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 .
Election/Restrictions
Applicant's election with traverse of Species A in the reply filed on 8/4/2026 is acknowledged. The traversal is on the ground(s) that the examiner has not provided an explanation of the serious search burden. This is not found persuasive because a search for the different types of sensors required by the different species will require different search queries including at least different text search fields.
The requirement is still deemed proper and is therefore made FINAL.
Additionally, the examiner notes that Applicant has identified claims 21-23, 25-40 are being drawn to the elected species. This does not appear to be correct as elected Species A includes a proximity sensor as laid out in claim 24. Therefore, claim 24 should not be withdrawn, and claims 25 and 26 are withdrawn as being drawn to a non-elected species.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 15/425,982, 16/861,633, 17/647 325, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. These applications fail to provide support for at least the claim 21 limitation “a control unit in the handle body configured to generate, in response to control signals generated in response to the catheter steering commands signals and the feedback signals, catheter deflection command signals.” Particularly, a control unit receiving feedback signals and generating catheter deflection command signals in response thereto. The feedback signals are described as signals provided to the user, not to a control unit.
Therefore, the effective filing date of the claimed invention is the filing date of the claims – 8/30/2024.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-24, 27-40 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 21 recites “a control unit in the handle body configured to generate, in response to control signals generated in response to the catheter steering commands signals and the feedback signals, catheter deflection command signals.” The disclosure does not provide support for a control unit receiving feedback signals and generating catheter deflection command signals in response thereto. The feedback signals are described as signals provided to the user, not to a control unit. Therefore, it is not clear that Applicant had possession of the claimed invention at the time the application was filed.
Claims 22-40 include the limitations of claim 21 and therefore are similarly rejected.
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.
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) 21-24, 27-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Douglas et al (US 2022/0126065) in view of Shia (US 2022/0039635).
Regarding claim 21, Douglas discloses an augmented control hand-held catheter apparatus, comprising: a handle body 325 extending from a proximal end to a distal end along a longitudinal axis (fig. 3); a catheter structure 345 coupled to the handle body and extending distally therefrom to a steerable tip deflectable in a plurality of axes by control wires (fig. 3; page 2, para. 0025, 0027); a user input interface 310 on an outer surface of the handle body and configured to generate catheter steering command signals in response to user input at the user input interface (page 2, para. 0027; fig. 3); at least one feedback unit disposed in the catheter structure and configured such that feedback signals are generated related to a position of the steerable tip (page 3, para. 0031-0038); a control unit 315 in the handle body configured to generate, in response to control signals generated in response to the catheter steering command signals a catheter deflection command signals (page 2, para. 0027); and, at least one deflection actuator 320 disposed in the handle body and configured to operate the control wires, in response to the catheter deflection command signals (page 2, para. 0027), such that the steerable tip of the catheter structure is deflected in at least one of the plurality of axes according to the catheter steering command signals generated in response to the user input (page 2, para. 0027), wherein the handle body is configured to be supported by and manipulated by at least one human hand (fig. 3).
Claim 21 calls for the control unit to generate, in response to control signals generated in response to the catheter steering command signals and the feedback signals, catheter deflection command signals. Douglas fails to disclose that the deflection command signal is generated in response to the feedback signals. Shia teaches a catheter steering control unit that generates a deflection command signal based on user inputs and feedback signals to ensure that the catheter can be safely navigated through tortuous pathways in the patient’s anatomy without applying a damaging amount of force to the body (page 6, para. 0045). 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 control unit of Douglas such that the control unit generates the deflection command signal based on user input and feedback from the sensors as taught by Shia to increase the safety of the device as damaging forces within the body are prevented.
Regarding claim 22, Douglas discloses that the control signals are generated by the control unit in the handle body (page 2, para. 0027).
Regarding claim 23, Douglas discloses that the at least one feedback unit comprises a sensor (page 3, para. 0033).
Regarding claim 24, Douglas discloses that the sensor comprises a proximity sensor (page 3, para. 0037).
Regarding claim 27, Douglas discloses that the at least one feedback unit generates the feedback signals (page 3, para. 0032).
Regarding claim 28, Douglas discloses that the at least one deflection actuator comprises an electromechanical actuator (page 2, para. 0027).
Regarding claim 29, Douglas discloses that the electromechanical actuator comprises an electromagnetic actuator (page 3, para. 0042).
Regarding claim 30, Douglas discloses that the at least one feedback unit comprising a plurality of sensors (page 3, para. 0040).
Regarding claim 31, Douglas discloses that the user input interface further generates a rotation command signal in response to the user input at the user input interface (page 2, para. 0027), and further comprising: a rotational actuator module disposed in the handle body and having a rotatable output, wherein the rotational actuator module controls an angular rotation of the rotatable output in response to the rotation command signal (page 2, para. 0027); and, a catheter interface 335 rigidly coupled to the catheter structure, the catheter interface rotatably coupled to a distal end of the handle body and coupled to rotate the catheter structure about the longitudinal axis in response to rotation of the rotatable output (page 2, para. 0027; fig. 3).
Regarding claim 32, Douglas discloses a gear module 340 coupling the rotatable output to the catheter interface (page 2, para. 0027; fig. 3).
Regarding claim 33, Douglas discloses that the handle body further comprises a hollow region that contains: the control unit, the at least one deflection actuator, or some combination thereof (fig. 3).
Regarding claim 34, Douglas discloses a grip portion formed at the proximal end and configured to be gripped by a user performing a catheter procedure in a body of a patient (fig. 1).
Regarding claim 35, Douglas discloses a feedback interface on the handle body configured to receive the feedback signals from the at least one feedback unit in the catheter structure, wherein the control unit comprises a processor operably coupled to receive the feedback signals and to generate in response thereto a predetermined haptic feedback to a user while the user is holding the handle body (pages 8-9, claim 5).
Regarding claim 36, Douglas discloses that the user input interface is further configured to generate a linear translation output to the catheter structure in response to the user input, and further comprising a linear actuator module configured to displace at least one control member operably coupled to the steerable tip (page 9, claim 16).
Regarding claim 37, Douglas discloses that the handle body is disposable (page 2, para. 0027).
Regarding claim 38, Douglas discloses that the handle body is releasably coupled to the catheter structure (page 2, para. 0027).
Regarding claim 39, Douglas discloses that the handle body is fixedly coupled to the catheter structure (fig. 1).
Regarding claim 40, Douglas discloses that the handle body is configured as a unitary structure (page 5, para. 0057).
Conclusion
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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