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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 501-519. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-20, the term “tortuous” in claims 1, 19, 20 is a relative term which renders the claims indefinite. The term “tortuous” 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. The definition of “tortuous” (Dictionary.com: full of twists, turns, or bends; twisting, winding, or crooked) covers a wide range of geometry such that it is not clear what degree of deviation from entirely straight is required to meet the limitation.
Regarding claims 1-18, the “medical system” in claim 1 is not positively recited and is therefore not required by the claim, which renders the scope of the claims indefinite.
Regarding claim 1, further limiting the functionality of the medical system (“the medical system, in use, receives the information signal from the microcatheter and processes, in use, the information signal received from the microcatheter”) renders the claim indefinite because the medical system is not required by the claim, which makes it unclear how this additional functionality would change the scope of the claim.
Regarding claim 2, the “medical-imaging system” is said to be included with the medical system, so the medical-imaging system is therefore also not required by the claim. However, its functionality is further limited in claim 2 (“the medical-imaging system configured to generate a medical image”). Since the claim, under the broadest reasonable interpretation, does not include a “medical-imaging system”, it is unclear how adding functionality would change the claim scope.
The additional claims include further indefinite limitations, specifically:
Medical-imaging system (claim 6)
Medical image produced by medical-imaging system (claim 6)
Energy source of the medical system (claim 11)
ECG system of the medical system (claim 13)
It is unclear how these additional limitations would change the scope of the claims.
For the purpose of continued examination, the examiner has interpreted claim 1 as requiring the medical system.
Claim Objections
Claim 2 is objected to because of the following informalities: a closed parenthesis (“)”) with no corresponding open parenthesis is present at the end of the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-3, 9-15, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cheung et al. (US Pre-Grant Publication 2016/0113712), hereinafter ‘Cheung’.
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)) configured to:
have a geometry being movable along a tortuous anatomy of the patient ([0084], navigate vasculature of patient or other lumens);
and be positionable, at least in part, proximate to the biological tissue ([0086], proximate to myocardial tissue);
and 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)).
Regarding claim 2, Cheung teaches the apparatus according to claim 1, further comprising:
the medical system includes a medical-imaging system ([0089], display includes image of target area);
and 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-imaging system configured to generate a medical image, based on computations performed on the information signal that was provided by the microcatheter ([0089], processor generates output to display).
Regarding claim 3, Cheung teaches the device according to claim 1, 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 9, Cheung teaches the device according to claim 3, 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 teaches the device according to claim 9, further comprising:
the distal microcatheter portion has a distal tip section (distal portion (13)) supporting a 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 teaches the device according to claim 3, further comprising:
the microcatheter is configured to be selectively connected to the medical system (Fig. 1, processor (16)).
Regarding claim 12, Cheung teaches the device according to claim 11, further comprising:
the medical system includes an energy source (RF generator (14)) being configured to:
be operatively connected to the microcatheter (Fig. 1);
and provide energy to the microcatheter after the energy source is operatively connected to the microcatheter ([0082], deliver ablation energy to shaft).
Regarding claim 13, Cheung teaches the device according to claim 11, further comprising:
the medical system includes an ECG system configured to collect an ECG signal to be provided by the microcatheter ([0086-0087], EGM reading).
Regarding claim 14, Cheung teaches the device according to claim 11, 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 15, Cheung teaches the device according to claim 1, further comprising:
the microcatheter includes spaced-apart electrodes fixedly positioned along a length of the microcatheter (Fig. 1) (ring electrodes (22)).
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)) 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);
and 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)).
Regarding claim 20, Cheung teaches a method usable with a medical system and biological tissue of a patient, the method comprising:
using a microcatheter (elongated member or catheter shaft (12)) configured to:
have a geometry being movable along a tortuous anatomy of the patient ([0084], navigate vasculature of patient or other lumens);
and be positionable, at least in part, proximate to the biological tissue ([0086], proximate to myocardial tissue);
and emit an information signal, related to the biological tissue ([0086], generate output signal corresponding to myocardial tissue), to the medical system (processor (16)) 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)).
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 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cheung et al. (US Pre-Grant Publication 2016/0113712) in view of Ngo et al. (US Pre-Grant Publication 2017/0319260), hereinafter ‘Ngo’.
Regarding claim 4, Cheung teaches the device according to claim 3, but does not teach the limitations of claim 4.
Ngo teaches a medical system (100) for cardiac ablation and mapping [0002], further comprising:
the microcatheter (cardiac ablation catheter (103)) is configured to not emit energy while the microcatheter, in use, detects the biological tissue that is positioned proximate to the microcatheter ([0038], disable energy outputting in a second mode) ([0013], second mode is tissue monitoring).
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 Ngo to include a system that prevents the microcatheter from emitting energy if the biological tissue is being detected. Doing so would prevent interference of the different medical procedures, as recognized by Ngo [0010].
Regarding claim 5, Cheung teaches the device according to claim 3. Ngo teaches the device further comprising:
the microcatheter is configured to not emit energy while the microcatheter, in use, transmits the information signal that is associated with the biological tissue ([0031], transmit cardiac mapping/navigation signals) ([0033], monitor signals during intervals between ablation).
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 Ngo to include a system that prevents the microcatheter from emitting energy if information about the biological tissue is being transmitted. Doing so would prevent interference of the different medical procedures, as recognized by Ngo [0010].
Regarding claim 6, Cheung teaches the device according to claim 3, but does not teach the limitations of claim 6.
Ngo teaches a medical system (100) for cardiac ablation and mapping [0002], further comprising:
the medical system includes a medical-imaging system (cardiac mapping/signal monitor (210)); and
the microcatheter is configured to not emit energy while the microcatheter, in use, assists the surgeon in positioning the microcatheter at a desired position on a medical image formed by the medical-imaging system ([0020], display attributes of different locations during non-ablation windows) ([0081], positioning of catheter).
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 Ngo to include a medical imaging system and a system that prevents the microcatheter from emitting energy if the surgeon is being assisted in positioning the device. Doing so would prevent interference of the different medical procedures, as recognized by Ngo [0010].
Regarding claim 7, Cheung teaches the device according to claim 3. Ngo teaches the device further comprising:
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 ([0105], mapping occurs during non-ablation windows).
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 Ngo to include a system that prevents the microcatheter from detecting signals for cardiac mapping while ablation is occurring. Doing so would prevent interference of the different medical procedures, as recognized by Ngo [0010].
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 Davies et al. (US Pre-Grant Publication 2020/0353215), hereinafter ‘Davies’.
Regarding claim 8, Cheung teaches the device according to claim 3, but does not teach the limitations of claim 8.
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 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].
Claims 16-18 are 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), hereinafter ‘Panescu’.
Regarding claim 16, Cheung teaches the device according to claim 1, further comprising:
spaced-apart electrodes fixedly 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)).
Cheung does not teach a distal most electrode of the spaced-apart electrodes being spaced apart from the distal energy emitter.
Panescu teaches an ablation device [0004] (catheter (20)), the device further comprising:
and 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)).
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. Doing so would provide electrical insulation of the electrode portions, as recognized by Panescu [0243].
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 teaches the device according to claim 1, further comprising:
the microcatheter includes: spaced-apart electrodes fixedly 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));
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).
Cheung does not teach a distal most electrode of the spaced-apart electrodes being spaced apart from the distal energy emitter.
Panescu teaches an ablation device [0004] (catheter (20)), the device further comprising:
and 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)).
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. Doing so would provide electrical insulation of the electrode portions, as recognized by Panescu [0243].
Conclusion
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.
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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