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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 4/10/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
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) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loschak et al. (6/12/23 IDS NPL cite No 3, “Loschak, Paul M., et al. "A 4-DOF robot for positioning ultrasound imaging catheters." ASME 2015 International Design Engineering Technical Conferences and Computers and Information in Engineering Conference. American Society of Mechanical Engineers Digital Collection, 2015.”, and hereinafter Loschak).
For claim 1, Loschak discloses a method for robotically operating a catheter (Figs 1-11) (Pgs 3-7), the method comprising inter alia:
connecting a robot to a shaft of a catheter spaced from a handle of the catheter (Figs 6-11) Pages 3-5, especially sections 4.2-4.5);
translating, by the robot at a location of the connection, the catheter along a longitudinal axis of the shaft (via translational transmission actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5); and
rotating, by the robot at the location of the connection, the shaft about the longitudinal axis (via rotational transmission actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5).
For claim 2, Loschak discloses the method of claim 1 wherein translating comprises operating a worm drive (translational transmission actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5), a worm (helical drive portion of translational transmission actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) of the worm drive connecting the robot to the shaft and a worm wheel (translational helical gear) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) of the worm drive connected to a motor (translational actuator(s)) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5).
For claim 3, Loschak discloses the method of claim 2 wherein translating comprises driving the worm along the longitudinal axis with a threaded connection to the worm wheel (helical based translation actuator) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5).
For claim 4, Loschak discloses the method of claim 1 wherein rotating comprises operating a worm drive (rotational transmission actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5), a worm (helical drive portion of rotational transmission actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) of the worm drive connecting the robot to the shaft and a worm wheel (rotational helical gears (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) of the worm drive connected to a motor (rotational actuator(s)) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5).
For claim 5, Loschak discloses the method of claim 4 wherein rotating comprises rotating the worm by rotation of the worm wheel, a tooth of the worm wheel positioned in a groove on the worm (rotation based translation actuator) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5).
For claim 6, Loschak discloses the method of claim 1 further comprising operating the catheter at the handle by the robot and wherein translating and rotating are additional operation of the catheter at the location (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5).
For claim 7, Loschak discloses a system for robotic manipulation of a catheter, the system comprising inter alia:
a handle robot (robot manipulator portion for last DOF for rotating handle, Pg 4 robot design section) configured to hold a handle of the catheter, the handle robot having one or more first gears to operate controls of the handle of the catheter (Pg 4 robot design section);
an access point robot (robot manipulator portion for translation DOF, robot manipulator portion for bending DOF for L/R pitch, and robot manipulator portion for other bending DOF for P/A yaw, Pg 4 robot design section) configured to hold a shaft of the catheter away from the handle, the access point robot configured to translate the shaft along a longitudinal axis of the catheter and to rotate the shaft about the longitudinal axis Pg 4 robot design section); and
a controller (computer terminal GUI, Pg 3) configured to control operation of the first gears, the translation, and the rotation (Pgs 3-4).
For claim 8, Loschak discloses the system of claim 7 wherein the access point robot comprises
a worm drive (rotational and translational transmission actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) having a worm (rotational and translational helical actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) with threading (threads of rotational and translational helical actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) and a notch (notches for rotational and translational of helical actuators/drives) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5),
a first worm wheel (translational helical gear) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) having threading (threading of the translation translational helical gear) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5), and
a second worm wheel (rotational helical gears (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) having a tooth (tooth of the rotational helical gear) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5) matable with the notch for the rotation (tooth of the rotational helical gear) (Figs 6-11) (Pages 3-5, especially sections 4.2-4.5).
Response to Arguments
Applicant's arguments, see pages 4-6, filed 4/10/26, with respect to the anticipatory rejection of the claims have been fully considered but they are not persuasive.
Applicant argues the following:
As described in the Applicants' specification, the claims are directed to robotic control where "translation and/or rotation manipulation is provided along the shaft or away from the handle, such as near a point of access to the patient." Para [0005]. In other words, the Application and claims provide where "dual manipulation (e.g., motion from two gripping points) provides for coupled manipulation. Fine, linear motion is provided by the robotic front mechanism connecting and operating near the insertion point of the shaft. High force and/or torque may be provided by using separate actuators for the translation and rotation. The fine motion is provided by linking the shaft of the catheter to the actuator through a worm gear with separate rotation and translation gear designs." Para [0032].
Claim 1, for example, recites "connecting a robot to a shaft of a catheter spaced from a handle of the catheter; translating, by the robot at a location of the connection, the catheter along a longitudinal axis of the shaft; and rotating, by the robot at the location of the connection, the shaft about the longitudinal axis.."
The cited reference Loschak does not disclose at least this limitation as Loschak does not disclose where the robot is connected to the shaft spaced from a handle of the catheter. Instead, Loschak explicitly teaches where the robot is connected to the handle of the catheter.
