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 .
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.
Claim Rejections - 35 USC § 102
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 1-10, 12-14 and 17-31 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Highsmith et al. (US 2021/0401483).
Regarding claim 1, Highsmith discloses a system for accessing a left atrium through a septum (see Figs. 1-7B), comprising: an elongate member comprising a distal portion having a distal tip (see transseptal needle 110 and dilator 115 having a distal portion with distal tip 114, Fig. 3D), the distal tip configured to deliver energy for puncturing tissue during a tissue puncture procedure to access the left atrium through the septum (see [0065]-[0067], Figs. 3C-3E); and wherein the system is configured to: detect dielectric properties of a material in contact with the distal tip during the tissue puncture procedure (see impedance as a measure of dielectricity, [0066]); determine a change in the detected dielectric properties representative of a transition of the distal tip from contact with tissue to contact with blood to determine access of the distal tip into the left atrium (see change in impedance, [0067], entering the left atrium is considered to be a transition from contact with tissue to contact with blood in the left atrium, see [0048]); and automatically cease energy delivery based on determined access of the distal tip to the left atrium using the determined change in the detected dielectric properties (see [0052]-[0053]).
Regarding claim 2, Highsmith further discloses a sensor configured to determine a value of electrical current provided by the distal tip during the tissue puncture procedure, wherein the sensor is configured to detect the dielectric properties of the material in contact with the distal tip during the tissue puncture procedure using the determined value of electrical current (see [0051]).
Regarding claim 3, Highsmith further discloses a sensor configured to determine a value of impedance of the material in contact with the distal tip during the tissue puncture procedure (see processor detecting impedance of material in contact with the distal tip during the procedure, [0051] and [0053]), wherein the sensor is configured to detect the dielectric properties of the material in contact with the distal tip during the tissue puncture procedure, different than the determined value of impedance of the material, using the determined value of impedance (see detection of a change in impedance in [0053], which is different from the second impedance value detected in step 410 of Fig. 4 that is used to then determine the change in impedance).
Regarding claim 4, Highsmith further discloses a generator configured to provide the energy to the distal tip for puncturing tissue during the tissue puncture procedure, the generator configured to provide a voltage (see generator 180, [0051]); and a sensor configured to determine a value of an electrical property associated with the distal tip or the material in contact with the distal tip during the tissue puncture procedure, wherein the sensor is configured to detect the dielectric properties of the material in contact with the distal tip during the tissue puncture procedure using the determined value of the electrical property and the voltage provided by the generator (see the processing circuitry 182, [0051]).
Regarding claim 5, Highsmith further discloses a generator switch configured to automatically cease energy delivery based on the determined access of the distal tip to the left atrium using the determined change in the detected dielectric properties (see [0052]-[0053]).
Regarding claim 6, Highsmith further discloses wherein the generator switch includes a hardware switch responsive to the determined change in the detected dielectric properties and configured to cease energy delivery based on the determined change in the detected dielectric properties indicative of contact of the distal tip to blood (see [0052]-[0053], a hardware switch is implied since it would be required to break the electrical connection).
Regarding claim 7, Highsmith further discloses wherein the distal tip comprises an electrode (see ablation electrode 128, Figs. 3C-3E), wherein the system comprises a return electrode (see return pad 198, Fig. 1), wherein the system is configured to detect the dielectric properties of the material in contact with the distal tip during the tissue puncture procedure using the electrode of the distal tip and the return electrode (see [0051]-[0052]).
Regarding claim 8, Highsmith discloses a system for accessing a left atrium of a heart through a septum during a tissue puncture procedure (see Figs. 1-7B), comprising: a guidewire comprising a conductive core wire and a distal portion (see transseptal needle 110 and dilator 115 having a distal portion with distal tip 114, Fig. 3D) having an atraumatic distal tip (see Fig. 7B, [0092]); a generator configured to deliver to an electrode at the distal tip of the guidewire energy sufficient to aid in the puncture of the septum (see generator 180, [0065]-[0067], Figs. 1-3E); and a sensor system (see [0051]) configured to: detect electrical properties of a material in contact with the electrode during the tissue puncture procedure (see [0051]-[0052]); and measure a change in the detected electrical properties (see [0051]-[0052]); wherein the generator is configured to automatically stop the energy delivery based on the measured change in the electrical properties (see [0052]-[0053]).
