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 Amendment
This office action is responsive to the amendment filed on 04/17/2026. As directed by the amendment: claims 10 and 15 have been amended, claims 1-2, 4-9, 11-14, and 16 have been cancelled, and claim 17 has been added. Thus, claims 10, 15, and 17 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the specification and claims have overcome each and every objection set forth in the Non-Final Office Action mailed on 10/22/2025 except the 112 issues with regards to claims 10 and 15.
Response to Arguments
Applicant’s arguments, see p. 7-10 of “Remarks”, filed 04/17/2026, with respect to the 103 rejection of claims 10 and 15 have been fully considered and are persuasive. The 103 rejection of 10/22/2025 has been withdrawn.
Claim Objections
Claim 10, 15, and 17 are objected to because of the following informalities:
Regarding claim 10, the phrase “a distal end of catheter tube” in line 2 should read “a distal end of the catheter tube” for proper grammar,
Regarding claim 10, the phrase “the proximate end of the catheter tube” in line 5 should read “the proximal end of the catheter tube” for proper antecedent basis,
Regarding claim 10, the phrase “an edge on the lever mechanism” in line 19 should read “an edge of the lever mechanism” for clarity,
Regarding claim 15, the phrase “the pair of semicircular vertical walls” in line 6 and line 10 should read “the pair of semicircular
Regarding claim 17, the phrase “the coupled to a respective guidewire” in line 40 should read “then coupled to a respective guidewire” for proper grammar.
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 10 and 15 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.
Regarding claim 10, the phrase “the lever mechanism having a pair of terminal points disposed symmetrically on a rear portion of the lever mechanism, each one of the pair of guidewire legs is coupled to a respective one of the terminal points” in lines 9-11 is new matter. The disclosure does not have support for a pair of terminal points disposed on a rear portion of the lever mechanism as the term “rear” is understood from the spec. In para. 0017 and Fig. 2, the terminal points are designated as points 96 illustrated on a distal side of the lever plate 151. However, in Fig. 2 and 7 and para. 0020 stating “two pairs of holes 153, 154 formed at the rear of the plate 151” which is contradictor to the claim limitation as these holes 153 and 154 are formed on the opposite side from the points 96. The specification nor the drawing provide support for this limitation. Thus, the limitation is new matter.
Regarding claim 10, the limitation “each one of the pair of the pair of guidewire legs is coupled for routing around a respective enlarged knob on one of the semicircular walls and through a respective one of the pair of tunnels to a respective terminal point” in lines 25-27 is new matter. The disclosure does not have support for the guidewire legs being the structure that routes around the knobs, semicircular walls, and through the tunnels. In Fig. 2 and para. 0017, the guidewire legs 94 are disclosed as attaching to a cable 95 at the terminal points 96, and the cable 95 is the structure wrapped around and affixed to the lever mechanism 150. The specification nor the drawing provide support for this limitation. Thus, the limitation is new matter.
Claim 15 is rejected due to its dependency upon a rejected base claim.
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 10 and 15 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.
Regarding claim 10, the phrase “each one of the pair of guidewire legs is coupled to a respective one of the terminal points” in lines 10-11 renders the claim indefinite because it is unclear. It is unclear if the pair of guidewire legs are physically coupled to the lever mechanism at the pair of terminal points as claimed, or if these points are just locations that a connection is formed wherein said location is disposed over the lever mechanism at some point in time during operation. Examiner is interpreting this limitation as the pair of terminal points are locations for connection disposed symmetrically near the edge portion of the lever mechanism.
Claim 10 recites the limitation "the interior region of the housing" in lines 14-15. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the lever plate" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, the phrase “a pair of semicircular walls formed and symmetrically disposed” in line 18 renders the claim indefinite because it is unclear. It is unclear what structure the walls are formed and symmetrically disposed on. Examiner is interpreting this limitation as the walls are formed and disposed on the lever mechanism.
Regarding claim 10, the phrase “a respective terminal point” in line 27 renders the claim indefinite because it is unclear. It is unclear whether this is the same terminal point aforementioned in claim 10 or a different terminal point of on one of the pair of tunnels. Examiner is interpreting it as the former.
Claim 15 recites the limitation "the lever plate" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15, the phrase “a plurality of holes formed through the lever mechanism along the rear portion of the lever plate” in lines 2-3 renders the claims indefinite because it is unclear in light of the 112(a) of claim 10 above. In light of the 112(a) of claim 10 above which discloses the terminal points are disposed on a rear portion of the lever mechanism, it becomes unclear what portion of the lever mechanism is considered “rear”. In para. 0017 and Fig. 2, the terminal points are designated as points 96 illustrated on a distal side of the lever plate 151. However, in Fig. 2 and 7 and para. 0020 stating “two pairs of holes 153, 154 formed at the rear of the plate 151” which is contradictory as these holes 153 and 154 are formed on the opposite side from the points 96. Examiner is interpreting this limitation as the pair of terminal points are locations for connection disposed symmetrically near the edge portion of the lever mechanism with the plurality of holes formed opposite the terminal points.
