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 .
Drawings
The drawings received on 5/18/2026 are acceptable and overcome the objections set forth in the last Office Action.
Specification
The amendments to the Specification received on 5/18/2026 are acceptable and overcome the objection set forth in the last Office Action.
Claim Rejections - 35 USC § 103
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 19, 21-23, 25-28, 30, 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Honebrink et al. (PG PUB 2012/0053569) in view of Mirarchi et al. (US Pat 5,562,619) and Poor et al. (US Pat 6,607,496), as evidenced by “PEBAX by Arkema, A polymer in Motion, Pebax elastomers” (claim 33 only).
Re claim 19, Honebrink discloses a steerable device (catheter body 100) configured to be advanced (push-pull wire 200, curving) in the lumen of a tubular element (catheter lumen 204) (see [0041], [0042], [0044], and Figures 1 and 2), said device comprising: a flexible axially elongated member having proximal and distal ends ((a) the deflectable distal end portion 102 of the catheter body 110, or (b) the catheter 202 of the catheter body 110; see [0041], [0044], and Figures 1 and 2), at least one actuating means (flexible element 200 in the form of a push-pull wire) arranged alongside the periphery of said elongated member ([0042, Fig. 2), at least one fastening means configured to fasten at least partially the at least one actuating means to the flexible elongated member distal end (connected by welding, adhesive, mechanical fasteners, etc., with (a) skirt-like anchors 220, 400A or (b) marker band 212), said fastening means being in direct contact with the at least one actuating means ([0046], [0050], Figure 2), at least one anti-return means configured to keep the at least one actuating means from sliding alongside the periphery of the flexible elongated member distal end ((1) the sealant 214 in FIG. 2 grips the skirt 220 and enables the transmission of the pushing and pulling force of the flexible element 200, so that the space for accommodating the skirt 220 of the sealant 214, or (2) the marker band 212 configured in FIG. 2, is crimped to the catheter 202; [0046], [0051], Figure 2), wherein the at least one anti-return means and the at least one fastening means are in axial abutting contact so as to prevent the at least one actuating means from sliding once actuated (all of the elements are secured together and abut one another; [0046], [0051], Figure 2).
Honebrink does not, however, describe that its wire 201, which is read on by the claim term "at least one actuating means," is made of a shape memory alloy configured to bend when actuated.
Both Mirarchi and Poor relate to pull wire steerable medical devices and are therefore from an art which is the same as, or very closely analogous to, those of Applicant's claims; in addition, they are representative of a large number of similar disclosures of the use of shape memory alloy materials, including NiTi alloys, for the pull wires of such devices, because of their superelasticity which greatly improves the safety and efficacy of the medical device because they are far less prone to rupture or become inelastically deformed in use.
It 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, to make Honebrink's wire 201, which is read on by the claim term "at least one actuating means," of a shape memory alloy configured to bend when actuated, because both Mirarchi and Poor teach doing so in closely related steerable medical devices, in order to improve the safety and functionality of the pull wire. Furthermore, the selection of a shape memory alloy, such as NiTi, is the mere substitution of equivalents known for the same purpose (see M.P.E.P. § 2144.06(II)), and the simple substitution of one known element for another to obtain predictable results (see M.P.E.P. § 2143(I)(B)), as evinced by Mirarchi and Poor.
Re claim 21, Honebrink discloses that the at least one actuating means comprises a spring or a wire (wire 201).
Re claim 22, Honebrink discloses that the at least one flexible axially elongated member is wire (tube 110 is shaped as a hollow wire) or blade shaped.
Re claim 23, Honebrink discloses that the flexible axially elongated member has a cross-section profile under a form (see treatment above) selected from star, circular (tube 110 has a circular cross-sectional profile), semicircular, square, rectangular, triangle, pyramidal or any combinations thereof.
Re claim 25, Honebrink discloses that the anti- return means is a tube (60), either glue filled or crimped (crimped, [0069]), the actuating means going through said tube (Fig. 6).
Re claim 26, Honebrink discloses a second anti-return means made integral with the flexible elongated member so as to maintain the fastening means in place (the second crimp 604 in Fig. 6 is a second anti-return means).
Re claim 27, Honebrink discloses that the anti-return means is a recess built into the flexible elongated member and configured to host the at least one fastening means (the space occupied by tube 600 is a recess in the encapsulant).
Re claim 28, Honebrink discloses that the anti-return means is made integral with the actuating means (as used in this application, "integral" includes a weld or one element clamped to another, see Claim 29; since the flexible element 200 in the form of a push-pull wire is connected to the marker band 212 by welding, adhesive, mechanical fastener, etc., regarding the connection portion, the non-return means - marker band 212 - is therefore integral with the operating means - flexible element 200).
Re claim 30, Honebrink discloses that the at least one anti-return means is a knot, a weld (a weld, see [0003], [0046]) or any local reinforcement located at the at least one actuating means distal end (id.).
Re claim 33, Honebrink discloses that the at least one actuating means is inside an electrically isolating material (Honebrink's encapsulant is PEBAX, see [0047]; Arkema discloses that PEBAX is an electrically isolating material) such as a tube or a coating (see treatment above).