Regarding claims 9-10 and 12-13, Highsmith further discloses the limitations of the claims under the same citations and rationale as applied in the rejections of claims 1, 3 and 7 above.
Regarding claim 14, Highsmith further discloses wherein the generator is configured to deliver radiofrequency (RF) energy (see [0044]).
Regarding claim 17, Highsmith further discloses wherein the guidewire includes a proximal end configured to be connected to the generator and a grounding pad electrically coupled to the generator with a return electrode and in contact with the patient's body to provide a return path for the energy delivered from the electrode (as shown in Fig. 1).
Regarding claims 18-20, Highsmith further discloses the limitations of the claims under the same citations and rationale as applied in the rejections of claims 1, 3 and 6-8 above.
Regarding claim 21, Highsmith discloses a system for accessing a left atrium of a heart through a septum (see Figs. 1-7B), comprising: a generator configured to provide energy for puncturing tissue during a tissue puncture procedure, wherein the generator is configured to provide a voltage (see generator 180, [0051]); a guidewire comprising a distal portion having an electrode at a distal tip (see transseptal needle 110 having a distal portion with distal tip 114, Fig. 3D), the electrode configured to deliver the energy to aid in puncturing the septum during the tissue puncture procedure (see [0047]); and a sensor system (see [0051]) configured to: measure a value of impedance of material in contact with the electrode or electrical current delivered by the electrode during the tissue puncture procedure (see measurement of second impedance at step 410, Fig. 4); compute dielectric properties of the material in contact with the electrode during the tissue puncture procedure using the measured value of impedance or electrical current, wherein the computed dielectric properties of the material are different than the measured value of impedance or electrical current (see computation of a change in impedance required determining an abrupt change has occurred for step 412, Fig. 4); and compute a change in the computed dielectric properties indicative of a transition of the electrode from contact with tissue to contact with blood (see determination of an abrupt change in impedance has occurred at step 412 which is indicative of the needle exiting tissue into blood, Fig. 4); and a generator switch configured to automatically stop the energy delivery based on the computed change in the dielectric properties (see [0052]-[0053]).
Regarding claims 22-30, Highsmith further discloses the limitations of the claims under the same citations and rationale as applied in the rejections of claims 1, 3 and 6-8 above.
Regarding claim 31, Highsmith further discloses wherein the conductive core wire comprises a distal taper portion (see tapered rounded end portion 114b with a gradual decrease in cross-sectional area in the proximal to distal direction as shown in Fig. 7B).
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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Highsmith in view of Hartley et al. (US 2004/0143261).
Regarding claim 15, Highsmith teaches the limitations of claim 14, however fails to specifically disclose wherein the generator is configured to deliver energy having a frequency in a range between 100 kHz and 1000 kHz.
Hartley teaches a transseptal puncture device using RF energy (see Figs. 1 and 7-9, [0046]), wherein energy is delivered as a continuous wave at a frequency between about 400 kHz and about 550 kHz using the BMC RF Perforation Generator (model number RFP-100, Baylis Medical Company, Montreal, Canada) which provides sinusoidal RF energy (see [0038]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the RF energy provided by the generator as disclosed by Highsmith to provide energy at a frequency in a range between 100 kHz and 1000 kHz in light of Hartley, the motivation being to provide the appropriate energy for a small functional tip in a high impedance range (see Hartley [0038]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Highsmith in view of Urbanski et al. (US 2014/0206987).
Regarding claim 16, Highsmith teaches the limitations of claim 14, however Highsmith fails to specifically disclose wherein the generator is configured to deliver a rectangular-wave, or a pulsed rectangular wave form.
Urbanski teaches a system for accessing a left atrium of the heart (see Figs. 8-9b) comprising an electrosurgical generator that is configured to deliver a rectangular-wave, or a pulsed rectangular wave (see [0124]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the generator as disclosed by Highsmith to be configured to deliver a rectangular-wave, or a pulsed rectangular wave form in light of Urbanski, the motivation being to provide the appropriate waveform that is suitable for perforating material within a patient’s body (see Urbanski [0124]).
