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 .
Response to Arguments
Applicant’s arguments, see pg. 15-16, filed 06/10/2026, with respect to the drawings objection have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see pg. 16, filed 06/10/2026, with respect to the 35 USC 112(b) rejection of “tortuous” have been fully considered and are persuasive. The 112(b) rejection of claims 1-20, specifically with respect to “tortuous” being a relative term, has been withdrawn.
Applicant’s arguments, see pg. 16-17, filed 06/10/2026, with respect to the 35 USC 112(b) rejection of “medical system” and the lack of positive recitation have been fully considered and are persuasive. While the amended claims still do not positively recite the medical system, the scope of the claim is clear and definite. The 112(b) rejection of claims 1-18, specifically with respect to the positive recitation of “medical system”, has been withdrawn.
Applicant’s arguments, see pg. 17, filed 06/10/2026, with respect to the claim 2 objection have been fully considered and are persuasive. The objection of claim 2 has been withdrawn.
Applicant's arguments, see pg. 18-19, regarding the 35 USC 102(a)(1) rejection of claims 1-3, 9-15, and 19-20 have been fully considered but they are not persuasive.
Applicant argues that Cheung does not disclose “spaced-apart electrodes positioned along a length of the microcatheter”. As seen below, Fig. 1 of Cheung discloses ring electrodes 22 positioned along “a length” of the shaft 12. Although Cheung states that the ring electrodes are disposed on a distal portion of the shaft 12 (see [0083]), the “length” of the instant application can be considered to be equivalent to “a distal portion” of Cheung. Further, the “distal portion of the microcatheter” of the instant application can be equivalent to the distal ablation tip electrode 24 of Cheung. “Length” and “distal portion” are subjective/relative terms that can be interpreted broadly.
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Applicant additionally argues that the examiner relies on Cheung to satisfy “a distal most positioned electrode of the spaced-apart electrodes [is] spaced apart from the distal energy emitter. The examiner instead relied on Panescu to meet this limitation (see pg. 12 of non-final rejection filed 02/12/2026).
Applicant's arguments, see pg. 19-20, regarding the 35 USC 103 rejection of claims 1-3, 9-15, and 19-20 have been fully considered but they are not persuasive.
Applicant argues that Panescu does not teach “a distal most positioned one electrode of the spaced-apart electrodes is spaced apart from the distal energy emitter”.
Panescu discloses in [0239], Fig. 2 (see below):
FIG. 2 illustrates one embodiment of a distal end of a medical instrument (e.g., catheter) 20. As shown, the catheter 20 can include a high-resolution tip design, such that there are two adjacent electrodes or two adjacent electrode portions 30A, 30B separated by a gap G.
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As previously stated, the examiner relies on Cheung in the non-final rejection to teach the spaced-apart electrodes and distal energy emitter. Since Cheung does not specifically disclose a gap between the electrodes, Panescu is relied on. Therefore, the combination of Cheung and Panescu teach the limitation.
The examiner agrees that the amendments to claims 1, 19 and 20 to include added limitations overcomes the 35 USC 102(a)(1) and 103 rejections detailed in the non-final rejection. Since independent claims 1, 19 and 20 were amended to include new limitations, new grounds for rejection are warranted for independent claims 1, 19, and 20 and dependent claims 2-14, 16-18, and 21. See prior art rejections below.
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.
Claims 1-7, 9-14, and 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cheung et al. (US Pre-Grant Publication 2016/0113712), hereinafter ‘Cheung’, in view of Panescu et al. (US Pre-Grant Publication 2016/0278856), hereinafter ‘Panescu’.
Regarding claim 1, Cheung teaches an apparatus (system (10)) usable with a medical system (processor (16)) (Fig. 1) and biological tissue of a patient ([0085], ablation procedures on patient), the apparatus comprising:
a microcatheter (elongated member or catheter shaft (12)) including spaced-apart electrodes positioned along a length of the microcatheter (Fig. 1) (ring electrodes (22)), a distal energy emitter (distal ablation tip electrode (24)) mounted to a distal portion of the microcatheter (distal portion (13)),
wherein the microcatheter is configured to:
have a geometry being movable along a tortuous anatomy of the patient ([0084], navigate vasculature of patient or other lumens);
be positionable, at least in part, proximate to the biological tissue ([0086], proximate to myocardial tissue);
emit an information signal, related to the biological tissue ([0086], generate output signal corresponding to myocardial tissue), in a manner that is receivable and processable by the medical system when in use; and
be selectively signal connectable to the medical system ([0087], electrode outputs coupled to and sent to processor) and selectively connectable to an energy source (RF generator (14)) (Fig. 1) to be operable under at least a first operational mode and a second operational mode ([0086], unipolar and bipolar sensing modes).
