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 Amendment
The amendment filed 24 September 2025 has been entered. Claims 1, 12, and 20 are currently amended. Claims 2-3 and 13-14 were previously canceled, and claims 1, 4-10, and 11 were previously withdrawn. Claims 1, 4-12, and 15-24 are pending in the application.
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 12 and 15-24 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.
The term “adequacy of perforation” in claims 12 and 20 is a relative term which renders the claims indefinite. The term “adequacy of perforation” 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. Accordingly, it is unclear whether the predetermined time indicates that the cardiac tissue or fossa ovalis is or is not perforated. For examination purposes, the claims will be read as wherein, if the measured electrical impedance does not indicate complete perforation, the predetermined time defines a timeout condition for automatically terminating the outputting of ablation energy to the ablation electrode when the predetermined time is elapsed.
Claim 20 as amended recites the limitation "the measured electrical impedance" in line 25. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends changing earlier instances of “the electrical impedance” to --the measured electrical impedance--.
Dependent claims 15-19 and 21-24 are necessarily rejected as depending upon rejected base claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shah et al. (US Patent No. 6,565,562), hereinafter Shah, in view of Heckel et al. (US PGPub No. 2016/0081740), hereinafter Heckel, and further in view of Falkenstein et al. (US PGPub No. 2009/0248022), hereinafter Falkenstein.
Regarding claim 12, Shah teaches a method for controlling an RF transseptal needle and performing a transseptal perforation procedure (col 1, lines 18-21: “the invention is directed to a perforation guidewire which can be energized by radio frequency current to first create, and then enlarge, in a controlled manner, a hole in the atrial septum”), the method comprising:
measuring impedance and starting ablation once the ablation electrode is in contact with tissue (col 3, lines 58-61: “When the RF generator is first turned on, and the guidewire is in contact with the tissue that needs to be perforated, an impedance value is measured and stored”),
setting a start time from which the elapse of time is measured such that the start time is based on starting ablation, which only occurs when the ablation electrode is in contact with tissue (col 7, lines 13-15: “Now the RF output is active and the on/off switch 19 is illuminated green. The timer display 21 counts up from 0 to the set time;” examiner interprets starting the timer as setting a start time from which the elapse of time is measured),
outputting ablation energy to an ablation electrode of the transseptal needle (col 7, lines 8-13: “The RF generator 2 now is ready to energize electrically the tip 14 via the guidewire 7, removable connection terminal 6, connecting cable 5, and the connection terminal 4 of RF generator 2. The ON mode is initiated when the user depresses the on/off switch 19. Now the RF output is active”) such that the ablation energy is output from the ablation electrode from the start time until being automatically terminated (col 7, lines 15-16: “RF output is terminated and the mode changes to the DONE […] mode when the timer elapses”);
measuring an electrical impedance through the ablation electrode (claim 5: “further comprising measuring an impedance of said tip”) while outputting ablation energy to the ablation electrode (col 3, lines 63-66: “As the guidewire advances through the tissue, impedance will rise by about 20% and then level off, and this will be monitored and stored by the microprocessor;” col 7, lines 28-31: “once the RF generator 2 is activated, it will deliver the power level set consistently to the tip 14 in contact with the appropriate tissue over the full duration set;” examiner notes that since power is delivered consistently while the guidewire is advanced, and impedance is measured while the guidewire is advance, impedance must be measured while outputting ablation energy to the ablation electrode);
detecting a tissue impedance comprising the electrical impedance through the ablation electrode while the ablation electrode is positioned within cardiac tissue (col 3, lines 58-61: “When the RF generator is first turned on, and the guidewire is in contact with the tissue that needs to be perforated, an impedance value is measured and stored”);
and measuring an elapse of time to determine whether a predetermined time is elapsed (col 4, lines 16-19: “At the top left hand area is located the time setting switches and digital display 21 which allow the user to set the duration of the usage of the unit” and col lines 3-15: “In the READY mode, the power level 20 and the count-up timer 21 are settable […] The timer display 21 counts up from 0 to the set time”).