Response to Arguments
Applicant's arguments filed 25 June 2026 have been fully considered but they are not persuasive.
To the extent applicant argues that Highsmith fails to disclose detecting, computing, or otherwise characterizing dielectric properties with respect to claims 1 and 3 (see Remarks pgs. 9-12), the examiner respectfully disagrees. Applicant argues that interpreting “dielectric properties” as impedance measurements is not consistent with the broadest reasonable interpretation in light of the specification. The instant specification describes reliance upon changes in electrical current to determine changes in impedance or dielectricity (see [0186]) as well as determining dielectricity by sending an electrical current of known voltage (see [0181]), however no specific definition for “dielectric properties” or “dielectricity” is set forth in the specification. Therefore, these claim terms are interpreted under their plain meaning as the ordinary and customary meaning given to the terms by those of ordinary skill in the electrical arts at the relevant time. Since impedance is a measure of electrical resistance, electrical resistance is equivalent in meaning to dielectric, and impedance can be reasonably measured using a supplied current of known voltage, the examiner contends that impedance and impedance changes are within the broadest reasonable interpretation of “dielectricity” and “dielectric properties” in light of the specification as one of ordinary skill in electrical concepts at the relevant time would recognize in the instant case consistent with MPEP 2111.01(I).
Applicant further argues a separation in described embodiments to distinguish impedance and dielectric properties as separate concepts, and that they reflect different underlying physical phenomena and operational roles (see Remarks pg. 10-11). However, the arguments fail to point out any actual difference in physical phenomena or operational roles in the specification. Figures 17A and 19A use impedance and dielectricity for the same operational roles. It is noted that the purported distinguishing features upon which applicant relies are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
To the extent that applicant argues inherency was not properly established with respect to the required “mechanical switch” of claim 6 (see Remarks pgs. 12-13), the examiner respectfully disagrees. The rejection above relies upon the automatic termination of ablation energy disclosed in [0052]-[0053] of Highsmith to support that a hardware switch being implied since it would be required to break the electrical connection (emphasis added). This meets the rationale and evidence required by MPEP 2112(IV) since this provides “a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art”. The arguments simply point out that the disclosure of Highsmith fails to explicitly disclose a hardware switch when the rejection was instead based on inherency, and fails to provide technical reasoning as to why a hardware switch would not necessarily flow from the disclosure relied upon or provide any different solution for how one of ordinary skill would implement such automatic energy termination without a mechanical switch to break the connection. Therefore, the rejection is maintained.
In response to applicant's argument that the references fail to show certain features of the invention (see Remarks pgs. 14-15 with respect to claim 8), it is noted that the features upon which applicant relies (i.e., a guidewire capable of being used as a puncturing device and guiderail) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In the instant case, the transseptal needle 112 forms a conductive core wire that guides dilator 150 over it, and [0092] of Highsmith explicitly discloses the distal portion as atraumatic, therefore the examiner contends that it meets the limitation of “a guidewire with a conductive core and a distal portion having an atraumatic tip”.
Additionally, applicant argues that the guidewire as disclosed in the instant specification “can be used, without exchange, as a puncturing device and a guide rail” and then also argues in the next paragraph that the atraumatic tip of Highsmith that serves a needle function in an ablation context is materially different from the claimed guidewire, when the guidewire as claimed and Highsmith’s needle 112 are materially and functionally the same since they both contain a conductive core, both have an atraumatic distal portion, and both function for puncturing and as a guide.
With regard to applicant’s arguments directed at claims 21 and 27, the claim mapping of claim 21, which also pertains to the corresponding limitations of claim 27, has been updated above in light of the amendments to the claim and does not appear to be specifically addressed in the current arguments, and contains issues that have already been addressed in the above responses.
Applicant’s argument with respect to claim 24 is believed to be fully addressed in the response to claim 6 above.
Applicant’s arguments with respect to claim 16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In the instant case, the new grounds of rejection rely on the newly cited Urbanski reference, which has not been addressed in the current arguments.
Applicant’s request for scheduling of an interview is acknowledged, however this interview request is denied since no issue that would advance prosecution could be identified at this time.
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 SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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