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)(4) because reference character “100” has been used to designate both the transseptal puncturing system and the guidewire as seen in Figure 1. 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 § 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.
Claims 1-5, 7, 9-15, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (U.S. Application No. 20160175009 A1), and further in view of Ganapathy (U.S. Application No. 20200129086 A1).
Regarding independent claim 1, Davies discloses a transseptal puncturing system (50) (pa. 0132 & Figs. 1, 7c) comprising:
a steerable microcatheter comprising an elongated member (104) (pa. 0142) with a lumen extending therethrough to define a longitudinal axis (pa. 0046), a deflectable distal portion (100b) (pa. 0049 & Fig. 1A);
a guidewire (200) disposed within the lumen of the microcatheter (pa. 0083 & Fig. 5a) comprising an electrically conductive core (204), an electrically conductive distal end (202, 208) (pa. 0084), an electrically conductive proximal end (206) (pa. 0124), and an outer diameter less than and approximately equal to an inner diameter of the lumen of the microcatheter (see Figs. 3A-3B); and
a generator (500) in electrical contact with the electrically conductive proximal end (pa. 0047), the generator being configured to provide electrical energy to the distal end of the guidewire sufficient to puncture tissue without requiring a sharp end (pa. 0084, 0103).
However, Davies does not disclose a location sensor disposed proximate the deflectable distal portion.
Ganapathy, in the same field of endeavor, teaches a surgical instrument including an impedance sensing system for monitoring the position of the tip of the surgical instrument relative to the pericardial space (pa. 0042), wherein the surgical instrument includes two or more ring electrodes (202) mounted on the external surface of the instrument and a pad electrode (214) applicable to the skin of a patient. The ring electrodes and the pad electrode are connected to an impedance analyzer (226) (pa. 0075 & Figs. 7, 8) which includes at least one signal generating circuit (220) and at least one signal measuring circuit (222) which determines the impedance between the ring electrodes and the pad electrode (pa. 0076-0078) in order to calculate the position of the tip of the surgical instrument relative to the pericardial space.
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 added the impedance sensing system of Ganapathy, including the ring electrodes disposed proximate the deflectable distal portion, the pad electrode, and the impedance analyzer, to the transseptal puncturing system of Davies for the purpose of allowing the user to accurately determine the position of the deflectable distal portion in order to avoid undesirable treatment outcomes such as puncturing/targeting undesirable tissue of the patient.
Regarding claim 2, Davies discloses the invention substantially as claimed in claim 1 discussed above.
However, Davies does not disclose a navigation module configured to determine a position of the distal end of the microcatheter in a heart based at least in part on the location sensor in reference to the electrically conductive distal end of the guidewire.
Ganapathy, in the same field of endeavor, teaches a surgical instrument including an impedance sensing system/navigation module for monitoring the position of the tip of a guidewire relative to the pericardial space (pa. 0012, 0042). The navigation module comprises an impedance analyzer (226) (pa. 0075 & Figs. 7, 8) which includes at least one signal generating circuit (220) and at least one signal measuring circuit (222) which determines the impedance between multiple electrodes. The impedance values may be either directly displayed to an operator in the form of absolute impedance values (variable X) or in the form of relative impedance values (variable Y) which have been normalized by a reference value unique to the patient being operated (pa. 0042). The reference impedance values are collected at different locations on the patient using electrodes of the surgical instrument or other electrodes placed within the patient. The absolute impedance values may be normalized by the reference impedance values and expressed as an impedance ratio (X/Y). Impedance ratios within defined ranges may indicate the position of the tip of the surgical instrument, whether within the pericardial space, the intramural right ventricular space, or the anterior mediastinal space (pa. 0043-0044).
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 added the impedance sensing system of Ganapathy, including the impedance analyzer, to the transseptal puncturing system of Davies for the purpose of allowing the user to accurately determine the position of the deflectable distal portion in order to avoid undesirable treatment outcomes such as puncturing/targeting undesirable tissue of the patient.
Regarding claims 3 and 13, Davies/Ganapathy combination discloses further comprising:
a dilator (100) comprising a lumen therethrough comprising an inner diameter greater than and approximately equal to the inner diameter of the lumen of the microcatheter (Davies, pa. 0061); and
a sheath (300) configured to advance over the dilator (Davies, pa. 0046).
