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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/15/2026 has been entered.
Response to Arguments
Applicant's arguments filed 4/17/2026 have been fully considered but they are not persuasive.
Regarding the 102 rejection, Applicant argues that Grasse does not describe each and every element of the claim. Specifically, Applicant argues that Grasse does not disclose wherein the first catch has a first flexibility and the second catch has a second flexibility, the first flexibility being greater than the second flexibility. Applicant argues that Grasse does not disclose that the torque transfer mating structure are rigid nor describes the splines. This arguments is not convincing. While Grasse does not explicitly use these terms, it is clear from the disclosure and the figures how the device of Grasse operates and the examiner is using these terms for the sake of discussion. Fig. 5 of Grasse operates by the first catches located on the longitudinally extending elements (previously called “splines” by the examiner) engaging the second catches located on the inner member in order to resist relative rotation between the inner member and the outer member. The collar can be moved along the length of the outer member to adjust the inward force on the outer member and thereby adjust the holding force of the first catches on the second catches. The first catches are therefore necessarily more flexible than the second catches as the first catches flex outwardly by means of the splines whereas the second catch members are radially fixed around the outer surface of the inner member.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 17, 18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grasse et al (US 8,231,569).
Regarding claim 17, Grasse disclose a method for operating a medical device comprising, a. with a first catch 44 releasably gripping a second catch 46, and with the first catch coupled to a knob assembly 40 and the second catch coupled to a slide assembly 42 (fig. 4), applying torque to the knob assembly to rotated the knob assembly (col. 4, lines 62-67), wherein the first catch comprises a first set of spaced apart protrusions arranged axially around an axis of rotation and extending generally parallel to the axis of rotation (figs. 4, 5), the second catch comprises a second set of spaced apart protrusions arranged annularly around the axis of rotation and extending generally parallel to the axis of rotation (figs. 4, 5), and the protrusions of the first set of removably receivable between the protrusions of the second set (figs. 4, 5; col. 5, lines 1-5, 25-39), wherein the first catch has a first flexibility, and the second catch has a second flexibility, the first flexibility being greater than the second flexibility (fig. 5; col. 5, lines 25-39: first catches are flexible by way of flexible splines, second catches are fixed and non-flexible) b. transmitting rotation of the knob assembly to the first set of protrusions to force the first set of protrusions to rotate around the axis of rotation, and transmitting the rotation of the first set of protrusion to the second set of protrusions to force the second set of protrusions to rotate around the axis of rotation (col. 4, lines 52-57; col. 5, lines 25-39),.
Regarding claim 18, Grasse discloses the steps of c. increasing the torque applied to the knob to exceed a threshold value (col. 5, lines 1-5), and d. as a result of step c. , releasing the grip of the first catch on the second catch (col. 5, lines 1-5).
Regarding claim 20, the “slipping” of the protrusions relative to each other will necessarily produce a clicking sound thereby providing auditory feedback.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scheibe et al (US 9,149,607) in view of Grasse et al (US 8,231,569).
Regarding claim 1, Scheibe discloses a steerable medical device (fig. 1) comprising: a handle 12 having a rotatable knob assembly 44 and housing a slide assembly 42/48, wherein the knob assembly is couplable to the slide assembly to drive movement of the slide assembly by rotation of the knob assembly (fig. 2; col. 5, line 61 – col. 6, line 8); an elongate tool 40 extending from the handle; at least one control wire 58/68 coupled between the slide assembly and the tool (fig. 2; col. 4, lines 43-45), whereby movement of the slide assembly causes tensioning of the control wire, and tensioning of the control wire causes deflection of the tool (col. 5, line 61 – col. 5, line 8).
