DETAILED ACTION
Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species A, Fig. 1-4D, in the reply filed on 06/23/2026 is acknowledged.
Claim Rejections - 35 USC § 112
Claims 14-15 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. Claim 14 presents the limitation “the knob is configured to: grossly deflect the distal part of the catheter by the threaded mechanism functioning as a linear actuator, and finely deflect the distal part of the catheter by the threaded mechanism not functioning as a linear actuator.” Such describes a configuration which is opposite to that described and depicted within the applicant(s) specification. The specification consistently describes that the threaded mechanism functions as a linear actuator only upon rotation of the knob (see [0012], [0048], and [0058-0059]). However, it is further clear from the specification that rotation of the knob results in fine deflection of the distal part of the catheter, not gross deflection. No opposite configuration (in which rotation of the knob would result in gross deflection) is presented within the application. The cited claim limitation of claim 14 thus directly conflicts with the configuration disclosed within the specification, thereby claims 14 and 15 (dependent upon claim 14) 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. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-13 and 16-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nitzsche (U.S. Pat. Pub. No. 5,190,050).
Regarding claim 1, Nitzsche discloses an apparatus (steerable catheter assembly comprising handle 2 and catheter 44) comprising a catheter assembly that comprises: a catheter (catheter tube 44); a handle (handle 2), disposed at a proximal part of the catheter (see Fig. 1-4 and Col. 5, ln 34-49); a pull wire (lower pull cable 48), extending from a distal part of the catheter (the lower pull cable 48 being soldered to the lower shim 70, which is disposed at the distal tip 54 of the catheter – see Fig. 2-4 and Col. 7, ln 7-45), proximally through the catheter to the handle (see Fig. 2-4 and Col. 5, ln 50-55); and a control handle assembly (assembly of base cylinder 22, collar sleeve 28, lever 30, o-ring 34, and end collar 38), disposed at the handle (see Fig. 2 and Col. 4, ln 33 – Col. 5, ln 33), and configured to be operated: in a gross-tensioning manner that grossly adjusts tension on the pull wire (Col. 7, ln 58 – Col. 8, ln 50, wherein the collar sleeve 28 may be axially translated in the distal direction 72 by a pushing force of the user without rotation of the collar sleeve, causing the lever 30 to be pushed out of engagement with rachet threads 16 of the handle, in order to thereby axially translate in a gross manner the entire catheter tube assembly 44 axially, thereby grossly adjusting tension on the lower pull cable 48, which is held fixed to the handle at its proximal end but is also fixed to the distal end of the catheter at lower shim 70), and in a fine-tensioning manner that finely adjusts the tension on the pull wire (Col. 8, ln 50-62, wherein the collar sleeve 28 may be rotated while the lever 30 is engaged with the rachet threads 16 of the handle to thereby axially translate in a fine manner the entire catheter tube assembly 44 axially, thereby finely adjusting tension on the lower pull cable 48, which is held fixed to the handle at its proximal end but is also fixed to the distal end of the catheter at lower shim 70).
Regarding claim 2, Nitzsche further discloses that the pull wire is coupled to the catheter such that adjusting the tension in the pull wire adjusts a curvature of the distal part of the catheter (see Fig. 3 and Col. 8, ln 9-50).
Regarding claim 3, Nitzsche further discloses that the control handle assembly comprises a knob (collar sleeve 28) that is mounted such that the gross-tensioning manner includes sliding of the knob axially with respect to the handle without rotation of the knob (Col. 7, ln 58 – Col. 8, ln 50, wherein the collar sleeve 28 may be axially translated in the distal direction 72 by a pushing force of the user without rotation of the collar sleeve, causing the lever 30 to be pushed out of engagement with rachet threads 16 of the handle, in order to thereby grossly adjusting tension on the lower pull cable 48 in the manner explained in re claim 1 and in the cited text).
Regarding claim 4, Nitzsche further discloses that the knob is collinear with the handle (see Fig. 1-4 and Col. 4, ln 49-57, wherein collar sleeve 28 is mounted collinearly to the handle).