Regarding claims 4 and 14, Davies/Ganapathy combination discloses further comprising:
a sheath (300) configured to advance over the microcatheter (Davies, pa. 0046),
wherein the microcatheter comprises a tapered distal end (100 a) (Davies, pa. 0062), and
wherein the tapered distal end comprises a distal outer diameter greater than and approximately equal to the outer diameter of the guidewire (Davies, see Figs. 3A-3B) and a proximal outer diameter less than and approximately equal to inner diameter of a lumen of the sheath (Davies, see Figs. 3A-3B).
Regarding claims 5 and 17, Davies/Ganapathy combination discloses wherein the steerable microcatheter further comprises a pull wire connected to the distal portion to deflect the distal portion with respect to the longitudinal axis (Davies, pa. 0037, 0155).
Regarding claim 7, Davies discloses the invention substantially as claimed in claim 1 discussed above.
However, Davies does not disclose a mapping module configured to generate a map of at least a portion of an interatrial septum using the location sensor.
Ganapathy, in the same field of endeavor, teaches a mapping module configured to generate a map of at least a portion of the targeted tissue using the location sensor (pa. 0042).
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 added the mapping module taught by Ganapathy to the transseptal puncturing system of Davies for the purpose of allowing the user to better visualize the targeted tissue for treatment purposes.
Regarding claims 9 and 19, Davies discloses the invention substantially as claimed in claims 1 and 11 discussed above.
However, Davies does not disclose wherein the location sensor comprises an exposed electrode.
Ganapathy, in the same field of endeavor, teaches wherein the location sensor comprises an exposed electrode (see electrodes on Fig. 7).
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 added the impedance sensing system of Ganapathy, including the exposed ring electrodes, pad electrode, and the impedance analyzer, to the transseptal puncturing system of Davies for the purpose of allowing the user to accurately determine the position of the deflectable distal portion in order to avoid undesirable treatment outcomes such as puncturing/targeting undesirable tissue of the patient.
Regarding claims 10 and 20, Davies discloses the invention substantially as claimed in claims 1, 9, 11, and 19 discussed above.
However, Davies does not disclose a body patch, a navigation module configured to determine a position of the distal end of the microcatheter in a heart based at least in part on impedance between the body patch and the exposed electrode of the location sensor.
Ganapathy, in the same field of endeavor, teaches a surgical instrument including an impedance sensing system/navigation module for monitoring the position of the tip of the surgical instrument relative to the pericardial space (pa. 0042), wherein the surgical instrument includes two or more ring electrodes (202) mounted on the external surface of the instrument and a pad electrode/body patch (214) applicable to the skin of a patient. The ring electrodes and the pad electrode are connected to an impedance analyzer (226) (pa. 0075 & Figs. 7, 8) which includes at least one signal generating circuit (220) and at least one signal measuring circuit (222) which determines the impedance between the ring electrodes and the pad electrode (pa. 0076-0078) in order to calculate the position of the tip of the surgical instrument relative to the pericardial space.
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 added the navigation module of Ganapathy, including the ring electrodes, body patch electrode, and the impedance analyzer, to the transseptal puncturing system of Davies for the purpose of allowing the user to accurately determine the position of the deflectable distal portion in order to avoid undesirable treatment outcomes such as puncturing/targeting undesirable tissue of the patient.
Regarding independent claim 11, Davies discloses a transseptal puncturing system (50) (pa. 0132 & Figs. 1, 7c) comprising:
a steerable microcatheter comprising an elongated member (104) (pa. 0142) with a lumen extending therethrough to define a longitudinal axis (pa. 0046), a deflectable distal portion (100b) (pa. 0049 & Fig. 1A);
a guidewire (200) having a portion disposed in the lumen of the microcatheter (pa. 0083 & Fig. 5a), the guidewire comprising an electrically conductive core (204), an electrically conductive distal end (202, 208) (pa. 0084), an electrically conductive proximal end (206) (pa. 0124), and
However, Davies does not disclose a location sensor disposed proximate the deflectable distal portion, nor a navigation module configured to determine a position of the distal end of the microcatheter in a heart based at least in part on the location sensor in reference to the electrically conductive distal end of the guidewire.
