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 .
This office action is in response to applicant’s communication of 6/18/2024. Currently claims 1-20 are pending and rejected or objected below.
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)(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)(2) as being anticipated by SHETH et al. (US 2021/0177506 A1).
Sheth discloses a deflection catheter (100) with an irrigation tube (120) comprising: a flexible tube (120) extending along a longitudinal axis from a proximal end to a distal end; a pull wire (30/32) attached to the flexible tube, the pull wire configured to deflect at least the distal end of the flexible tube radially outward from the longitudinal axis (para [0062]); and an aperture (158) proximate the distal end of the flexible tube, the aperture configured to direct an irrigation fluid outwardly from the irrigation tube so that irrigation fluid is generally directed in a direction of deflection by the pull wire (para [0049]).
Concerning claim 2 and a resilient element configured to return the irrigation tube to a position aligned with the longitudinal axis (examiner is of the position that pull wire 536/538 would provide tension to return the tube to a neutral state).
Concerning claim 3 and an elongated rod (see 524) attached to the irrigation tube.
Concerning claim 4 and the resilient element comprising a spring attached to the irrigation tube (examiner is of the position that pull wire 536/538 would provide tension to return the tube to a neutral state and have resiliency and be considered a spring in the broadest reasonable reading of the claim term).
Concerning claim 5 and the irrigation tube is made from a resilient material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis (examiner is of the position that the tube contains material that makes up the pull wire 536/538 would provide tension to return the tube to a neutral state and be a resilient element function to the tube when in a neutral configuration).
Concerning claim 6 and the aperture (158) being configured to direct the irrigation fluid toward an electrode (examiner is of the position that the electrode is not positively claimed and that the device of Sheth has the function of directing irrigation fluid in a desired location which could be towards an electrode).
Concerning claim 7 and the aperture (158) configured to cause the irrigation tube to oscillate between a first position and a second position when the irrigation fluid passes therethrough (examiner is of the position that the device of Sheth has the function of directing irrigation fluid in a desired location which could be at such force to cause the tube to oscillate, examiner is unclear what special structure the aperture would have from the prior art that would cause a unique oscillation).
Concerning claim 8 and the aperture configured to cause the irrigation tube to rotationally oscillate around the longitudinal axis when the irrigation fluid passes therethrough (examiner is of the position that the device of Sheth has the function of directing irrigation fluid in a desired location which could be at such force to cause the tube to oscillate rotationally around the longitudinal axis, examiner is unclear what special structure the aperture would have from the prior art that would cause a unique oscillation).
Claim Rejections - 35 USC § 103
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) 9-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over BAI et al. (US 2022/0249159 A1) in view of SHETH et al. (US 2021/0177506 A1)
Concerning claim 9 see BAI and a medical probe (see figure 17), comprising: a tubular shaft (210) extending along a longitudinal axis; a plurality of spines (212) configured to bow radially outward from the longitudinal axis; a plurality of electrodes (electrodes on splines 212), each electrode of the plurality of electrodes attached to a spine of the plurality of spines; and an irrigation tube (see para [0069], tube 221. and teachings of Sheth) disposed between the plurality of spines and extending distally from a distal end of the tubular shaft. Examiner is of the position that Sheth teaches the irrigation tube configured to deflect radially outward from the longitudinal axis for the irrigation tube to direct an irrigation fluid to an inwardly-facing surface of an electrode of the plurality of electrodes (see disclosure of Sheth as discussed in claim 1 above).
Bia discloses the claimed invention except for the deflecting irrigation tube. Sheth teaches that it is known to use a deflecting irrigation tube as set forth in para [0002]-[0008] to provide irrigation to cool ablating components of an ablation catheter. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Bia with a deflecting irrigation tube as taught by Sheth, since such a modification would provide the system with a deflecting irrigation tube for providing irrigation to cool ablating components of an ablation catheter.
Concerning claim 10 and the irrigation tube being steerable such that a distal end of the irrigation tube can be moved to direct the irrigation fluid toward the electrode of the plurality of electrodes (note steerable and deflectable function of Sheth irrigation tube.
Concerning claim 11 and a pull wire attached to the irrigation tube, the pull wire configured to steer the irrigation tube (see pull wires 30/32 or Sheth).
Concerning claim 12 of comprising a handle attached to a proximal end of the tubular shaft, the handle further comprising a deflection drive actuator connected to a proximal end of the pull wire, the deflection drive actuator configured to actuate the pull wire to steer the irrigation tube (see figure 7 and actuator 232).
Concerning claim 13 and a resilient element configured to cause the irrigation tube to return to a position aligned with the longitudinal axis (examiner is of the position that the tube contains material that makes up the pull wire 536/538 would provide tension to return the tube to a neutral state and be a resilient element function to the tube when in a neutral configuration).
Concerning claim 14 and the irrigation tube is further configured to slide longitudinally along the longitudinal axis from a proximal end of the plurality of spines to a distal end of the plurality of spines (note element of Bai 221 that can slide the entirety of the device).
Concerning claim 15 and in a most distal position of the irrigation tube, a gap is formed between the irrigation tube and the plurality of spines such that the irrigation tube does not contact the plurality of spines (it is examiners position that if the tube of Sheth extended from Bai there would be a gap between the tube and spines so the tube does not contact the spines).
Concerning claim 16 and the irrigation tube is made from a resilient material such that the irrigation tube is configured to return to a position aligned with the longitudinal axis (examiner is of the position that the tube contains material that makes up the pull wire 536/538 would provide tension to return the tube to a neutral state and be a resilient element function to the tube when in a neutral configuration, along a longitudinal axis).
Concerning claim 17 and the irrigation tube comprising an aperture configured to direct the irrigation fluid toward the electrode of the plurality of electrodes (examiner is of the position that the device of Sheth has the function of directing irrigation fluid in a desired location which could be towards an electrode).
Concerning claim 18 and the aperture configured to cause the irrigation tube to oscillate between a first position and a second position when the irrigation fluid passes therethrough (examiner is of the position that the device of Sheth has the function of directing irrigation fluid in a desired location which could be at such force to cause the tube to oscillate rotationally around the longitudinal axis, examiner is unclear what special structure the aperture would have from the prior art that would cause a unique first and second position oscillation).
Concerning claim 19 and the aperture configured to cause the irrigation tube to rotationally oscillate around the longitudinal axis when the irrigation fluid passes therethrough (examiner is of the position that the device of Sheth has the function of directing irrigation fluid in a desired location which could be at such force to cause the tube to oscillate rotationally around the longitudinal axis, examiner is unclear what special structure the aperture would have from the prior art that would cause a rotational oscillation).
Concerning claim 20 and the irrigation tube being configured deflect radially outward such that a distal end of the irrigation tube maintains at least a distance of approximately 0.25 mm from an electrode (examiner is of the position that the device of Sheth has the function of directing irrigation fluid in a desired location which could be towards an electrode and spaced at least 0.25 mm away from an electrode of Bai).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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