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
The previous objection of claims 7 and 10 due to minor informalities has been withdrawn in light of applicant’s amendments made 6/18/2026.
The previous rejection of claim(s) 2-4, 10-12 and 14 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 2-4, 10-12 and 14 on 6/18/2026.
The previous claim interpretation under 35 U.S.C. 112(f) has been withdrawn due to the amendments made to claims 5 and 8 on 6/18/2026.
The rejection of claims 1-2, 5-11 and 13-14 under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US 6,571,131 B1) has been withdrawn in light of applicant’s amendment made 6/18/2026. Specifically, Nguyen does not teach wherein each set of control wires extends a length to a bendable segment distal end different for each bendable segment.
Applicant’s arguments with respect to claims 1, 5-14 and 21-25 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Tanaka (US 2018/0242820 A1) teaches said limitation.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the length” in line 3 which should read “a length” for consistency purposes. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: Claim 13 recites “the anchor” in line 1 which should read “the respective anchor”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7 and 21-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites “wherein a tube is crimped onto an end of each control wire” in lines 1-2. Support for claim 21 can be found in Figs. 7-10 which provide a tube 54 that is crimped onto the control wire 9 ([0058]). However, claim 21 depends from claim 1 which recites “an anchor configured on each control wire” and paragraphs [0052]-[0058] of the specification make it clear that the tube 54 is the anchor. Therefore, applicant does not have support for both an anchor crimped and welded to each control wire as required in claim 1 and an additional tube crimped onto an end of each control wire. Claims 22-23 and 25 are rejected for similar reasons as they also claim “a tube” in addition to the anchors of claim 1.
Claim 24 recites “wherein an end of each control wire is ball welded to from a mechanical stop.” Support for claim 24 can be found in paragraph [0058] which recites “The end of the control wire 9 is ball welded to form a mechanical stop. The ball weld keeps the control wire 9 from being pulled out of the tube 54, while the crimp 56 does the same, but also keeps the control wire 9 from being pushed out of the tube. The crimp 56 provide purchase for the plastic to anchor the assembly in the plastic.” In other words, embodiments which use a ball welds use tubes/anchors with crimps, not welds as “welding is no longer as good an option to connect the two components” ([0057]). Claim 1 from which claim 24 depends recites “wherein the anchor is affixed to the plurality of sets of control wires by crimping and welding.” Thus, applicant has combined mutually exclusive embodiments in claim 24 in which the specification does not support.
Accordingly, claims 21-25 contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 1, 5-14 and 21-25 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 1 recites “for each set of control wires, the anchor” in line 12. However, each control wire is configured with an anchor. Therefore, each control wire of each set of control wires includes an anchor and it is unclear which or if all anchors are intended to be claimed in line 12. For the purposes of examination, the limitation has been interpreted to read “for each set of control wires, the respective anchor.” Similarly, it is unclear as to which anchor is being claimed in line 14. For the purposes of examination, the limitation has been interpreted to read “the respective anchor.”
Claim 5 recites “the anchor” in line 1. It is unclear as to which or if all of the anchors are intended to be claimed. For the purpose of examination, the limitation has been interpreted to read “each anchor.”
Claim 7 recites “wherein the plurality of sets of control wires include a plurality of anchors” in lines 1-2. Claim 7 depends from claim 1 which recites “a plurality of sets of control wires slideably situated in the wall, each set of control wires having a plurality of control wires; and an anchor configured on each control wire.” Therefore, claim 1 already includes a plurality of anchors for each set of control wires. It is unclear if the anchors of claim 7 are intended to be the same or in addition to those of claim 1. For the purposes of examination, the anchors of claim 7 are interpreted as the same as those recited in claim 1.
Claim 8 recites the limitation "the at least one control wire" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the plurality of sets of control wires and anchor” in lines 1-2. It is unclear as to which or all of the anchors are being claimed.
Additional dependent claims not listed are rejected based on their dependency to rejected claim 1.
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.
Claim(s) 1, 5-11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 6,571,131 B1) in view of Tanaka (US 2018/0242820 A1) in view of Hanenburg (US 2019/0351189 A1).