The Applicants' specification explicitly distinguishes the invention from prior art systems that operate exclusively at the catheter handle. For example, the "background" section of the specification identifies a key problem with existing systems: "Additionally, all motions are done at the handle, failing to account for the possibility of catheter buckling." In other words, the Application and claims solve a problem that is inherent in systems like the one described by Loschak, where the robot is "designed to mate with the handle" (Loschak, page 3). The "summary" and "detailed description" sections of the specification further solidify this distinction by repeatedly describing a "dual manipulation" system. This system includes a "handle robot" for manipulating the handle and a separate "access point robot" or "front mechanism." The specification states that this access point robot is "configured to hold a shaft of the catheter away from the handle" and is "placed around the flexible catheter body itself...near the insertion point in the patient." Para [0028]. The purpose of this access point robot is to provide "translation and/or rotation manipulation...along the shaft or away from the handle." Abstract. Further examples can be found in the Figures of the present Application, for example Figure 2 where the access point base is shown connected to the shaft spaced away from the handle.
Loschak does not teach this configuration or setup. Loschak describes a robotic system that explicitly connects to the catheter at the handle. For example, Loschak states the robot "was designed to mate with the handle" of the catheter (Loschak, page 3, Methods). It further describes the operational workflow where a clinician would "insert the catheter handle into the robot" (Loschak, page 5, paragraph 2). The figures cited in the rejection contradict its conclusion. Figure 6, for instance, clearly labels the "US Catheter Handle" and the "Catheter Handle Clamp" as the interface points between the catheter and the robotic system. The robotic actuators, such as the Pitch Driver, Yaw Driver, and Roll Driver, are all shown to engage with the handle and its integrated knobs, not with the shaft of the catheter. See also Figure 7.
While Loschak does disclose translating and rotating the catheter, these actions originate from the manipulation of the catheter's handle by the robot. Claim 1, however, requires that the translation and rotation occur "at a location of the connection," which is specified as being on the shaft and spaced from the handle. Since Loschak does not disclose this specific connection location, the reference fails to teach each and every limitation of the claims.
The Examiner respectfully notes in response the following:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “robotic control”, translation and/or rotation manipulation”, “along the shaft”, “near a point of access to the patient”, “patient”, “dual manipulation”, “motion from two gripping points”, “two gripping points”, “coupled manipulation”, “Fine, linear motion”, “robotic front mechanism”, “near the insertion point of the shaft”, “high force and/or torque, “separate actuators for the translation and rotation”, “fine motion is provided by linking the shaft of the catheter to the actuator through a worm gear”, “separate rotation and translation gear designs”, and/or “placed around the flexible catheter body itself…near the insertion point in the patient”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s argument that Loschak does not disclose "connecting a robot to a shaft of a catheter spaced from a handle of the catheter; translating, by the robot at a location of the connection, the catheter along a longitudinal axis of the shaft; and rotating, by the robot at the location of the connection, the shaft about the longitudinal axis.." or where the robot is connected to the shaft spaced from a handle of the catheter, the Examiner notes that Loschak’s disclosure may be fairly and reasonably considered to anticipate the claim limitation, especially as broadly as structurally claimed.
The claims merely requires the robot is connected to the catheter shaft and is “spaced from” the handle of the catheter. For example at least, Loschak’s Figs 6-8 and 11 may be fairly and reasonably interpreted to clearly disclose and evidentiarily demonstrate the translating/rotating robot connected to the catheter shaft and “spaced from” the catheter handle. The “spaced from” may be considered in the radial direction outwards (and/or inwards) from the robot or in the longitudinal direction lengthwise away from the robot. The handle and robot are not integrated nor are they monolithic. Furthermost, the catheter handle is “spaced from” the robot and shaft by at least Loschak’s catheter handle clamp. See annotation thereof further below.
In response to Applicant’s argument that Loschak does disclose translating and rotating the catheter "at a location of the connection" that is specified as being on the shaft and spaced from the handle, the Examiner note the positive recitation of the open-ended transitional phrase “comprising” that does not preclude additional unrecited elements. For example at least, the claims do not recite translating or rotating “by the robot at a location of the connection only to the shaft” or “connecting a robot only to a shaft of a catheter”. Similarly, the “spaced form a handle” is particularly broad and may read on both the smallest of distances existing between the robot, shaft, and/or handle or larger distances entirely. The claim does not recite “spaced entirely from entirety of the handle”, “disposed along the length of the catheter shaft at distinct and non-overlapping longitudinal positions”, or the like. Similarly, the Examiner notes that driving contact between a portion of Loschak’s catheter handle and the robot does not preclude a “spaced from a handle” relationship between the robot, catheter shaft and handle.
PNG
media_image1.png
781
465
media_image1.png
Greyscale
Conclusion
THIS ACTION IS MADE FINAL. 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 Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Prosecution Insights