Shah is silent with respect to the specific means by which tissue contact is determined and does not explicitly teach measuring a pre-contact impedance through the ablation electrode when the ablation electrode is positioned outside of cardiac tissue and detecting a change in the impedance through the ablation electrode from the pre-contact impedance to the tissue impedance, wherein the start time corresponds to a time at which the change in impedance is detected; or automatically terminating the outputting of ablation energy to the ablation electrode when the measured electrical impedance through the ablation electrode increases by a predetermined impedance difference from the tissue impedance, the predetermined impedance difference indicating that the ablation electrode is not in contact with tissue. However, in a related electrosurgical art, Heckel teaches measuring a pre-contact impedance comprising the electrical impedance through an ablation electrode when the ablation electrode is positioned outside of tissue (Fig. 4 and pars. 0085-0086: “electrosurgical system 410 may sense (at 424), through electrode tines 418 and 422 (that make up, or form, output port 408 of output circuit 420), an output impedance, Zout […] Electrosurgical device 402 may, at other times, not touch bodily organ or tissue 404, in which case electrosurgical system 410 is to, theoretically, sense (at 424) an output impedance, Zout, that is infinitely high (428);” see also Fig. 8 and par. 0112: “a ‘start impedance’, Zstart, threshold value that may be, for example, 2.2 KΩ”)
and detecting a change in the impedance through the ablation electrode from the pre-contact impedance to the tissue impedance (Fig. 8: time t62; par. 0112: “According to the example of FIG. 8, at time t62 it may be determined that the therapeutic device controlled by the electrosurgical system touches an organ or tissue. (The determination may be made if the value of the monitored output impedance is, in this example, lower than a ‘start impedance’, Zstart, threshold value that may be, for example, 2.2 KΩ)”)
and wherein the start time corresponds to a time at which the change in impedance is detected (Fig. 8: tissue contact and energy delivery both occurring at time t62; par. 0112: “at time t62 it may be determined that the therapeutic device controlled by the electrosurgical system touches an organ or tissue. […] Therefore, the signal generator may start delivering therapeutic energy (850) to the tissue at time t62”),
and a predetermined impedance increase indicates that the ablation electrode is not in contact with tissue (Fig. 8 and par. 0112: “At time t63, it is determined that the therapeutic device does not touch the organ or tissue. (The determination may be made if the value of the monitored instantaneous output impedance is, in this example, greater than a ‘stop impedance’, Zstop, threshold value that may be, for example, 3.5 KΩ)”);
wherein ablation energy can be automatically stopped and started based on whether tissue contact is detected (Fig. 8 and pars. 0112-0113: “the signal generator stops delivering the therapeutic energy (860) to the tissue at time t63. At time t64, tissue contact is detected again (through monitoring of the instantaneous output impedance). (The determination is made if the value of the monitored instantaneous output impedance is, again, lower than the start impedance threshold value, Zstart.) Therefore, the signal generator restarts delivering therapeutic energy (870) to the tissue at time t64”).
To modify the method of the combined reference with impedance-based tissue detection, an ablation start time corresponding to the time of tissue detection, and automatic termination when a predetermined impedance increase indicates that the ablation electrode is not in contact with tissue, as taught by Heckel, would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the following reasons:
Shah teaches a prior art electrosurgical method upon which the claimed method, which uses impedance to detect tissue contact, may be seen as an improvement (Shah is silent with respect to the means by which tissue contact is determined and does not teach automatic termination of ablation energy after an indication that the ablation electrode is not in contact with tissue). Heckel teaches a prior art electrosurgical method using a known technique that is applicable to the method of the combined reference, namely, the technique of using impedance to detect whether the ablation electrode is in contact with tissue before applying ablation energy, immediately applying ablation energy once tissue contact is detected, and automatically stopping ablation energy once tissue contact is lost. Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Heckel to the method of the combined reference would have yielded predictable results and resulted in an improved method, namely, a method that uses impedance to detect whether the ablation electrode is in contact with tissue, based on the fact that tissue contact has a lower impedance than a threshold impedance outside of tissue, and automatically delivers ablation energy at the time of tissue contact and terminates ablation energy when an increase in impedance indicates loss of contact, so that ablation energy can be automatically stopped and started based on whether tissue contact is detected.