Regarding claim 1, Nguyen discloses a medical apparatus (catheter 10; Fig. 1) comprising: a bendable body (deflectable tip section 13) comprising: a hollow cavity (central lumen 18) extending the length of the bendable body (Figs. 1-4), the bendable body having a bendable segment (deflectable tip section 13; Fig. 1); and a wall (wall of 13 and/or 12 including at least tubing 21) formed about the hollow cavity (Figs. 1-4); a set of control wires (set of four puller wires 31; Fig. 2) slideably situated in the wall (as puller wires are moved longitudinally by the control handle 14; column 6, lines 58-63), the set of control wires having a plurality of control wires (wires 31); and an anchor (anchor 35; Figs. 4, 5A-5B) configured on each control wire (as anchor 35 is fixedly attached to the distal end of the puller wires 31; Figs. 4, 5A, 5B; columns 5-6, lines 64-67, 1), wherein the set of control wires extends a length to a bendable segment distal end (Fig. 6A), wherein, for the set of control wires, the respective anchor is affixed within the wall at the distal end of the bendable segment (cross-piece 38 of anchor 35 lies within the notch 39 of the wall of the tip section 13; Fig. 4; column 6, lines 9-19), and wherein the anchor (35) is affixed to the control wire (31) by crimping (anchor 35 made from metal tube 37 may be fixedly attached to the puller wire 31 by crimping; column 6, lines 1-5).
Nguyen fails to disclose the bendable body having a plurality of bendable segments, the wall extending through the plurality of bendable segments, a plurality of sets of control wires, each set of control wires having a plurality of control wires, wherein each set of control wires extends a length to a bendable segment distal end different for each bendable segment, wherein, for each set of control wires, the respective anchor is affixed within the wall at the distal end of the corresponding bendable segment, and wherein the respective anchor is affixed to the plurality of sets of control wires by crimping and welding.
However, Tanaka teaches a medical apparatus (wire-driven manipulator 1) comprising a bendable body with one bendable portion (bendable distal portion 2; Fig. 1B), similar to that of Nguyen, or alternatively, a bendable body with a plurality of bendable segments (bendable distal portions 2a, 2b; Fig. 6), the bendable body includes a hollow cavity (lumen within guide members 7 and guide tube 8) extending the length of the bendable body (Fig. 6), a wall (formed by guide members 7) formed about the hollow cavity and extending through the plurality of bendable segments (Fig. 6); a plurality of sets of control wires (set of three members 5 associated with each of the bendable distal portions 2a, 2b; [0032]) slideably situated in the wall (Fig. 6; [0032]), each set of control wires having a plurality of control wires (three members 5), wherein each set of control wires extends a length to a bendable segment distal end different for each bendable segment (as three members 5 extend to the distal end of 2a and three members 5 extend to the distal end of 2b; Fig. 6; [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bendable body of Nguyen from a single bendable segment to a plurality of bendable segments with a plurality of sets of control wires, wherein each set of control wires extends a length to a bendable segment distal end different for each bendable segment as taught by Tanaka in order to selectively manipulate different sections of the bendable body to better adapt to a patient’s anatomy. Such a modification would result in all of the control wires including anchors 35 of Nguyen affixed to different sections of the wall at distal ends of each bendable segment.
Nguyen modified fails to explicitly disclose wherein the anchor is affixed to the control wire by crimping and welding. Instead, Nguyen discloses wherein the anchor (35) is affixed to the control wire (31) by crimping (anchor 35 made from metal tube 37 may be fixedly attached to the puller wire 31 by crimping; column 6, lines 1-5).
However, Nguyen teaches an anchor (anchor 42) may be crimped to the control wire (31) or alternatively may be welded to the control wire (31; as cross-member of the anchor 42 may be welded to the proximal end of the puller wire 31; columns 10-11, lines 67, 1-10). Nguyen further teaches any suitable mechanism for anchoring the control wire to the anchor (42) may be used (column 11, lines 10-12).
Hanenburg teaches a medical apparatus (catheter 10; Fig. 1) comprising a bendable body (deflectable catheter shaft section 12; Fig. 1) with at least one control wire (pullwire 150; Fig. 4A); and an anchor (anchor feature 152) configured on the at least one control wire (Fig. 4A), wherein the anchor (152) is affixed to the control wire by both crimping and welding (as a bead of weld can be used to attach the rounded end 158 of the anchor feature 152 onto the pullwire distal end 156 and/or the rounded end 158 can be press fit and/or crimped onto the pullwire distal end 156; [0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor of modified Nguyen to be affixed to the control wire by crimping and welding in light of the teachings of Nguyen and Hanenburg. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of affixing the control wire to the anchor.