Cheung does not explicitly teach a distal most electrode of the spaced-apart electrodes being spaced apart from the distal energy emitter. Cheung teaches that the microcatheter may be used to map and/or ablate myocardial tissue (see [0085]), but does not explicitly teach mutually exclusive signal communication/energy emission modes.
Panescu teaches an ablation device [0004] (catheter (20)), the device further comprising:
a distal most positioned one electrode of the spaced-apart electrodes (proximal electrode portion (30B)) is spaced apart from the distal energy emitter (distal electrode portion (30A)) (Fig. 2, gap G, separator (34)); and
operable under at least a fist operational mode ([0409], contact sensing/contact determination assessment) and a second operational mode ([0409], ablative energy delivery) that are mutually exclusive such that:
in the first operational mode, the microcatheter is configured to facilitate signal communication and to disable emission of energy from the distal energy emitter; and
in the second operational mode, the microcatheter is configured to facilitate emission of energy from the distal energy emitter and to disable signal communication ([0409], switching utilized to separate contact impedance measurement circuitry from ablative energy, Fig. 26C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheung to incorporate the teachings of Panescu to include a separation between the distal most electrode along the length of the catheter and the distal energy emitter, and mutually exclusive signal communication/energy emission modes. Doing so would provide electrical insulation of the electrode portions and to avoid a short circuit, as recognized by Panescu ([0243] and [0409]).
Regarding claim 2, Cheung and Panescu teach the device of claim 1. Cheung teaches the device further comprising:
the microcatheter is further configured to:
detect presence of the biological tissue that is positioned or located, at least in part, proximate to the microcatheter ([0086], proximate myocardial tissue);
and transmit the information signal, indicating detection of the presence of the biological tissue ([0087], contact assessment), to the medical system in a manner that facilitates generation of a medical image ([0089], display includes image of target area), based on computations performed on the information signal that was provided by the microcatheter ([0089], processor generates output to display).
Regarding claim 3, Cheung and Panescu teach the device of claim 1. Cheung teaches the device further comprising:
the microcatheter is further configured to:
be selectively connectable to an energy source (RF generator (14)) (Fig. 1);
and selectively emit, at least in part, energy toward the biological tissue for treating the biological tissue ([0085], apply ablation energy to myocardial tissue).
Regarding claim 4, Cheung and Panescu teach the device of claim 3. Panescu teaches the device further comprising:
wherein, in the first operational mode:
the microcatheter is configured to not emit energy while the microcatheter, in use, detects the biological tissue that is positioned proximate to the microcatheter ([0409], contact sensing not performed during energy delivery).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Cheung to incorporate the teachings of Panescu to include mutually exclusive mapping and ablation modes. Doing so would avoid interference at EGM frequencies, as recognized by Panescu [0216].
Regarding claim 5, Cheung and Panescu teach the device of claim 3. Panescu teaches the device further comprising:
wherein, in the first operational mode:
the microcatheter is configured to not emit energy while the microcatheter, in use, transmits the information signal that is associated with the biological tissue ([0409], contact determination assessments not performed during energy delivery).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Cheung to incorporate the teachings of Panescu to include mutually exclusive mapping and ablation modes. Doing so would avoid interference at EGM frequencies, as recognized by Panescu [0216].
Regarding claim 6, Cheung and Panescu teach the device of claim 3. Panescu teaches the device further comprising:
in the first operational mode, the microcatheter is configured to not emit energy while the microcatheter, in use, assists a surgeon in positioning the microcatheter at a desired position on a medical image generated based on the information signal ([0406-0407], contact sensing/determination includes indication of tissue contact, [0431], output to user interface, Fig. 33).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Cheung to incorporate the teachings of Panescu to include mutually exclusive mapping and ablation modes. Doing so would avoid interference at EGM frequencies, as recognized by Panescu [0216].