Shah in view of Heckel further teaches that a timeout can be used to prevent overheating the tissue (Heckel at par. 0108: “If timeout is reached, this means that the electrosurgical device should be removed from the treated site in order not to overheat the treated tissue/organ”), but the combination does not explicitly teach wherein, in response to the measured electrical impedance through the ablation electrode not increasing by the predetermined impedance difference from the tissue impedance, measuring an elapse of time from the start time to determine whether a predetermined time is elapsed, the predetermined time defining a timeout condition; and automatically terminating the outputting of ablation energy to the ablation electrode when the predetermined time is elapsed.
However, in an analogous art, Falkenstein teaches an electrosurgical method with end point determination to automatically halt the application of energy to tissue (Fig. 40 and par. 0270: “The tool applies energy 603, e.g., RF energy, and continues until an endpoint is reached or an error condition is detected. Upon determination of an endpoint being reached or exceeded 604, the tool is deactivated (e.g., application of energy is stopped)”), wherein the elapse of a predetermined time defining a timeout condition results in automatically terminating the output of ablation energy even when the end point is not reached (par. 0272: “timeout parameters, e.g., a timer or counter reaching or exceeding a set time limit, or a fault condition stops or interrupts the process even if the determined end point is not reached or exceeded”).
To provide the method of the combined reference with a timeout parameter, as taught by Falkenstein, would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, because one of ordinary skill in the art would have recognized that applying the known technique used by the method of Falkenstein (using a timeout parameter to stop or interrupt the process even if an end point is not reached) to the method of the combined reference would have yielded predictable results and resulted in an improved method, namely, a method that automatically terminates delivery of ablation energy after a timeout period elapses without reaching the impedance end point, in order to prevent overheating of the tissue.
Regarding claim 18, the combination teaches the method of claim 12 as described previously. Shah further teaches further comprising: determining a fossa ovalis is perforated based on the electrical impedance through the ablation electrode (col 4, lines 5-8: “When the tip of the guidewire has perforated through the tissue, and is on the other side, impedance will drop by 20% or more, and this is the signal to the microprocessor to shut off the generator”); and providing an indication that the fossa ovalis is perforated (col 7, lines 15-16: “RF output is terminated and the mode changes to the DONE mode;” examiner interprets the microprocessor shutting off the generator in DONE mode as providing an indication that the fossa ovalis is perforated).
Regarding claim 19, the combination teaches the method of claim 12 as described previously. Shah further teaches providing an indication that the timer has elapsed and/or that an error is detected (Fig. 9: fault display light on generator interface; col 7, lines 13-18: “Now the RF output is active and the on/off switch 19 is illuminated green. The timer display 21 counts up from 0 to the set time. RF output is terminated and the mode changes to the DONE (or FAULT) mode when the timer elapses, when the RF on/off switch 19 is pressed during the ON mode, or when an error is detected”) but does not explicitly teach determining that a fossa ovalis is incompletely perforated based on the elapse of the predetermined time.
However, in light of Falkenstein, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to determine that the electrosurgical process of Shah (perforating a fossa ovalis) is incomplete based on the elapse of the predetermined time, as taught by Falkenstein, since Falkenstein teaches that the timeout parameter may interrupt the process even when the end point is not reached (i.e., when the surgical process is incomplete).
