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 .
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
This Action is responsive to the Reply filed on 6 March 2026 (“Reply”). As directed in the Reply:
Claims 2 and 7 have been amended;
Claims 1 and 6 have been and/or remain cancelled; and
Claims 17 and 18 have been added.
Thus, Claims 2-5 and 7-18 are presently pending in this application, with Claims 3, 12, and 14 withdrawn from consideration. Applicant’s amendments to the drawings, Specification, and claims are effective to remove the bases for the previous objections thereto, and are therefore withdrawn.
Response to Arguments
Applicant’s arguments with respect to Claims 2, 4, 5, 7-11, 13, and 15-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Double Patenting
The terminal disclaimer filed on 6 March 2026, disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,344,702, has been reviewed and is accepted. The terminal disclaimer has been recorded and the prior double patenting rejection is withdrawn.
Claim Rejections - 35 USC § 103
Claims 2, 4, 5, 7, 9, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2003/0114832, by Kohler et al. (“Kohler”), optionally in view of U.S. Patent App. Pub. No. 2012/0078076, by Stewart et al. (previously of record, “Stewart”) or U.S. Patent No. 8,671,817, granted to Bogusky (“Bogusky”).
Kohler describes a device substantially as claimed by Applicant, as follows.
Claim 2: A steerable sheath (Fig. 1), comprising:
an elongate shaft (12) comprising a proximal portion (30), a distal portion (24), an intermediate portion disposed between the proximal and distal portions (28), and a lumen extending between the proximal and distal portions (36);
a first pull wire (46, 146) having a proximal end (in handle 18) and a distal end (in portion 28; see [0033], [0035]), wherein the distal end of the first pull wire is coupled to the intermediate portion of the elongate shaft (id.);
a second pull wire (42, 142) having a proximal end (in handle 18) and a distal end (in portion 24; see [0033], [0035]), wherein the distal end of the second pull wire is coupled to the distal portion of the elongate shaft (id.);
a handle coupled with the proximal portion of the elongate shaft (18);
a first actuator disposed on the handle (20; see [0033], [0035]); and
a second actuator disposed on the handle (also 20; see [0033], [0035]),
wherein the proximal end of the first pull wire is coupled to the first actuator (id.),
wherein the proximal end of the second pull wire is coupled to the second actuator (id.),
wherein actuation of the first actuator in a first direction tensions the first pull wire thereby forming a first proximal curve having a radius of curvature, and wherein actuation of the first actuator in a second direction opposite the first direction releases tension in the first pull wire thereby allowing the first proximal curve to return to an unbiased configuration (id.; moving actuator 20 back towards a neutral position releases tension in the wire), and
wherein actuation of the second actuator in a first direction tensions the second pull wire thereby forming a first distal curve having a radius of curvature, and wherein actuation of the second actuator in a second direction opposite the first direction of the second actuator releases tension in the second pull wire thereby allowing the first distal curve to return to an unbiased configuration (id.; moving actuator 20 back towards a neutral position releases tension in the wire).
Kohler does not, however, indicate the radii of curvatures of its two curves, and thus does not disclose that the radius of curvature of the first distal curve (“r(D)”) is smaller than the radius of curvature of the first proximal curve (“r(P)”). There are, however, only three possible combinations, because they are both scalars: r(D)= r(P); r(D)< r(P) (claimed); or r(D)> r(P).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the device of Kohler to have r(D)< r(P), since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, Kohler’s device would not operate differently with the claimed relative radii, because as illustrated in and described with reference to Figs. 8-10, the catheter would still be able to articulate and reach all the spaces it is intended to reach, e.g., a previously installed shunt, with simply a tighter bend in the distal flexible section, and therefore the device would function appropriately having the claimed relative radii. Further, Applicant assigns no criticality on the r(D)< r(P) claimed, indicating simply that, “[t]he distal curve has a smaller radius of curvature than the proximal curve” without indicating what purpose this serves, functions it promotes, or any other advantage that it may have over the two above-identified relationships (Specification @ [0027], [0028], and [0030]).
Alternatively, both Stewart and Bogusky relate to pull wire steerable catheters and their handles and are therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Stewart and Bogusky both teach that, for a steerable catheter having proximal and distal curves (with reference to AnnFig1 for Stewart, AnnFig2 for Bogusky, below, which are annotated versions of their Figs. 5 and 2A, respectively), that r(D)< r(P) can be selected in the design of the catheter so that:
the proximal curve can be used to anchor the catheter in the ascending aorta while the distalmost end can be positioned in the right coronary artery for delivering medicament or other devices (Bogusky Fig. 2A and accompanying text); and
it “provides a wide variety of optimal configurations for making firm contact with certain sites of ectopic foci, arrhythmia sustaining substrates or accessory pathways of interest in the heart” (Stewart Fig. 2-7 and accompanying text, [0016]).