Regarding claim 15, the phrase “a first one of the pair of cable ends is coupled to a first one of the pair of guidewire legs adjacent the lever mechanism” in lines 4-5 and “wherein a second of the pair of cable ends is coupled to a second one of the pair of guidewire legs adjacent the lever mechanism” in lines 11-12 render the claim indefinite because they are unclear. It is unclear, in light of the 112(b) rejection of claim 10 discussed above with the terminal points, if the guidewire legs are connected at the pair of terminal points which are disposed on the lever mechanism then how is the cable being coupled to the guidewire legs adjacent the lever mechanism. Examiner is interpreting this limitation as the pair of terminal points are locations for connection disposed symmetrically on or adjacent the lever mechanism at some point in time during operation, wherein the pair of cable ends couple to the guidewire legs at the terminal points.
Regarding claim 15, the phrase “a cable… routed around the outside of a first one of the pair of semicircular vertical walls and through the corresponding one of the pair of tunnels… then back around the outside of a second one of the pair of semicircular vertical walls and through the corresponding one of the pair of tunnels” in lines 4-11 renders the claim indefinite because it is unclear. It is unclear, in light of the 112(a) rejection of claim 10 discussed above, whether the guidewire legs or the cable is what is routed around the semicircular walls and through the tunnels. Examiner is interpreting this limitation, in light of the specification, that the cable is what is routed around and through the respective structures with the guidewires being coupled thereto for corresponding movement.
Allowable Subject Matter
Claim 17 is allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is Yu et al. (U.S Patent Pub. No. 20180085558 A1, “Yu”), Mogul (U.S Patent Pub. No. 20170014600 A1), Hassoun (U.S Patent Pub. No. 20150305797 A1), and Kobayashi (W.O Patent Pub. No. 2013008490 A1).
Yu discloses a control handle (10 in Fig. 1-5) for a steerable catheter (14), the handle (10) comprising a housing (16, 18, 20 in Fig. 2), a catheter tube (14 in Fig. 2) affixed in the housing (16, 18, 20), see para. 0031), and a pair of guidewire legs (30, 32) extending from the proximal end of the catheter tube (14, see para. 0031). The handle (10) further comprises a lever mechanism (12 in Fig. 3-4) rotatably coupled to the housing (16, 18, 20) and having a lever arm (22 in Fig. 3-4) extending outside of the housing (16, 18, 20) and movable to rotate the lever mechanism (12, see para. 0031-0032). Further, Yu discloses a pair of terminal points (94) disposed symmetrically for connecting the pair of guidewire legs (30, 32, see para. 0030), a pair of posts (40 in Fig. 5) disposed symmetrically in the housing (16, 18, 20) positioned to provide inward tension to the guidewire legs (30, 32, see para. 0038), a pair of semicircular walls (42, 4 in Fig. 4) symmetrically disposed on the lever mechanism (12) each inset from the edge of the lever mechanism (12, see Fig. 4 and para. 0029-0030). However, Yu fails to disclose the enlarged knob portions on a leading edge of the semicircular walls and a pair of tunnels.
Mogul discloses a handle (see Fig. 4) for a steerable catheter comprising a lever mechanism (70) having a pair of walls (76, 78 in Fig. 4 and 7) that outwardly tension the guidewire in a similar manner to the instant invention (see para. 0031). Each of the walls (76, 78) comprises a knob portion (77, 79 in Fig. 4 and 7) formed at a leading edge of each wall (76, 78, see para. 0031). However, Mogul fails to disclose that the knob portions are enlarged knob portions.
Hassoun discloses an endoscopic instrument (100) having a control handle (122 in Fig. 8-9) formed of a ball (138) and socket (136) assembly that together function as a lever assembly when the arm (139) of the ball (138) is manipulated to pivot the ball (138) and thus the attached cables (108a, 108b) around a pair of semicircular walls of the socket (136, see para. 0032 and 0065). While Hassoun does teach that the semicircular walls formed the socket (136) comprises elevated portions (163 in Fig. 9) that protrude from the surface of the socket (136), the structure of the lever mechanism of Hassoun is significantly different than the control handle of instant invention with the elevated portions (163) being too different of a structure from the enlarged knob portions of the instant invention. Thus, the elevated portions (163) of Hassoun fail to disclose enlarged knob portions on semicircular walls.
Kobayashi discloses a catheter handle (1 in Fig. 3B) for a steerable catheter tube having two operation wires (31, 32 in Fig. 1) and a rotating plate (22 in Fig. 3B) having a plurality of symmetrical, vertically extending guide rails (231, 232, 233, 241, 242, 243 in Fig. 3B, see para. 0031). In operation, the guide rails (231 and 241 function as the pair of semicircular walls as they provide outward tension to the wires (31, 32) when the plate (22) is rotated with the outer rails (232, 242) forming a tunnel between them and the walls (231, 232) interpreted as the pair of tunnels formed adjacent said walls (231, 232) for routing the wires (31, 32, see para. 044). However, Kobayashi fails to disclose the tunnels being enclosed tunnels.
Therefore, there is no reference that teaches the knob portions having a smaller radius of curvature or the enclosed tunnels of claim 17.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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