Claim 1 further calls for a first catch coupled to the knob assembly, and a second catch coupled to the slide assembly, whereby when torque applied to the knob assembly is below a threshold value, the first catch grips the second catch to drive movement of the slide assembly by rotation of the knob assembly, and whereby when torque applied to the knob assembly is above the threshold value, the first catch releases the grip on second catch to decouple the knob assembly from the slide assembly to avoid movement of the slide assembly by rotation of the knob assembly, wherein the first catch has a first flexibility and the second catch has a second flexibility, the first flexibility being greater than the second flexibility. Grasse teaches a handle for a catheter assembly, wherein the handle 16 includes first catch 44 coupled to the knob assembly 40 (figs. 3, 4, 5; col. 4, lines 48-49), and a second catch 46 coupled to a torque transfer assembly 42 (figs. 3, 4; col. 4, lines 50-52). The torque transfer assembly 40 of Grasse corresponds to the threaded screw 42 of Scheibe which is a portion of the slide assembly. Grasse further teaches that when torque applied to the knob assembly is below a threshold vale, the first catch grips the second catch to drive movement of the torque transfer assembly (col. 4, lines 62-67; col. 5, lines 25-39), and when torque applied to the knob assembly is above the threshold value, the first catch releases the grip on the second catch to decouple the knob assembly from the torque transfer assembly to avoid movement of the torque transfer assembly by rotation of the knob assembly (col. 5, lines 1-7. 25-39), wherein the first catch has a first flexibility, and the second catch has a second flexibility, the first flexibility being greater than the second flexibility (fig. 5; col. 5, lines 25-39: first catches are flexible by way of flexible splines, second catches are fixed and non-flexible). Grasse teaches that this mechanism can be used to decouple the knob assembly from pull wires above a torque threshold to avoid breaking pull wires via the application of excessive torques. Therefore, 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 handle of Scheibe to include a first catch coupled to the knob assembly and a second catch coupled to the slide assembly such that when torque is applied below a threshold, the first catch being more flexible than the second catch, the catch assemblies engaged to transmit rotation of the knob to the slide assembly, and when torque is applied above a threshold, the catch assemblies disengage to prevent excessive force applied to the pull wires which might cause breakage of the wires.
Regarding claim 2, Grasse further teaches that the first catch comprises a first set of spaced apart protrusions 44 arranged annularly around an axis of rotation and extending generally parallel to the axis of rotation (fig. 4); and the second catch comprises a second set of spaced apart protrusions 46 arranged annularly around the axis of rotation and extending generally parallel to the axis of rotation (fig. 4); wherein the protrusions of the first set are removably receivable between the protrusions of the second set (col. 4, line 63 – col. 5, line 8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the catch members as claimed in the combination described above with regard to claim 1 as taught by Grasse to provide the means to engage and disengage the knob from the slider and allow tension to be applied to the wires to steer the catheter while preventing excessive force that may break the wires.
Regarding claim 3, Scheibe in view of Grasse as discussed above with regard to claim 2 includes the first set of protrusions (elements 44 of Grasse) extending from a first hub (inner surface of the knob 44 of Scheibe), and the first hub is fixed to the knob assembly and rotatable with the knob assembly (the knob and the hub form a unitary structure); and the second set of protrusions (elements 46 of Grasse) extend from a second hub (portion of element 42 extending as a core into the knob 44 of Scheibe such that the knob of Scheibe has a cross section as shown in figs. 3 and 4 of Grasse), and the second hub is fixed to the slide assembly and rotatable with the slide assembly (second hub rotatable with screw 42 of Scheibe), and wherein the second hub comprises a shaft extending along the axis of rotation (shaft 42 shown in Grasse), and the shaft abuts the first hub (figs. 3, 4 of Grasse: the shaft is housed within the first hub). Therefore, the combination described above with regard to claims 1 and 2 include the structure as laid out in claim 3.
Regarding claim 4, in the combination described above with regard to claim 3, when torque applied to the knob assembly is below the threshold value, the protrusions of the first set are received between the protrusions of the second set to grip the second catch and thereby drive movement of the slide assembly by rotation of the knob assembly (Grasse: col. 4, lines 62-67).