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 construct Kohler’s catheter such that r(D)< r(P), because both Stewart and Bogusky teach doing so in a closely related, pull wire steered, dual curve catheter, for the foregoing reasons.
Claim 4: (The steerable sheath of claim 2,) wherein the first proximal curve is disposed in a first plane and the first distal curve is disposed in a second plane transverse to the first plane (Fig. 3 shows wires offset circumferentially by 90 degrees, resulting in the claimed orientation of the curve planes).
Claim 5: (The steerable sheath of claim 4,) wherein the first plane is orthogonal to the second plane (same).
Claim 7: (The steerable sheath of claim 2,) wherein actuation of the first pull wire and the second pull wire forms a first curve, and wherein further actuation of the first pull wire and the second pull wire form a second curve in a second position, and wherein actuation of the first and second pull wires forms a curve infinitely positionable between the first curve the second curve (based on a full reading of the underlying disclosure, the word “position” is understood to mean “configuration;” Kohler shows, Figs. 8-10, varying the configurations of the curves between first and second configurations).
Claim 9: (The steerable sheath of claim 2,) wherein the first actuator or the second actuator further comprises a locking mechanism configured to prevent unwanted movement of the respective first actuator or the second actuator ([0046]).
Claim 15: (The steerable sheath of claim 2,) further comprising:
a third pull wire having a proximal end and a distal end (150, 154), wherein the distal end of the third pull wire is coupled to the distal portion of the elongate shaft ([0035]);
a third actuator disposed on the handle, wherein the proximal end of the third pull wire is coupled to the third actuator ([0049], all pull wires have dedicated actuators 20 in handle 18),
wherein actuation of the third actuator in a first direction tensons the third pull wire thereby forming a second distal curve different than the first distal curve (wire 150 or 154 is fully capable of forming a distal curve defining an angle different from that of the first distal curve, by pulling more or less on the wire), and wherein actuation of the third pull wire in a second direction opposite the first direction of the third actuator releases tension in the third pull wire thereby allowing the second distal curve to return to an unbiased configuration (moving actuator 20 back towards a neutral position releases tension in the wire);
a fourth pull wire having a proximal end and a distal end (other of 150, 154), wherein the distal end of the fourth pull wire is coupled to the intermediate portion of the elongate shaft ([0035]); and
a fourth actuator disposed on the handle, wherein the proximal end of the fourth pull wire is coupled to the fourth actuator ([0049], all pull wires have dedicated actuators 20 in handle 18),
wherein actuation of the fourth actuator in a first direction tensions the fourth pull wire thereby forming a second proximal curve different than the first proximal curve (wire 150 or 154 is fully capable of forming a distal curve defining an angle different from that of the first distal curve, by pulling more or less on the wire), and wherein actuation of the fourth pull wire in a second direction opposite the first direction of the fourth actuator releases tension in the fourth pull wire thereby allowing the second proximal curve to return to an unbiased configuration (moving actuator 20 back towards a neutral position releases tension in the wire).
Claim 16: (Previously Presented) The steerable sheath of claim 2, further comprising:
a third pull wire having a proximal end and a distal end (150, 154), wherein the distal end of the third pull wire is coupled to the distal portion of the elongate shaft ([0035]); and
a third actuator disposed on the handle, wherein the proximal end of the third pull wire is coupled to the third actuator ([0049], all pull wires have dedicated actuators 20 in handle 18),
wherein actuation of the third actuator in a first direction tensions the third pull wire thereby forming a second distal curve different than the first distal curve (wire 150 or 154 is fully capable of forming a distal curve defining an angle different from that of the first distal curve, by pulling more or less on the wire), and wherein actuation of the third pull wire in a second direction opposite the first direction of the third actuator releases tension in the third pull wire thereby allowing the second distal curve to return to an unbiased configuration (moving actuator 20 back towards a neutral position releases tension in the wire), and
wherein simultaneous actuation of both the second actuator and the third actuator forms a curve in the elongate shaft that is infinitely positionable between the first distal curve and the second distal curve (as discussed above, pulling on the wires 144, 148, 152, and 156 different amounts results in curves of different configurations along a continuum).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kohler, optionally further in view of Stewart and/or Bogusky as applied to Claim 2 above, and further in view of U.S. Patent App. Pub. No. 2021/0022758, by Herlinger et al. (“Herlinger”).
