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 .
Effective Filing Date
The filing date for the application is 11/30/2023. However, it claims priority to provisional application 63/429,502 filed on 12/01/2022, which appears to reasonably provide written description support for the pending claims, so that filing date of the provisional application is the effective filing date being given to the current claims (12/01/2022).
Information Disclosure Statement
The Applicant has submitted an information disclosure statement (IDS) which is 38 pages long that includes 17 pages of US Patent or Pre-Grant Publications followed by a list of 94 Foreign references and 35 Non-Patent Literature (NPL) references, likely totaling thousands upon thousands of pages to potentially review. In accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), stating that forcing the Examiner to find "a needle in a haystack" is "probative of bad faith." Id. [The Molins] case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Likewise, the instant application’s IDS includes way more than even what was found to be excessive in the Molins case, and this IDS does not include any concise explanation of the relevance of any of the listed references nor cite any pages, columns, and lines (or paragraph numbers) where relevant passages or relevant figures appear. According to MPEP Section 2004 “Aids to Compliance With Duty of Disclosure [R-08.2012]”, “It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of most significance.” Additionally, per MPEP Section 609.04(a)(III): “applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.” See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v.Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
As such, even though this IDS has been placed in the application file with the list of references marked as considered, and the compilation of those listed US Patents and Pre-Grant Publications have at least been key-word searched and/or classification searched for relevant prior art, and the compilation of foreign and/or NPL references have at least been briefly reviewed (for example, abstracts and drawings reviewed), the information referred to therein for each individual reference has admittedly been considered only within the reasonable time period allocated by the Examiner out of the total normal examination time given for any given application with a similar classification picture. If Applicant wishes to have one or more references considered more in depth, the Examiner requests resubmitting the IDS with a reasonable number of references that are known to be pertinent for the determination of patentability as defined by 37 C.F.R. § 1.56, along with the concise explanations as to relevance and citations explaining the locations of relevant passages or figures, as per 37 CFR 1.98(a)(3) and 37 CFR § 1.105.
Joint Inventors
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The term “degree” in claim 16 is a relative term which renders the claim indefinite. The term “degree” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1 – 4, 6 – 9, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Swoyer et al. (US Pub No: 2024/0138946 A1, hereinafter Swoyer) in view of Schorr et al. (US Pub No: 2026/0041414 A1, hereinafter Schorr) and Chookhachizadehmoghadam (US Pub No: 2025/0099089 A1, hereinafter Chook).
Regarding Claim 1:
Swoyer discloses:
A robotic interventional device control system comprising: an interventional device. Paragraph [0081] describes a robotic catheter cradle 135.
a controller configured to control axial movement of the interventional device along a drive table. Paragraph [0081] describes a robotic catheter cradle 135 coupled to a table cart. The controller adjusts motion of the catheter, such as axially.
a sensor system configured to detect axial movement of the interventional device along the drive table. Paragraph [0061] describes a processor that has an operator feedback module 385 that is coupled to a human-machine interface 155 to generate response signals.
one or more hardware processors configured to receive motion data from the sensor system, the motion data indicative of whether the interventional device is axially moving along the drive table. Paragraph [0061] describes a processor that has an operator feedback module 385 that is coupled to a human-machine interface 155 to generate response signals.
wherein the one or more hardware processors are further configured to, based on the motion data, generate a user interface comprising an instrument window, the instrument window comprising. Paragraph [0050] describes a human-machine interface 155 that includes visual feedback, such as a display screen.
Swoyer does not disclose a representation of the interventional device.
Schorr, in an analogous field of endeavor, teaches:
a representation of the interventional device. Paragraph [0033] describes a display system that can display the flexible catheter generated by the sensor system.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Swoyer to incorporate the teachings of Schorr to show a representation of the interventional device. One would have been motivated to do so that the operation can control the medical instrument and master assembly via telepresence ([0033] of Schorr).
Swoyer does not disclose changing the interventional device to transition from a first to a second configuration.
Chook, in an analogous field of endeavor, teaches:
and an interventional device marker associated with the representation of the interventional device, the interventional device marker configured to transition from a first configuration to a second configuration when the interventional device is moving axially along the drive table; and a display configured to display the user interface. Paragraph [0150] describes a catheter with a first and second configuration based on the tendon to the elongated tube 103.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Swoyer to incorporate the teachings of Chook to show changing the interventional device to transition from a first to a second configuration. One would have been motivated to do so that the deformation of the catheter can be measured ([0150] of Chook).