Regarding claim 5, the combination described above with regard to claims 1-4 includes when torque applied to the knob assembly is above the threshold value, the protrusions of the first set deflect to clear the protrusions of the second set and release the grip of the first catch on the second catch and avoid movement of the slide assembly by rotation of the knob assembly (Grasse: fig. 5 – first protrusions deflect outwardly to clear second protrusions). 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 combination described above with regard to Scheibe in view of Grasse to include the first set of protrusions deflecting to clear the protrusions of the second set as taught by Grasse to allow the torque threshold to be controllable to a desired limit.
Regarding claim 6, Grasse further teaches that the protrusions deflect radially outwardly from the axis of rotation (fig. 5: outer protrusions deflect radially outwardly). 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 combination described above with regard to Scheibe in view of Grasse to include the first set of protrusions deflecting radially outwardly to clear the protrusions of the second set as taught by Grasse to allow the torque threshold to be controllable to a desired limit.
Regarding claim 7, Grasse further teaches the protrusions of the first set and the protrusions of the second set comprise inclined side surfaces, to facilitate deflection of the protrusions of the first set (col. 4, lines 56-57: sawtooth-like surfaces include engaging inclined surfaces). 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 protrusions of Scheibe in view of Grasse to further include inclined side surfaces as taught by Grasse to provide protrusions that can engage and disengage as needed.
Regarding claim 8, Grasse further teaches that the protrusions of the first set are in the form of resiliently flexible prongs (fig. 5: resiliently flexible prongs carry engaging protrusions), and the protrusions of the second set are in the form of inflexible bumps defining slots therebetween for receipt of the prongs (fig. 5: second set include bumps that engage protrusions on prongs).
Regarding claim 9, Scheibe discloses a handle 12 for a medical device (fig. 1) comprising: a rotatable knob assembly 44 and housing a slide assembly 42/48, wherein the knob assembly is couplable to the slide assembly to drive movement of the slide assembly by rotation of the knob assembly (fig. 2; col. 5, line 61 – col. 6, line 8).
Claim 9 further calls for a first catch coupled to the knob assembly, and a second catch coupled to the slide assembly, whereby when torque applied to the knob assembly is below a threshold value, the first catch grips the second catch to drive movement of the slide assembly by rotation of the knob assembly, and whereby when torque applied to the knob assembly is above the threshold value, the first catch releases the grip on second catch to decouple the knob assembly from the slide assembly to avoid movement of the slide assembly by rotation of the knob assembly. Grasse teaches a handle for a catheter assembly, wherein the handle 16 includes first catch 44 coupled to the knob assembly 40 (figs. 3, 4, 5; col. 4, lines 48-49), and a second catch 46 coupled to a torque transfer assembly 42 (figs. 3, 4; col. 4, lines 50-52), wherein the first catch has a first flexibility, and the second catch has a second flexibility, the first flexibility being greater than the second flexibility (fig. 5; col. 5, lines 25-39: first catches are flexible by way of flexible splines, second catches are fixed and non-flexible). The torque transfer assembly 40 of Grasse corresponds to the threaded screw 42 of Scheibe which is a portion of the slide assembly. Grasse further teaches that when torque applied to the knob assembly is below a threshold vale, the first catch grips the second catch to drive movement of the torque transfer assembly (col. 4, lines 62-67), and when torque applied to the knob assembly is above the threshold value, the first catch releases the grip on the second catch to decouple the knob assembly from the torque transfer assembly to avoid movement of the torque transfer assembly by rotation of the knob assembly (col. 5, lines 1-7). Grasse teaches that this mechanism can be used to decouple the knob assembly from pull wires above a torque threshold to avoid breaking pull wires via the application of excessive torques. Therefore, 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 handle of Scheibe to include a first catch coupled to the knob assembly and a second catch coupled to the slide assembly, the first catch being more flexible than the second catch, such that when torque is applied below a threshold, the catch assemblies engaged to transmit rotation of the knob to the slide assembly, and when torque is applied above a threshold, the catch assemblies disengage to prevent excessive force applied to the pull wires which might cause breakage of the wires.