Kohler, optionally further in view of Stewart and/or Bogusky, describes a device substantially as claimed by Applicant; see above. It/they does/do not, however, describe that the handle further comprises a window configured to allow an operator to visualize bubbles disposed therein (notably, the claim does not claim any liquid in the handle, and thus not any bubbles, either).
Herlinger relates to pull wire steerable catheters and their handles and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Herlinger teaches that the handle 26 of such a device can be made transparent ([0028]) so that the user can see the interior of the handle to monitor the status of its internal components, and thus comprises a window configured to allow an operator to visualize bubbles disposed therein (were there any there).
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 construct the handle of Kohler - Stewart - Bogusky’s device to include a window configured to allow an operator to visualize bubbles disposed therein, because Herlinger teaches constructing the handle of a closely related device to be transparent, in order to permit the user to see the interior of the handle during use.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kohler, optionally further in view of Stewart and/or Bogusky, as applied to Claim 2 above, and further in view of U.S. Patent App. Pub. No. 2016/0158497, by Tran et al. (“Tran”).
Kohler, optionally further in view of Stewart and/or Bogusky, describes a device substantially as claimed by Applicant; see above. It does not, however, describe that:
a distal portion of the first pull wire or the second pull wire is disposed along a first line, and wherein a proximal portion of the respective first pull wire or the second pull wire is disposed along a second line different than the first line (Claim 10); or
a distal portion of the first pull wire or the second pull wire is disposed along a first circumferential position of the elongate shaft, and wherein a proximal portion of the respective first pull wire or the second pull wire is disposed along a second circumferential position of the elongate shaft, the second circumferential position different than the first circumferential position (Claim 11).
Tran relates to pull wire steerable catheters and their handles and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Tran teaches (Figs. 6, 7; [0047]-[0049]) that the catheter can be designed so that the pull wires 104, 106 extend first along a linear path 108, then diverge at 112, 114, and then follow separate, linear paths 112, 114 toward the distal end of the catheter shaft, explaining that, “[t]his dual wire configuration allows the shaft 102 to have a primary flexing section (corresponding to the proximal section 118 of the steerable distal portion 116) and secondary flexing section (corresponding to the distal section 120 of the steerable distal portion 116).” Thus, Tran teaches the following features, for that reason:
a distal portion of the first pull wire or the second pull wire is disposed along a first line (distal linear portion of 112 or 114), and wherein a proximal portion of the respective first pull wire or the second pull wire is disposed along a second line different than the first line (108); and
a distal portion of the first pull wire or the second pull wire is disposed along a first circumferential position of the elongate shaft (112 or 114), and wherein a proximal portion of the respective first pull wire or the second pull wire is disposed along a second circumferential position of the elongate shaft (at 108), the second circumferential position different than the first circumferential position (because the lumen 108 splits into 112, 114, and is in the catheter wall, geometry requires them to be circumferentially offset from each other).
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 construct Kohler - Stewart - Bogusky’s pull wire steerable catheter with the additional features of Claims 10 and 11, because Tran teaches doing so in a closely related pull wire steerable catheter, in order to further provide multiple bending sections in the catheter.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kohler, optionally further in view of Stewart and/or Bogusky, as applied to Claim 2 above, and further in view of U.S. Patent App. Pub. No. 2015/0374890, by Lazarus (“Lazarus”).
Kohler, optionally further in view of Stewart and/or Bogusky, describes a device substantially as claimed by Applicant; see above. It does not, however, describe that it further comprises a variable stiffness dilator disposed in the sheath, wherein the variable stiffness dilator has a proximal portion, a distal portion, and an intermediate portion therebetween, wherein the intermediate portion is softer than the proximal portion or the distal portion, and wherein the softer intermediate portion permits steering of the sheath while the variable stiffness dilator is disposed therein.