Regarding Claim 2:
Schorr teaches:
The robotic interventional device control system of Claim 1, wherein the instrument window further comprises a speed indicator configured to indicate a speed at which the interventional device is configured to move in a distal direction or a proximal direction. Paragraph [0032] describes determining a speed/velocity of a distal portion of the flexible catheter.
The reason to combine Schorr with Swoyer is for the same reason as in claim 1.
Regarding Claim 3:
Schorr teaches:
The robotic interventional device control system of Claim 1, wherein the representation of the interventional device extends along a central longitudinal axis. Paragraph [0069] describes a instrument interface as it moves along the longitudinal central axis.
The reason to combine Schorr with Swoyer is for the same reason as in claim 1.
Regarding Claim 4:
Chook teaches:
The robotic interventional device control system of Claim 3, wherein in the firs configuration, the interventional device marker is in a first position, and wherein in the second configuration, the interventional device marker is in second position. Paragraph [0150] describes a catheter with a first and second configuration based on the tendon to the elongated tube 103.
The reason to combine Chook with Swoyer is for the same reason as in claim 1.
Regarding Claim 6:
Swoyer discloses:
The robotic interventional device control system of Claim 1, wherein the interventional device marker is configured to be in the first configuration when the interventional device is not moving axially along the drive table. Paragraph [0081] describes a robotic catheter cradle 135 coupled to a table cart. The controller adjusts motion of the catheter, such as axially, deflection and/or rotational motion.
Regarding Claim 7:
Schorr teaches:
The robotic interventional device control system of Claim 1, wherein the representation of the interventional device includes a visual indication of a distal end of the interventional device. Paragraph [0033] describes a display system that can display the flexible catheter generated by the sensor system.
The reason to combine Schorr with Swoyer is for the same reason as in claim 1.
Regarding Claim 8:
Chook teaches:
The robotic interventional device control system of Claim 7, wherein the visual indication corresponds to a shape of the distal end of the interventional device. Paragraph [0026] describes a catheter being able to deform its shape because it is made of a shape memory alloy.
The reason to combine Chook with Swoyer is for the same reasons as in claim 1.
Regarding Claim 9:
Chook teaches:
The robotic interventional device control system of Claim 1, wherein the representation of the interventional device comprises a shape corresponding to a shape of a portion of the interventional device. Paragraph [0026] describes a catheter being able to deform its shape because it is made of a shape memory alloy.
The reason to combine Chook with Swoyer is for the same reasons as in claim 1.
Regarding Claim 15:
Swoyer discloses:
The robotic interventional device control system of Claim 1, wherein the controller is further configured to control rotational movement of the interventional device about a longitudinal axis of the interventional device. Paragraph [0081] describes a robotic catheter cradle 135 coupled to a table cart. The controller adjusts motion of the catheter, such as axially, deflection and/or rotational motion.
Regarding Claim 17:
Swover discloses:
The robotic interventional device control system of Claim 1, wherein the controller is configured to control axial movement of the interventional device along the drive table responsive to a user input. Paragraph [0081] describes a robotic catheter cradle 135 coupled to a table cart. The controller adjusts motion of the catheter, such as axially.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Swoyer in view of Schorr and Chook and further in view of Gregory et al. (US Pub No: 2024/0000524 A1, hereinafter Gregory).
Regarding Claim 5:
Swoyer, Schoor and Chook teach the above limitations in claim 4. Swoyer, Schoor and Chook do not teach a first position being closer to the central longitudinal axis than the second position.
Gregory, in an analogous field of endeavor, teaches:
The robotic interventional device control system of Claim 4, wherein the first position is closer to the central longitudinal axis than the second position. Paragraph [0054] describes a longitudinal axis 218 is below or lower than a central axis to bring the longitudinal device axis 218 closer to the patient.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Swoyer to incorporate the teachings of Gregory to show a first position being closer to the central longitudinal axis than the second position. One would have been motivated to do so because it is desirable to have the longitudinal devices axis to be as close to the patient as possible ([0054] of Gregory).
Claim(s) 10 – 11, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Swoyer in view of Schorr and Chook and further in view of Park et al. (US Pub No: 2015/0265807 A1, hereinafter Park).