Regarding claim 10, Grasse further teaches that the first catch comprises a first set of spaced apart protrusions 44 arranged annularly around an axis of rotation and extending generally parallel to the axis of rotation (fig. 4); and the second catch comprises a second set of spaced apart protrusions 46 arranged annularly around the axis of rotation and extending generally parallel to the axis of rotation (fig. 4); wherein the protrusions of the first set are removably receivable between the protrusions of the second set (col. 4, line 63 – col. 5, line 8). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the catch members as claimed in the combination described above with regard to claim 1 as taught by Grasse to provide the means to engage and disengage the knob from the slider and allow tension to be applied to the wires to steer the catheter while preventing excessive force that may break the wires.
Regarding claim 11, Grasse further teaches that the protrusions of the first set are in the form of resiliently flexible prongs (fig. 5: resiliently flexible prongs carry engaging protrusions), and the protrusions of the second set are in the form of inflexible bumps defining slots therebetween for receipt of the prongs (fig. 5: second set include bumps that engage protrusions on prongs).
Regarding claim 12, Scheibe in view of Grasse as discussed above with regard to claim 10 includes the first set of protrusions (elements 44 of Grasse) extending from a first hub (inner surface of the knob 44 of Scheibe), and the first hub is fixed to the knob assembly and rotatable with the knob assembly (the knob and the hub form a unitary structure); and the second set of protrusions (elements 46 of Grasse) extend from a second hub (portion of element 42 extending as a core into the knob 44 of Scheibe such that the knob of Scheibe has a cross section as shown in figs. 3 and 4 of Grasse), and the second hub is fixed to the slide assembly and rotatable with the slide assembly (second hub rotatable with screw 42 of Scheibe). Therefore, the combination described above with regard to claims 9 and 10 include the structure as laid out in claim 12.
Regarding claim 13, Scheibe in view of Grasse as applied to claim 12 above includes the second hub comprises a shaft extending along the axis of rotation (shaft 42 shown in Grasse), and the shaft abuts the first hub (figs. 3, 4 of Grasse: the shaft is housed within the first hub).
Regarding claim 14, in the combination described above with regard to claim 12, when torque applied to the knob assembly is below the threshold value, the protrusions of the first set are received between the protrusions of the second set to grip the second catch and thereby drive movement of the slide assembly by rotation of the knob assembly (Grasse: col. 4, lines 62-67).
Regarding claim 15, the combination described above with regard to claims 9-14 includes when torque applied to the knob assembly is above the threshold value, the protrusions of the first set deflect to clear the protrusions of the second set and release the grip of the first catch on the second catch and avoid movement of the slide assembly by rotation of the knob assembly (Grasse: fig. 5 – first protrusions deflect outwardly to clear second protrusions). 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 combination described above with regard to Scheibe in view of Grasse to include the first set of protrusions deflecting to clear the protrusions of the second set as taught by Grasse to allow the torque threshold to be controllable to a desired limit.
Regarding claim 16, Grasse further teaches the protrusions of the first set and the protrusions of the second set comprise inclined side surfaces, to facilitate deflection of the protrusions of the first set (col. 4, lines 56-57: sawtooth-like surfaces include engaging inclined surfaces). 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 protrusions of Scheibe in view of Grasse to further include inclined side surfaces as taught by Grasse to provide protrusions that can engage and disengage as needed.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grasse.
Regarding claim 18, Grasse discloses that when the torque is below the threshold, the first catches grip the second catches (col. 4, lines 58-67). Grasse does not explicitly teach the step of decreasing the torque applied, however, it is understood that in order to continue the procedure, the torque must be decreased to allow the torque to be applied to the device again. Additionally, the torque is necessarily decreased when the procedure concludes and the operator is no longer manipulating the device. Therefore, 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 method of Grasse to include the step of decreasing the torque after the threshold has been reached so that the device becomes operational again at a safe torque level to allow the procedure to be completed as desired, and also at the time of conclusion of the procedure when the user is no longer manipulating the device.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 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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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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