Regarding claim 5, Nitzsche further discloses that the mounting of the knob is such that: sliding of the knob axially in a first axial direction (distal direction 72) with respect to the handle without rotation of the knob grossly increases the tension in the pull wire (Col. 7, ln 58 – Col. 8, ln 50, wherein the collar sleeve 28 may be axially translated in the distal direction 72 by a pushing force of the user without rotation of the collar sleeve, causing the lever 30 to be pushed out of engagement with rachet threads 16 of the handle, in order to thereby increase the tension in the lower pull cable 48 in the manner explained in re claim 1 and in the cited text); and sliding of the knob axially in a second axial direction (proximal direction) with respect to the handle without rotation of the knob grossly reduces the tension in the pull wire, the second axial direction being opposite to the first axial direction (Col. 8, ln 63 – Col. 9, ln 8).
Regarding claim 6, Nitzsche further discloses that the mounting of the knob is such that sliding of the knob axially in the first axial direction with respect to the handle comprises sliding of the knob distally away from the handle in the first axial direction (in the distal direction 72, see Fig. 2-4 and Col. 7, ln 58 – Col. 8, ln 50).
Regarding claim 7, Nitzsche further discloses that the mounting of the knob is such that the fine-tensioning manner includes rotation of the knob with respect to the handle (Col. 8, ln 50-62 and Col. 9, ln 9-11).
Regarding claim 8, Nitzsche further discloses that the mounting of the knob is such that: rotation of the knob in a first rotational direction with respect to the handle finely increases the tension in the pull wire (Col. 8, ln 50-62, wherein when collar sleeve 28 is rotated in one axial direction and lever 30 is allowed to engage the helical rachet thread 16, the collar sleeve is thereby gradually driven axially distally by the engagement of the tooth 32 of the lever 30 which rides the helical rachet thread 16), and rotation of the knob in a second rotational direction with respect to the handle finely reduces the tension in the pull wire, the second rotational direction being opposite to the first rotational direction (Col. 9, ln 9-11, wherein by virtue of the fact that the rachet thread 16 is helical, and the tooth 32 of the lever 30 rides along the helical thread to axially translate the collar sleeve 28, it follows that a reversal of the direction of rotation of the collar sleeve as compared to the first rotational direction must necessarily result in axial translation of the collar sleeve in the opposite, proximal direction).
Regarding claim 9, Nitzsche further discloses that the control handle assembly comprises (i) a knob (collar sleeve 28), and (ii) a threaded mechanism (rachet threading 16) that provides operative coupling between the knob and the handle (see Fig. 2 and Col. 4, ln 49 – Col. 5, ln 22), and is configured to be operated: in the fine-tensioning manner by the threaded mechanism functioning as a linear actuator (Col. 8, ln 50-62, wherein when collar sleeve 28 is rotated in one axial direction and lever 30 is allowed to engage the helical rachet thread 16, the collar sleeve is thereby gradually driven axially distally in the manner of a linear actuator by the engagement of the tooth 32 of the lever 30 which rides the helical rachet thread 16, thereby finely adjusting the tension on the lower pull cable 48 in the manner discussed in re claim 1 and in the cited text), and in the gross-tensioning manner by the threaded mechanism not functioning as a linear actuator (Col. 7, ln 58 – Col. 8, ln 50, wherein the collar sleeve 28 may be axially translated in the distal direction 72 by a pushing force of the user without rotation of the collar sleeve, causing the lever 30 to be pushed out of engagement with rachet threads 16 of the handle, in order to thereby grossly adjust the tension the lower pull cable 48 in the manner discussed in re claim 1 and the cited text).
Regarding claim 10, Nitzsche further discloses that the threaded mechanism is configured such that operation of the control handle assembly in the gross-tensioning manner includes transient disengagement of the threaded mechanism (riding up/disengagement of lever 30 from the rachet thread 16 – see Fig. 2, Col. 4, ln 59 – Col. 5, ln 22, and Col. 8, ln 34-50).