Regarding claim 7, Cheung and Panescu teach the device of claim 3. Panescu teaches the device further comprising:
in the second operational mode:
the microcatheter is configured to not detect biological tissue while the microcatheter, in use, selectively emits energy toward the biological tissue as indicated in a medical image that was generated from the information signal provided by the microcatheter ([0409], when ablations are to be performed, impedance measurement circuit is disconnected).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Cheung to incorporate the teachings of Panescu to include mutually exclusive mapping and ablation modes. Doing so would avoid interference at EGM frequencies, as recognized by Panescu [0216].
Regarding claim 9, Cheung and Panescu teach the device of claim 3. Cheung teaches the device further comprising:
the microcatheter has a proximal microcatheter portion and a distal microcatheter portion ([0083], proximal/distal portions of shaft (12)).
Regarding claim 10, Cheung and Panescu teach the device of claim 9. Cheung teaches the device further comprising:
the distal microcatheter portion has a distal tip section (distal portion (13)) supporting the distal energy emitter (distal ablation tip electrode (24)) configured to selectively emit energy toward the biological tissue ([0085], apply ablation energy).
Regarding claim 11, Cheung and Panescu teach the device of claim 3. Cheung teaches the device further comprising:
the microcatheter is configured to be selectively connectable to the medical system (Fig. 1, processor (16)).
Regarding claim 12, Cheung and Panescu teach the device of claim 11. Cheung teaches the device further comprising:
the microcatheter is configured to be selectively connectable to an energy source (RF generator 14, Fig. 1) to receive energy from the energy source ([0082], deliver ablation energy to shaft).
Regarding claim 13, Cheung and Panescu teach the device of claim 11. Cheung teaches the device further comprising:
the microcatheter is configured to provide an ECG signal to the medical system ([0086-0087], EGM reading).
Regarding claim 14, Cheung and Panescu teach the device of claim 11. Cheung teaches the device further comprising:
the microcatheter is configured to include at least one sensor configured to detect an electrocardiogram signal [0086, microelectrode pair can generate EGM sensed signal].
Regarding claim 16, Cheung and Panescu teach the device of claim 1. Cheung teaches the device further comprising:
the spaced-apart electrodes are fixedly positioned along the length of the microcatheter (Fig. 1) (ring electrodes (22)).
Regarding claim 17, Cheung and Panescu teach the device according to claim 16. Cheung teaches the device further comprising:
any one electrode of the spaced-apart electrodes is configured to emit the information signal, related to the biological tissue, to the medical system ([0089], processors receive signals from electrodes);
and the distal energy emitter is configured to selectively emit, at least in part, energy toward the biological tissue for treating the biological tissue ([0085], apply ablation energy to myocardial tissue).
Regarding claim 18, Cheung and Panescu teach the device of claim 1. Cheung teaches the device further comprising:
the spaced-apart electrodes are fixedly positioned along the length of the microcatheter (Fig. 1) (ring electrodes (22)); and the microcatheter includes:
and any one electrode of the spaced-apart electrodes is configured to emit the information signal, related to the biological tissue, to the medical system ([0089], processors receive signals from electrodes); and
the distal energy emitter is configured to selectively emit, at least in part, energy toward the biological tissue for treating the biological tissue ([0085], apply ablation energy to myocardial tissue); and
a selected electrode of the spaced-apart electrodes is configured to selectively emit, at least in part, energy toward the biological tissue for treating the biological tissue ([0085], ring electrodes can map and/or ablate tissue).
Regarding claim 19, Cheung teaches an apparatus (system (10)) (Fig. 1) comprising:
a medical system (processor (16)); and
a microcatheter (elongated member or catheter shaft (12)) including spaced-apart electrodes positioned along a length of the microcatheter (Fig. 1) (ring electrodes (22)) and a distal energy emitter (distal ablation tip electrode (24)) mounted to a distal portion of the microcatheter (distal portion (13)),
wherein the microcatheter is configured to:
be positionable, at least in part, proximate to biological tissue of a patient ([0086], proximate to myocardial tissue) responsive to movement of the microcatheter along a tortuous anatomy of the patient ([0084], navigate vasculature of patient or other lumens);
emit an information signal, related to the biological tissue ([0086], generate output signal corresponding to myocardial tissue), to the medical system so that the medical system, in use, receives the information signal from the microcatheter and processes, in use, the information signal received from the microcatheter ([0087], process electric signals) (processor (16)); and
be selectively signal connectable to the medical system ([0087], electrode outputs coupled to and sent to processor) and selectively connectable to an energy source (RF generator (14)) (Fig. 1), the microcatheter being operable under at least a first operational mode and a second operational mode ([0086], unipolar and bipolar sensing modes).