Lazarus relates to pull wire steerable catheters and is therefore from an art which is the same as, or very closely analogous to, those of Applicant' s claims. Lazarus teaches that such a steerable catheter can be used, in order to make insertion of the catheter into the patient easier ([0047], [0054]), with a variable stiffness dilator (1100, variable stiffness because the proximal portion 1104, being larger, is stiffer than the narrower portions distal of shoulder 1102) disposed in the sheath ([0054]), wherein the variable stiffness dilator has a proximal portion (1104), a distal portion (adjacent end 1108), and an intermediate portion therebetween (smaller diameter portion between), wherein the intermediate portion is softer (understood to mean more flexible) than the proximal portion or the distal portion (the “or” meaning softer than one or the other; see explanation above concerning flexibility of the intermediate portion), and wherein the softer intermediate portion permits steering of the sheath while the variable stiffness dilator is disposed therein (the sheath and dilator can be steered by hand by moving handle 1110; the claim does not state, and thus not require, steering by bending the sheath by tensioning one or more pull wires).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to provide the device of Kohler - Stewart - Bogusky with a dilator as stated in Claim 13, because Lazarus teaches doing so in a closely related catheter, to make it easier to insert the catheter into the patient.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kohler, optionally further in view of Stewart and/or Bogusky.
Kohler, optionally further in view of Stewart and/or Bogusky, describes a device substantially as claimed by Applicant; see above. It/they does/do not, however, describe that the distal portion has length of 2-4 cm long, and the intermediate portion has a length of 4-10 cm long; Kohler does, however, describe that, “[f]or use of catheter 10 to access sites within a patient's heart, length of mid segment 26 is preferably in the range of 1 to 9 centimeters. Similarly, for use of catheter 10 to access sites within a patient's heart, length of distal segment 22 is preferably in the range of 0.5 to 3 centimeters” ([0040]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to construct the device of Kohler - Stewart - Bogusky so that the distal portion has length of 2-4 cm long, and the intermediate portion has a length of 4-10 cm long, since it has been held that, “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 1345 (Fed. Cir. 1984), cert. denied, 469 U.S. 830 (1984); see also In re Chu, 66 F.3d 292, 298-99 (Fed. Cir. 1995) (“design choice” is appropriate where the applicant fails to set forth any reasons why the differences between the claimed invention and the prior art would result in a different function). In the instant case, Kohler- Stewart - Bogusky’s device would not operate differently with the claimed portion lengths, because Kohler expressly describes the adjacent portions of its catheter to have similar lengths, and as such the catheter would still be able to articulate and reach all the spaces it is intended to reach, e.g., a previously installed shunt, and therefore the device would function appropriately having the claimed portion lengths. Further, Applicant assigns no criticality on the portion lengths, indicating simply that:
In any example of steerable sheath disclosed herein, the proximal portion and distal portions of the elongate shaft of the steerable sheath may have any desired length and this maybe based on the procedure being performed or the anatomy. For example, the distal portion of a steerable sheath may have a distal portion where the distal curve is formed, and the distal portion may be the distal-most 2-4 centimeters of the elongate shaft. Similarly, the intermediate portion of the elongate shaft where the proximal curve is formed maybe be the next 4-10 centimeters of the elongate shat that are proximal of the distal portion.
(Specification @ [0069]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Kohler in view of Bogusky, optionally further in view of Stewart.
Kohler, optionally further in view of Stewart and/or Bogusky, describes a device substantially as claimed by Applicant; see above. Additionally, Kohler describes that its catheter further comprises a transitional segment (26) between the distal portion and the intermediate portion (Fig. 1), wherein the transitional segment is stiffer than the intermediate portion ([0032]: “Bending portions 24 and 28 are made of a similar material with a lower durometer than segments 22, 26 and 30, meaning pending portions 24 and 28 are more easily bent, while segments 22, 26 and 30 are relatively more rigid. Bending portions 24 and 28 may be made of material of the same durometer, alternatively, first bending portion 24 may be made of a lower durometer material than second bending portion 28.”),
Kohler, optionally further in view of Stewart and/or Bogusky, does not describe that the transitional segment is less stiff than the proximal portion, thereby facilitating smoother tracking of the elongate shaft and helping to prevent kinking thereof.
Bogusky describes that, when constructing a pull wire steerable catheter having distal (114), transitional (116), and proximal (120) portions, that the transitional portion can be made more less stiff than the proximal portion so that the catheter’s stiffness strikes a balance between pushability and flexibility (col. 15, lines 16-20), to better traverse a patient’s vasculature (col. 14, lines 1-7).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to construct the device of Kohler - Stewart - Bogusky so that the transitional segment is less stiff than the proximal portion, because Bogusky teaches doing so in a closely related catheter, to strike a balance between the catheter’s pushability and flexibility, to better traverse a patient’s vasculature.
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 Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783