Regarding Claim 10:
Swoyer, Schoor and Chook teach the above limitations in claim 1. Swoyer, Schoor and Chook do not teach a position of the interventional device is linked to a first control or a second control of the controller.
Park, in an analogous field of endeavor, teaches:
The robotic interventional device control system of Claim 1, wherein the instrument window further comprises an interventional device marker positioned relative to the representation of the interventional device, and wherein the position of the interventional device marker relative to the representation of the interventional device indicates whether the interventional device is linked to a first control or a second control of the controller. Paragraph [0088] describes a first control 842 configured to roll/rotate and a second control 846 configured to articulate the elongate member 608.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Swoyer to incorporate the teachings of Park to show a position of the interventional device is linked to a first control or a second control of the controller. One would have been motivated to do so to reduce operator error and minimize inadvertent touching of vessel walls ([0088] of Park).
Regarding Claim 11:
Park teaches:
The robotic interventional device control system of Claim 10, wherein the controller comprises a first side and a second side, the first control positioned on the first side of the controller and the second control positioned on the second side of the controller. Paragraph [0095] and figures 15A and 15B describes a controller with buttons on the left, middle and right side.
The reason to combine Park with Swoyer is for the same reason as in claim 10.
Regarding Claim 13:
Park teaches:
The robotic interventional device control system of Claim 1, wherein the instrument window further comprises a pointer extending between the representation of the interventional device and the interventional device marker. Paragraph [0088] describes a bead/arrow position on a virtual indicator.
The reason to combine Park with Swoyer is for the same reason as in claim 10.
Regarding Claim 16:
Park teaches:
The robotic interventional device control system of Claim 15, wherein the interventional device marker further comprises a radial progress indicator configured to provide a visual indication of a degree of rotation relative to a threshold of the interventional device about the longitudinal axis. Paragraph [0059] describes a catheter being obstructed if the difference between the magnitude of the commanded articulation and measured articulation is increased beyond a threshold level. Paragraph [0058] describes a catheter that can rotate.
The reason to combine Park with Swoyer is for the same reason as in claim 10.
Claim(s) 14 are rejected under 35 U.S.C. 103 as being unpatentable over Swoyer in view of Schorr, Chook and Park and further in view of Wallace et al. (US Pub No: 2021/0106346 A1, hereinafter Wallace).
Regarding Claim 14:
Swoyer, Schoor, Chook and Park teach the above limitations in claim 13. Swoyer, Schoor, Chook and Park do not teach a first and second configuration of the interventional device in which the lengths are different.
Wallace, in an analogous field of endeavor, teaches:
The robotic interventional device control system of Claim 13, wherein the pointer comprises a line, wherein when the interventional device marker is in the first configuration, the line comprises a first length, and wherein when the interventional device marker is in the second configuration, the line comprises a second length different than the first length. Paragraph [0153] describes a first and second configuration of a catheter in which in the first configuration, the OD is greater than the second configuration.
Therefore, it would have been prima facie obvious to one of the ordinary skill in the art before the effective filing date, with a reasonable expectation for success, to have modified Swoyer to incorporate the teachings of Wallace to show a first and second configuration of the interventional device in which the lengths are different. One would have been motivated to do so because it depends if the catheter is constrained or unconstrained ([0153] of Wallace).
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Alexander (US Pub No: 2021/0031007 A1): Devices, systems, and methods can articulate catheters and other tools using fluid drive systems that provide robotically coordinated motion. The drive power will often be transmitted from a fluidic driver to the catheter through a series of pneumatic or hydraulic channels and the driver can be isolated from a sterile field by encasing the driver in a sterile housing and directing drive fluid through a sterile junction between the catheter and driver. Interventional physicians can retain tactile feedback by manually advancing the catheter over a wire or the like, and can subsequently bring an interface of the catheter down into engagement with a corresponding driver interface once a therapeutic tool approaches a target site. A sensor may provide signals during manual advancement of the driver and catheter along the catheter axis.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY KHANDPUR whose telephone number is (571)272-5090. The examiner can normally be reached Monday - Friday 8:30 - 6:30.
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, Thomas Worden can be reached at (571) 272-4876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAY KHANDPUR/Primary Patent Examiner, Art Unit 3658