Regarding claim 20, Shah teaches a method of performing a transseptal perforation procedure (col 1, lines 18-21: “the invention is directed to a perforation guidewire which can be energized by radio frequency current to first create, and then enlarge, in a controlled manner, a hole in the atrial septum”), the method comprising:
contacting a fossa ovalis with a tip of a transseptal needle comprising an ablation electrode thereon (col 2, lines 32-34: “an electrically conductive exposed tip for creating a perforation when RF current is applied” and claim 1: “advancing said instrument to contact a wall of said body tissue to be perforated”);
setting a start time based on detection of contact of the tip with the fossa ovalis and initiation of ablation energy to the ablation energy (col 7, lines 13-15: “Now the RF output is active and the on/off switch 19 is illuminated green. The timer display 21 counts up from 0 to the set time;” examiner notes that starting ablation only occurs when the ablation electrode is in contact with tissue, and interprets starting the timer as setting a start time from which the elapse of time is measured);
electrically ablating the fossa ovalis with the ablation electrode (col 7, lines 8-13: “The RF generator 2 now is ready to energize electrically the tip 14 via the guidewire 7, removable connection terminal 6, connecting cable 5, and the connection terminal 4 of RF generator 2. The ON mode is initiated when the user depresses the on/off switch 19. Now the RF output is active”) such that the ablation energy is output from the ablation electrode from the start time until being automatically terminated (col 7, lines 15-16: “RF output is terminated and the mode changes to the DONE […] mode when the timer elapses”);
penetrating the fossa ovalis while electrically ablating the fossa ovalis (col 7, lines 19-25: “Moderate pressure must be applied to the guidewire 7 in the distal direction to cause it to perforate a hole […] It is important that constant longitudinal forward force be exerted during the delivery of the RF current to advance the tip 14 to create the adequate passageway required”);
measuring an electrical impedance through the ablation electrode (claim 5: “further comprising measuring an impedance of said tip”) while electrically ablating the fossa ovalis with the ablation electrode (col 3, lines 63-66: “As the guidewire advances through the tissue, impedance will rise by about 20% and then level off, and this will be monitored and stored by the microprocessor;” col 7, lines 28-31: “once the RF generator 2 is activated, it will deliver the power level set consistently to the tip 14 in contact with the appropriate tissue over the full duration set;” examiner notes that since power is delivered consistently while the guidewire is advanced, and impedance is measured while the guidewire is advance, impedance must be measured while outputting ablation energy to the ablation electrode);
detecting a tissue impedance comprising the electrical impedance through the ablation electrode while the ablation electrode is positioned within tissue of the fossa ovalis (col 3, lines 58-61: “When the RF generator is first turned on, and the guidewire is in contact with the tissue that needs to be perforated, an impedance value is measured and stored”);
and measuring an elapse of time to determine whether a predetermined time is elapsed (col 4, lines 16-19: “At the top left hand area is located the time setting switches and digital display 21 which allow the user to set the duration of the usage of the unit” and col lines 3-15: “In the READY mode, the power level 20 and the count-up timer 21 are settable […] The timer display 21 counts up from 0 to the set time”).
Shah does not specifically teach the start time corresponding to a time at which the contact of the tip with the fossa ovalis is detected; or automatically terminating the outputting of ablation energy to the ablation electrode when the measured electrical impedance through the ablation electrode increases by a predetermined impedance difference from the tissue impedance, the predetermined impedance difference indicating that the ablation electrode is not in contact with tissue. However, Heckel teaches wherein a start time for ablation corresponds to a time at which contact with tissue is detected (Fig. 8: tissue contact and energy delivery both occurring at time t62; par. 0112: “at time t62 it may be determined that the therapeutic device controlled by the electrosurgical system touches an organ or tissue. […] Therefore, the signal generator may start delivering therapeutic energy (850) to the tissue at time t62”),
and a predetermined impedance increase indicates that the ablation electrode is not in contact with tissue (Fig. 8 and par. 0112: “At time t63, it is determined that the therapeutic device does not touch the organ or tissue. (The determination may be made if the value of the monitored instantaneous output impedance is, in this example, greater than a ‘stop impedance’, Zstop, threshold value that may be, for example, 3.5 KΩ)”);
wherein ablation energy can be automatically stopped and started based on whether tissue contact is detected (Fig. 8 and pars. 0112-0113: “the signal generator stops delivering the therapeutic energy (860) to the tissue at time t63. At time t64, tissue contact is detected again (through monitoring of the instantaneous output impedance). (The determination is made if the value of the monitored instantaneous output impedance is, again, lower than the start impedance threshold value, Zstart.) Therefore, the signal generator restarts delivering therapeutic energy (870) to the tissue at time t64”).