Regarding claim 5, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses wherein the anchor (35) is further configured to have additional surface area (surface area of 38; anchor 35 includes a cross-piece 38 that creates a notch between 38 and metal tube 37; Fig. 5A) on an outside surface of the anchor for increasing an attachment strength of the anchor to the wall (Figs. 4, 5A).
Regarding claim 6, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses wherein the additional surface area on the outside surface of the anchor is selected from the groups consisting of a notch, a hole, a fissure, a loop, and combinations thereof (as anchor 35 includes a cross-piece 38 that creates a notch between 38 and metal tube 37; Fig. 5A).
Regarding claim 7, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses wherein the plurality of sets of control wires (sets of modified Nguyen) includes a plurality of anchors (distal anchors 35 and proximal anchors 42; Figs. 4, 5A-5B, 7), wherein the position of each anchor is different along the axial direction of the bendable body (as anchors 35 are positioned distally within tip section 13 and anchors 42 are positioned proximally within barrel 70; Figs. 4, 7). Further, the positions of the anchors of modified Nguyen are different along an axial direction of the bendable body as each set of anchors is positioned at a distal end of a different bendable segment (see claim 1 above).
Regarding claim 8, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses a driver (rotation knob 96 and sleeve 44) in communication with the at least one control wire (31), configured to transmit pushing and pulling force to actuate the at least one control wire in the wall (column 8, lines 37-61).
Regarding claim 9, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses wherein the plurality of sets of control wire further comprises an outer wire (coil 33) and an inner wire (31; Fig. 3), wherein the inner wire (31) is slideably nested within the outer wire (as coil 33 is glued to the catheter 12 at glue joint 34 and puller wire 31 extends through coil 33 to anchor 42 which are pulled to deflect the tip section 13; column 5, lines 26-28, 41-43; column 6, lines 58-63).
Regarding claim 10, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses wherein the outer wire (33) has an first anchor (glue joint 34) for affixing the outer wire to the wall (column 5, lines 54-61) and the inner wire (31) has a second anchor (35) for affixing the inner wire to the wall (Fig. 4), wherein the position of the anchor (34) for the outer wire (33) and the inner wire (31) are different along an axial direction of the bendable body (Figs. 3-4).
Regarding claim 11, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses wherein the plurality of sets of control wires (31) and anchor (35) comprise of a radio opaque material (as 31 may be made of stainless steel or nitinol and 35 is formed by a metal tube 37, and metals are radio opaque; column 5, lines 16-18; column 6, lines 1-3).
Regarding claim 13, the claimed phrase “heating the wall and anchor to create a thermal fusion” is being treated as a product by process limitation; that is the process of affixing the anchor to the wall. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In the instant case, Nguyen discloses the anchor (35) is affixed to the wall (Fig. 4); therefore, the structure of Nguyen is found equivalent to that claimed and additional process steps are irrelevant.
Regarding claim 14, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses wherein the wall comprises at least two wire guides (lumens 17), wherein the wire guides are spaced a distance from one another (Fig. 2).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 6,571,131 B1) Nguyen (US 6,571,131 B1) in view of Tanaka (US 2018/0242820 A1) in view of Hanenburg (US 2019/0351189 A1), as applied to claim 1 above, and further in view of Kowshik (US 2016/0067540 A1).
Regarding claim 12, Nguyen modified discloses the invention as claimed above, and Nguyen further discloses a functional probe (as catheter 10 includes ring electrodes 28 along the length of the tip section 13) but fails to disclose the functional probe selected from the group consisting of a position tracking sensor, a shape sensor, an endoscopic imaging probe, and combinations therefrom.
However, Kowshick teaches a medical apparatus (instrument system 200; Fig. 2) with a bendable body (elongated flexible body 216) and a functional probe comprising a shape sensor (shape sensor 222) for determining the position, orientation, speed, pose, and/or shape of the catheter tip at the distal end (218) and/or one or more segments along the body ([0045]-[0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical apparatus of modified Nguyen to further include the shape sensor as taught by Kowshick in order to determine the position, orientation, speed, pose, and/or shape of the bendable body.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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