Cheung does not explicitly teach a distal most electrode of the spaced-apart electrodes being spaced apart from the distal energy emitter. Cheung teaches that the microcatheter may be used to map and/or ablate myocardial tissue (see [0085]), but does not explicitly teach mutually exclusive signal communication/energy emission modes.
Panescu teaches an ablation device [0004] (catheter (20)), the device further comprising:
a distal most positioned one electrode of the spaced-apart electrodes (proximal electrode portion (30B)) is spaced apart from the distal energy emitter (distal electrode portion (30A)) (Fig. 2, gap G, separator (34)); and
operable under at least a fist operational mode ([0409], contact sensing/contact determination assessment) and a second operational mode ([0409], ablative energy delivery) that are mutually exclusive such that:
in the first operational mode, signal communication with the medical system is enabled and emission of energy is disabled, and
in the second operational mode, emission of energy is enabled and signal communication with the medical system is disabled ([0409], switching utilized to separate contact impedance measurement circuitry from ablative energy, Fig. 26C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheung to incorporate the teachings of Panescu to include a separation between the distal most electrode along the length of the catheter and the distal energy emitter, and mutually exclusive signal communication/energy emission modes. Doing so would provide electrical insulation of the electrode portions and to avoid a short circuit, as recognized by Panescu ([0243] and [0409]).
Regarding claim 20, Cheung and Panescu teach a method usable with a medical system and biological tissue of a patient (Cheung, [0085], myocardial tissue). See above rejection of similarly worded claim 19.
Regarding claim 21, Cheung and Panescu teach the device according to claim 1. Panescu teaches the device further comprising:
during a transition from the first operational mode to the second operational mode, the microcatheter is configured to disable signal communication with the medical system before enabling emission of energy from the distal energy emitter, and
wherein, during a transition from the second operational mode to the first operational mode, the microcatheter is configured to disable connection to the energy source before enabling signal communication with the medical system ([0409], switching may be utilized to separate the contact impedance measurement circuitry from the ablative energy, Fig. 2C, switch SW1 disconnected and SW2 and SW3 are connected).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified Cheung to incorporate the teachings of Panescu to include disconnecting the energy source before connecting the signal communication mechanism. Doing so would prevent a short circuit, as recognized by Panescu [0409].
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Cheung et al. (US Pre-Grant Publication 2016/0113712) in view of Panescu et al. (US Pre-Grant Publication 2016/0278856), further in view of Davies et al. (US Pre-Grant Publication 2020/0353215), hereinafter ‘Davies’.
Regarding claim 8, Cheung and Panescu teach the device according to claim 3, but do not teach a sheath or dilator.
Davies teaches a method and device for puncturing tissue and inserting a catheter ([0009], [0013]), the device comprising:
the microcatheter (catheter assembly (200)) is configured to:
be usable with a sheath (sheath (230));
and be usable with a dilator (dilator (220)) configured to be received, at least in part, into the sheath [0033];
and be received, at least in part, into the dilator [0073] (Figs. 2A, 2B);
and wherein the sheath and the dilator are configured to be advanced over the microcatheter to a desired location [0078].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Cheung and Panescu to incorporate the teachings of Davies to include a system that includes a dilator and sheath usable together. Doing so would provide stiffness to facilitate force/torque transmission to the distal end of the catheter, as recognized by Davies [0077].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stewart et al. (US Pre-Grant Publication 2018/0325586) discloses an ablation catheter with mapping capabilities.
Koblish et al. (US Pre-Grant Publication 2013/0190747) discloses an ablation catheter and mapping processor with a visual display.
Ubranski et al. (US Pre-Grant Publication 2021/0068892) discloses a puncture device with electrodes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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