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 method of the combined reference by configuring the start time corresponding to a time at which contact with tissue is detected and automatically terminating ablation energy when an increase in impedance indicates loss of contact, as taught by Heckel, so that ablation energy can be automatically stopped and started based on whether tissue contact is detected, as taught by Heckel.
For the same reasons laid out previously in the rejection of claim 12, the combined reference in view of Falkenstein further teaches wherein, in response to the measured electrical impedance through the ablation electrode not increasing by the predetermined impedance difference from the tissue impedance, measuring an elapse of time from the start time to determine whether a predetermined time is elapsed, the predetermined time defining a timeout condition; and automatically terminating the outputting of ablation energy to the ablation electrode when the predetermined time is elapsed.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Heckel and Falkenstein and further in view of Govari (US Patent No. 6,484,118).
Shah in view of Heckel and Falkenstein teaches the method of claim 12 as described previously. The combination does not teach determining, via a magnetic sensor of the transseptal needle, a position of the transseptal needle in relation to a fossa ovalis, or providing computer readable coordinates of the position of the transseptal needle in relation to the fossa ovalis. However, Govari, in an analogous device, teaches determining the position of a medical device via a magnetic sensor (col 1, line 61 - col 2, line 22) and providing computer readable coordinates of the position of the transseptal needle in relation to the fossa ovalis (col 8, lines 47-49: “Signal processor 25 (FIGS. 1 and 2) determines three positions (X, Y, and Z) and two orientation (pitch and yaw) coordinates of sensing coil 26 by the method described herein;” Figs. 1-2: computer 21, signal processor 25).
To incorporate computer readable magnetic position determination into the method of the combined reference would have been obvious to one of ordinary skill in the art, in view of the teachings of Govari, since all the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, before the effective filing date of the claimed invention, i.e., one skilled in the art would have recognized that the magnetic position determination of Govari would allow for no-contact position tracking by computer of the transseptal needle in relation to the fossa ovalis, which would facilitate positioning the needle correctly and avoiding unintended injury.
Claims 17 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Shah in view of Heckel and Falkenstein and further in view of Davies et al. (US PGPub No. 2016/0058504), hereinafter Davies.
Shah in view of Heckel and Falkenstein teaches the methods of claims 12 and 19-20 as described previously. The combination does not explicitly teach wherein the predetermined time is about 1 millisecond to about 10 milliseconds. However, in related electrosurgical puncturing art, Davies teaches puncturing through cardiac tissue using energized pulses of 5 milliseconds (par. 0060: “The time period τ of a pulse may range from about 5 ms (milliseconds) to about 1 second. Examples of the pulse time period τ of some embodiments are 5 ms, 25 ms, 100 ms, 300 ms or 1 second”) and that puncture time varies depending on the thickness of the tissue and the voltage applied to the tissue (par. 0070: “the time for a puncture to occur will vary depending on the pericardial thickness of the patient being treated. Furthermore, puncture time varies depending upon the voltage applied to the tissue”). Additionally, Davies teaches that delivering energy in a short duration adds a measure of safety during the puncture procedure (par. 0058: “The short duration of energy delivery adds a measure of safety”). Examiner notes that although Davies’ application of energy is pulsed (see Fig. 6: two pulses 34), the total time of two pulses is still considered to fall within the scope of the claimed range (two pulses at a pulse period of 5 milliseconds results in a total time of about 10 milliseconds), and the claim language does not preclude pulsed application of energy.
In light of the teachings of Davies that a short duration of energy delivery adds a measure of safety to a cardiac puncture procedure, 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 method of the combined reference by selecting a predetermined time of about 1 millisecond to about 10 milliseconds when appropriate for a septal puncture procedure, since Davies teaches a range of energy delivery durations overlapping with the claimed range and that puncture time necessarily varies depending on the thickness of the tissue and the voltage applied, and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant’s arguments, filed 24 September 2025, with respect to the rejection(s) of claim(s) 12 and 20 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, in light of the amendments to the claims, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Falkenstein. As described previously, Falkenstein teaches a timeout parameter for automatically stopping the delivery of ablation energy when the end point for a surgical process is not reached.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LINDA C DVORAK can be reached at 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./ Examiner, Art Unit 3794