Re claim 34, Honebrink discloses that the at least one actuating means is arranged alongside the external periphery of the elongated member (wire 201 is "alongside" the exterior surface of 110, 214, inasmuch as they are adjacent each other).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Honebrink et al. (PG PUB 2012/005359)/Mirarchi et al. (US Pat 5,562,619)/Poor et al. (US Pat 6,607,496) in view of Kaji et al. (US Pat 6,126,633).
Re claim 24, Honebrink, Mirarchi, and Poor together describe a device substantially as claimed by Applicant; they do not, however, disclose that its "fastening means" can be a ligation around the flexible elongated member. Kaji relates to pull wire steerable medical devices and are therefore from an art which is the same as, or very closely analogous to, those of Applicant's claims. Kaji teaches (Fig. 2 and col. 6, lines 1-13) that the pull wire (4) of a steerable catheter (1) can be secured to the catheter via a loop in a groove in the catheter (19), which secures the pull wire in place, and is therefore a ligation around the flexible elongated member, so that "the groove portion that is fixedly wound with the string 4 cannot axially slide with respect to the tube 2, so that the tube 2 can be bent in the manner indicated by broken line by pulling the string 4 to the handling side" (id.). It 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, to make Honebrink's "fastening means" as a ligation around the flexible elongated member, because Kaji teaches doing so in a closely related pull wire steerable catheter, for the foregoing reasons.
Response to Arguments
Applicant's arguments filed 5/18/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 10-11 of the Reply that one of ordinary skill in the art would not have achieved the actuating means of claim 19 by combining the teachings of Honebrink with the teachings of Mirarchi nor by combining the teachings of Honebrink with Poor. Throughout the arguments, Applicant argues the modification of Honebrink by Mirarchi alone and the modification of Honebrink by Poor alone, but does not argue what the combination of Mirarchi and Poor teach. As set forth in the rejection of claim 19 above, it is the combination of both Mirarchi and Poor that teach modifying Honebrink’s actuating means to be “made of a shape memory alloy configured to bend when actuated1”.
Regarding Mirarchi, Applicant argues that Mirarchi discloses shape memory alloys for their stretching capabilities only and not for a bending capability and, therefore, modifying Honebrink in view of Mirarchi would result in pull wire 201 being made of shape memory alloy but not result in pull wire 201 being configured to bend when actuated. The Examiner respectfully disagrees. Mirarchi disclose that the pull wire 54 (formed of nitinol) is crimped onto hypotube 56 (Col 5, Lines 55-56), Fig 4 shows the location of this crimping to be distal to electrode 44 in tip 47, Figs 2 and 3 show the bend to occur proximal to electrode 44, and Col 8, Lines 40-50 disclose that when the bend is formed as a result of pull wire being actuated by pushing distally on the thumbrest. Therefore, Mirarchi teaches a pull wire like Honebrink that is “made of a shape memory alloy configured to bend when actuated” as claimed.
Regarding Poor, Applicant argues that Poor discloses shape memory alloys only for their passive mechanical response to applied forces and does not disclose them for active shape change or bending via energization and, therefore, modifying Honebrink in view of Poor would only have obtained a device having a tip made of a superelastic material in order to sustain the repeated stresses of a bending resulting from a pull wire.
However, as set forth above, Poor is not used alone to teach the actuating means of claim 19. Rather, Poor teaches that using a shape memory alloy – like that of Mirarchi – ensures that a large bending deflection may be sustained without breakage (Col 2, Lines 26-34). Therefore, it would have been obvious to one of ordinary skill in the art to modify Mirarchi’s actuating means in view of Honebrink such that it is formed of shape memory alloy that is configured to bend when actuated because Poor teaches that using a shape memory alloy ensures that a large bending deflection may be sustained without breakage.
Therefore, the combination of Mirarchi’s teachings (subject matter) and Poor’s teachings (motivation) provide a prima facie case of obviousness to modify Honebrink.
Regarding Applicant’s argument on page 11 of the Reply that modification with Kaji would not achieve the actuating means of claim 19, this argument is moot because Kaji is only used in the rejection of claim 24 to teach providing a fastening means in the form of a ligation.
Regarding Applicant’s assertion on page 8 of the Reply that claims 35-36 should be acknowledged novel and inventive and satisfy the unity of invention criteria due to the “novel and inventive features of claim 19”, the Examiner respectfully disagrees since claim 19 has not been found to be novel and inventive for the reasons set forth above. If the subject matter of claim 19 is determined to be novel and inventive in the future, then claims 35 and 36 will be considered for rejoinder due to their dependence on claim 19.
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.
Please note that examination of this application has been reassigned from the previously named examiner to be the below named examiner. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571) 270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 It is noted that Applicant’s remarks appear to equate the actuation of claim 19 to “energizing” (e.g. via electrical, thermal or some other external stimulus) but the claims are not this narrow. Therefore, the actuation of claim 19 can be any form of actuation including physical and user-provided actuation.
Prosecution Insights