises various types of surgical elements for use in surgery" in ¶[0141]), wherein the resilient bendable member (Fig. 13 element 130) is arranged to rotate the end effector, when the resilient bendable member rotates (“each of the robotic controllers 1114a, b in the mechanical carriage 1100 are configured to cause independent rotating and linear movement of the second and third tubular members 1120, 1124 with respect to the mechanical carriage 1100 … and to rotate the robotic surgical arms 1166a, 1166b about the axis of the first and second tubular members 1120, 1124” in ¶[0216] ], where “the robotic surgical arms 1166a, each comprising a first steerable member 100a and a second steerable member 100b” ¶[0211]).
Regarding claim 10, Kim teaches all of claim 1 and the steering arrangement comprises an operation link member (Fig. 2 and 24 element 500) extending through the external hollow shaft (Fig. 54 is the external hollow shaft comprising the device in fig. 2) and attached to the end effector (Fig. 2 element 300), wherein the resilient bendable member defines a conduit along the bendable portion and the operation link member is arranged to extend through the conduit and the internal hollow shaft (Fig. 2 element 500 extends through Fig. 54 and “500 is pulled in the direction of the manipulating part 10 …The action of pulling the effector actuation wire 500 in the direction of the manipulating part may be done easily by the driving part 40 of the manipulating part, thereby transmitting the force to the end effector“ in ¶[0143]).
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Kuehn et al. (US 6743239 B1, published on June 6, 2004, hereinafter refer to as “Kuehn”).
Regarding claim 11, Kim teaches all of claim 1 and a control unit (Fig. 54 element 1100 and ¶[0213]), a second knob (Fig. 54 element 1188 and ¶[0213]) engaging with the internal shaft to rotate the internal shaft (Fig. 61 depicts a rotated device containing the internal shaft , also see ¶[0223]) and an operation trigger (Fig. 54 element 1114) attached to the operation link member to operate the end effector (¶[0226]).
Kim does not teach a handle having a first knob attached to the one or more articulation link members to pull the respective one or more articulation link members.
Kuehn’s invention relates to medical devices or tools for performing surgical procedures, including heart valve repairs (Co. 1 lines 6-8) and these medical devices include endoscopes, orthoscopes, probes, catheters and the like can be inserted into a patient for the performance of various medical procedures (Col. 1 lines 12-13). The directional medical device generally includes a handle, a knob, a shaft, an optional malleable section and an articulating tip. The handle can be used by the surgeon to move the device into position. The knob is connected appropriately to the tip through a control mechanism such that movement of the knob at the proximal end alters the bending of the tip at the distal end of the device. The knob generally is attached at or near the handle such that the surgeon can easily move the knob to change the orientation of the tip. (Col. 4 lines 57-66) The articulating tip is connected by way of cords (articulation link members in claim 11) or other transmission devices to the knob at the proximal end of the device such that the knob can be used to control the bending of the tip at the distal end. (Col. 5 lines 17-20)
Therefore, it would have been obvious to a person having ordinary skill in the art (PHOSITA) before the effective filing date of the claimed invention to include a handle with a knob attached to the articulation link members of Kim as taught by Kuehn in order to provide a surgeon an easy way of changing the orientation of the surgical device from its handle.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tasci (US 10,799,224) contains a surgical instrument with a stable and bendable structure with a handle to manipulate the tool; and
Worrell et al. (US 10,258,363) contains a bendable surgical instrument with a handle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5 ET and alternate F 8-4 ET.
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/E.N.C./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792