Regarding claim 11, Nitzsche discloses an apparatus comprising a catheter assembly (steerable catheter assembly comprising handle 2 and catheter 44) that comprises: a catheter (catheter tube 44); a handle (handle 2), disposed at a proximal part of the catheter (see Fig. 1-4 and Col. 5, ln 34-49); and a knob (collar sleeve 28), disposed at the handle (see Fig. 2 and Col. 4, ln 49 – Col. 5, ln 22), operatively coupled to a distal part of the catheter (see Fig. 2 and Col. 4, ln 49 – Col. 5, ln 22), and configured to: grossly deflect the distal part of the catheter responsively to being moved in an axial, non-rotational manner (Col. 7, ln 58 – Col. 8, ln 50, wherein the collar sleeve 28 may be axially translated in the distal direction 72 by a pushing force of the user without rotation of the collar sleeve, causing the lever 30 to be pushed out of engagement with rachet threads 16 of the handle, in order to thereby grossly adjusting tension on the lower pull cable 48 in the manner explained in re claim 1 and in the cited text), and finely deflect the distal part of the catheter responsively to being rotated (Col. 8, ln 50-62, wherein the collar sleeve 28 may be rotated while the lever 30 is engaged with the rachet threads 16 of the handle to thereby finely adjust tension on the lower pull cable 48 in the manner explained in re claim 1 and the cited text).
Regarding claim 12, Nitzsche further discloses that the catheter assembly comprises a wire (lower pull cable 48) that is coupled to the catheter (the lower pull cable 48 being soldered to the lower shim 70, which is coupled to the catheter at the distal tip 54 of the catheter – see Fig. 2-4 and Col. 7, ln 7-45), the knob being configured to: grossly deflect the distal part of the catheter by grossly adjusting tension in the wire (see Fig. 3 and Col. 8, ln 9-50), and finely deflect the distal part of the catheter by finely adjusting the tension in the wire (Fig. 3 and Col. 8, ln 50-62).
Regarding claim 13, Nitzsche further discloses that the knob is collinear with the handle (see Fig. 1-4 and Col. 4, ln 49-57, wherein collar sleeve 28 is mounted collinearly to the handle).
Regarding claim 16, Nitzsche discloses an apparatus (steerable catheter assembly comprising handle 2 and catheter 44) comprising a catheter assembly that comprises: a catheter (catheter tube 44); a handle (handle 2), disposed at a proximal part of the catheter (see Fig. 1-4 and Col. 5, ln 34-49); a pull wire (lower pull cable 48), extending from a distal part of the catheter (the lower pull cable 48 being soldered to the lower shim 70, which is disposed at the distal tip 54 of the catheter – see Fig. 2-4 and Col. 7, ln 7-45), proximally through the catheter to the handle (see Fig. 2-4 and Col. 5, ln 50-55); and a control handle assembly (assembly of base cylinder 22, collar sleeve 28, lever 30, o-ring 34, and end collar 38), disposed at the handle (see Fig. 2 and Col. 4, ln 33 – Col. 5, ln 33), and configured to be operated: in a gross-tensioning manner that grossly reshapes the distal part of the catheter (Col. 7, ln 58 – Col. 8, ln 50, wherein the collar sleeve 28 may be axially translated in the distal direction 72 by a pushing force of the user without rotation of the collar sleeve, causing the lever 30 to be pushed out of engagement with rachet threads 16 of the handle, in order to thereby axially translate in a gross manner the entire catheter tube assembly 44 axially, thereby grossly adjusting tension on the lower pull cable 48, which is held fixed to the handle at its proximal end but is also fixed to the distal end of the catheter at lower shim 70, causing the distal part of the catheter to grossly deflect or straighten, depending upon whether tension is increased or reduced), and in a fine-tensioning manner that finely reshapes the distal part of the catheter (Col. 8, ln 50-62, wherein the collar sleeve 28 may be rotated while the lever 30 is engaged with the rachet threads 16 of the handle to thereby axially translate in a fine manner the entire catheter tube assembly 44 axially, thereby finely adjusting tension on the lower pull cable 48, which is held fixed to the handle at its proximal end but is also fixed to the distal end of the catheter at lower shim 70, causing the distal part of the catheter to finely deflect or straighten, depending upon whether tension is increased or reduced).