Ganapathy, in the same field of endeavor, teaches a surgical instrument including an impedance sensing system/navigation module for monitoring the position of the tip of a guidewire relative to the pericardial space (pa. 0012, 0042). The navigation module comprises an impedance analyzer (226) (pa. 0075 & Figs. 7, 8) which includes at least one signal generating circuit (220) and at least one signal measuring circuit (222) which determines the impedance between multiple electrodes. The impedance values may be either directly displayed to an operator in the form of absolute impedance values (variable X) or in the form of relative impedance values (variable Y) which have been normalized by a reference value unique to the patient being operated (pa. 0042). The reference impedance values are collected at different locations on the patient using electrodes of the surgical instrument or other electrodes placed within the patient. The absolute impedance values may be normalized by the reference impedance values and expressed as an impedance ratio (X/Y). Impedance ratios within defined ranges may indicate the position of the tip of the surgical instrument, whether within the pericardial space, the intramural right ventricular space, or the anterior mediastinal space (pa. 0043-0044).
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 added the impedance sensing system of Ganapathy, including the impedance analyzer, to the transseptal puncturing system of Davies for the purpose of allowing the user to accurately determine the position of the deflectable distal portion in order to avoid undesirable treatment outcomes such as puncturing/targeting undesirable tissue of the patient.
Regarding claim 12, Davies/Ganapathy combination discloses wherein the guidewire comprises an outer diameter less than and approximately equal to an inner diameter of the lumen of the microcatheter (Davies, see Figs. 3A-3B).
Regarding claim 15, Davies/Ganapathy combination discloses a generator (500) in electrical contact with the electrically conductive proximal end (Davies, pa. 0047), the generator being configured to provide electrical energy to the distal end of the guidewire sufficient to puncture tissue (Davies, pa. 0084, 0103).
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Davies and Ganapathy as applied to claims 1 and 11 above, and further in view of Keaveney (U.S. Application No. 20180154155 A1).
Regarding claims 6 and 16, Davies/Ganapathy combination discloses an impedance monitoring module in communication with the generator, in electrical communication with the proximal end of the guidewire, and configured to measure impedance at the distal end of the guidewire (Ganapathy, pa. 0035, 0042-0045).
However, they do not teach wherein the generator is configured to provide the electrical energy to the distal end of the guidewire based at least in part on the measured impedance.
Keaveney, in the same field of endeavor, teaches a catheter device (100) comprising an elongated shaft (110, 122) with a lumen (128) extending therethrough to allow passage to a conductive guidewire (1210) (pa. 0046 & Figs. 1, 12). The catheter device further includes a plurality of energy delivery elements (124) mounted on the elongated shaft, wherein the energy delivery elements are configured to deliver constant power and/or monitor impedance (pa. 0031) in order to provide feedback that is used to adjust the amount of power delivered by a generator (1610) via a controller (1614) (pa. 0058-0059 & Fig. 16).
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 add the controller of Keaveney to the transseptal puncturing system of Davies and to have modified the functionality of the generator of Davies to incorporate the impedance monitoring functionality of the generator of Keaveney for the purpose of allowing the user to properly adjust the amount of power delivered to the tissue of the patient based on a feedback loop to avoid undesirable treatment outcomes.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Davies and Ganapathy as applied to claims 1 and 11 above, and further in view of Moak (U.S. Application No. 20200008883 A1).
Regarding claims 8 and 18, Davies/Ganapathy combination discloses the invention substantially as claimed in claim 1 discussed above.
However, they do not teach wherein the location sensor comprises a magnetic coil.
Moak, in the same field of endeavor, teaches an apparatus (100) coupled to a guidance system that uses magnetic-field sensor at a distal end (135) of the apparatus to detect the strength of magnetic fields generated by magnetic coils placed below or near the patient. The generated data is used to triangulate the position of the distal end of a needle (130) (pa. 0006, 0027 & Fig. 1).
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 substituted the impedance location sensor to be a magnetic coil since they are both known variants in the art and they would yield the same predictable results of facilitating position and monitoring of the location of the distal end of the microcatheter during a procedure.
Conclusion
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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