Regarding claim 17, Nitzsche further discloses that the pull wire is coupled to the catheter (the lower pull cable 48 being soldered to the lower shim 70, which is coupled to the catheter at the distal tip 54 of the catheter – see Fig. 2-4 and Col. 7, ln 7-45), and the control handle assembly is configured to: grossly reshape the distal part of the catheter by grossly adjusting tension in the pull wire (see in re claim 16), and finely reshape the distal part of the catheter by finely adjusting the tension in the pull wire (see in re claim 16).
Regarding claim 18, Nitzsche further discloses that the control handle assembly comprises a knob (collar sleeve 28) that is mounted such that the gross-tensioning manner includes sliding of the knob axially with respect to the handle without rotation of the knob (Col. 7, ln 58 – Col. 8, ln 50, wherein the collar sleeve 28 may be axially translated in the distal direction 72 by a pushing force of the user without rotation of the collar sleeve, causing the lever 30 to be pushed out of engagement with rachet threads 16 of the handle, in order to thereby grossly adjusting tension on the lower pull cable 48 in the manner explained in re claim 1 and in the cited text).
Regarding claim 19, Nitzsche further discloses that the mounting of the knob is such that the fine-tensioning manner includes rotation of the knob with respect to the handle (Col. 8, ln 50-62, wherein the collar sleeve 28 may be rotated while the lever 30 is engaged with the rachet threads 16 of the handle to thereby finely adjust tension on the lower pull cable 48 in the manner explained in re claim 1 and the cited text).
Regarding claim 20, Nitzsche further discloses that the control handle assembly comprises a threaded mechanism (rachet threading 16) that provides operative coupling between the knob and the handle (see Fig. 2 and Col. 4, ln 49 – Col. 5, ln 22), and is configured to be operated: in the fine-tensioning manner by the threaded mechanism functioning as a linear actuator (Col. 8, ln 50-62, wherein when collar sleeve 28 is rotated in one axial direction and lever 30 is allowed to engage the helical rachet thread 16, the collar sleeve is thereby gradually driven axially distally in the manner of a linear actuator by the engagement of the tooth 32 of the lever 30 which rides the helical rachet thread 16, thereby finely adjusting the tension on the lower pull cable 48 in the manner discussed in re claim 1 and in the cited text), and in the gross-tensioning manner by the threaded mechanism not functioning as a linear actuator (Col. 7, ln 58 – Col. 8, ln 50, wherein the collar sleeve 28 may be axially translated in the distal direction 72 by a pushing force of the user without rotation of the collar sleeve, causing the lever 30 to be pushed out of engagement with rachet threads 16 of the handle, in order to thereby grossly adjust the tension the lower pull cable 48 in the manner discussed in re claim 1 and the cited text).
Regarding claim 21, Nitzsche further discloses that the threaded mechanism is configured to facilitate operation in the gross-tensioning manner by allowing non-rotational axial movement of the knob with respect to the handle via transient disengagement of the threaded mechanism upon application of a non-rotational axial force to the knob (riding up/disengagement of lever 30 from the rachet thread 16 – see Fig. 2, Col. 4, ln 59 – Col. 5, ln 22, and Col. 8, ln 34-50).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. This art includes
Murray (U.S. Pat. Pub. No. 2012/0310332 A1) exhibits a catheter assembly wherein an extension/retraction of a sheath of the catheter may be finely or grossly adjusted from the handle via a control mechanism similar to that claimed.
Avitall (U.S. Pat. No. 5,441,483) exhibits a steerable catheter assembly similar to that claimed, wherein a pull wire is provided and the tension of said pull wire may be adjusted either in a gross manner (as in the configuration of Fig. 1A-5B) or a fine/gradual manner (as in the configuration of Fig. 6A-6D).
Lundquist (U.S. Pat. No. 5,195,968) exhibits a steerable catheter assembly similar to that claimed, wherein a pull wire is provided and the tension of said pull wire may be adjusted by the rotation of a knob (see embodiment of Fig. 7-10 and knobs 530 and 540).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric A Lange whose telephone number is (571)272-9202. The examiner can normally be reached on M-F 8:30am-noon and 1pm-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached on (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC A LANGE/Examiner, Art Unit 3783
/CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights