DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/5/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 2/5/2026.
Applicant’s amendments to and/or cancellation of claims are sufficient to overcome the claim objections set forth in the previous office action.
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, 3, 5-7, 9, 11, 13-14 & 17-18 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.
Claim 1 recites the limitation “the thickness being identified to reduce the electrical impedance during application of the biphasic electrical pulses to the biological tissue at the specified pulse frequency of 100 kHz or more by at least 25% relative to a baseline impedance between the metal electrode and the biological tissue in absence of the ceramic coating”. The phrase “at least 25%” is regarded as indefinite as it is not bounded by an upper range and there is no disclosure of an upper range bound in the originally filed disclosure and claim 9 recites the limitation “a ceramic coating disposed over the metal electrode with a thickness selected so as to reduce an electrical impedance between the metal electrode and the biological tissue at the specified pulse frequency of 100 kHz or more at least 25% relative to a baseline impedance between the metal electrode and the biological tissue in absence of the ceramic coating.”
Claims 1 & 9 both recite “a baseline impedance between the metal electrode and the biological tissue in absence of the ceramic coating”. Since the “baseline impedance” is never defined and depends on multiple parameters (frequency, type of tissue, etc.), the term “baseline impedance” is regarded as indefinite.
Claims 3, 5, 7, 9, 11, 13-14 & 17-18 depend from claims 1 & 9 and are thus also rejected.
Claim Interpretation
Claims 1 & 9 both recite “a specified pulse frequency of 100 kHz or more” which is not regarded as an indefinite unbounded range since the method and system both recite the pulses cause electroporation pulses and thus, the frequency range is bounded on the upper end by the electroporation frequency range.
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.
Claim(s) 1, 3, 6-7 & 17-18 is/are rejected under 35 U.S.C. 102 as being anticipated by Pederson et al. (2024/0138736, with support in PCT/US2022/018199 and provisional 63/156030).
Concerning claims 1 & 18, Pederson et al. discloses, in various embodiments illustrated in Figs. 1-15, a method for fabricating a medical device (method of making a catheter; [0007]), the method comprising:
providing a metal electrode to be used in applying biphasic electrical pulses having an applied voltage of up to 2000 volts to biological tissue, thereby causing irreversible electroporation of the biological tissue (electrode 108/208/450 can be used for a variety of diagnostic and therapeutic purposes including, for example and without limitation, cardiac mapping and/or ablation (e.g., RF ablation or Irreversible Electroporation (IRE ablation)/Pulsed Field Ablation (PFA) with ablation generator 122 where the electrode is capable of applying the biphasic electrical pulses at an applied voltage of up to 2000 volts; [0039]);
identifying a thickness of a ceramic coating to be applied to the metal electrode that will reduce an electrical impedance between the metal electrode and the biological tissue by a specified amount (impedance reduction layer 209/458 can be used to reduce the impedance of the electrodes 108/450 and can be either of iridium oxide, indium tin oxide (ITO); [0047-0048], [0060-0061], [0063], [0066]) when the biphasic electrical pulses are applied to the biological tissue at a specified pulse frequency, the thickness being identified to reduce the electrical impedance during application of the electrical pulses to the biological tissue at the specified pulse frequency relative to a baseline impedance between the metal electrode and the biological tissue in absence of the ceramic coating; depositing the ceramic coating over the metal electrode to the identified (where the thickness is determined in relation to the electrode and can be preferably between 1-5 microns (1000-5000 nm); [0047], [0055],[0060-0061], where Applicant’s disclosure states an iridium oxide thickness of between 100 and 10,000 nm provides the claimed impedance reduction in Par. [0049]); and
assembling the metal electrode onto a probe for application to the biological tissue (electrodes 108/208/450 can be attached to shaft 204; [0048]).
Concerning claim 3, Pederson et al. disclose the probe comprises a catheter and assembling the metal electrode comprises fixing the metal electrode to a distal end of the catheter for insertion into a heart of a living subject comprising the biological tissue, such that the metal electrode is configured to contact the biological tissue of the heart ([0048]).
Concerning claim 6, Pederson et al. disclose identifying the thickness comprises selecting the thickness within a range between 100 and 10,000 nm ([0055]).
Concerning claim 7, Pederson et al. disclose depositing the ceramic coating comprises applying a process of electrochemical deposition or physical vapor deposition to the metal electrode ([0055]).
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(s) 9, 11, 14 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson et al. (2024/0138736, with support in PCT/US2022/018199 and provisional 63/156030), as applied to claim 1, in further view of Viswanathan et al. (2018/0311497, previously cited).
Concerning claim 9, Pederson et al. discloses, in various embodiments illustrated in Figs. 1-15, a system for medical treatment (system 100; [0030]), the system comprising:
a signal generator, which is configured to generate biphasic electrical pulses having an applied voltage of up to 2000 V and at a specified pulse frequency of 100 kHz or more to cause irreversible electroporation of biological tissue (ablation generator 122 can be configured for electroporation/PFA; [0039]);
Pederson et al. fail to disclose the specifics of the ablation generator. However, Viswanathan et al. disclose a system for medical treatment comprising an electroporation ablation generator configured to deliver a set of biphasic IRE voltage pulse waveforms having an applied voltage of up to 2000 volts to ablate tissue and electrically isolate one or more regions of tissue at a frequency range of 500 Hz-500kHz. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Pederson et al. such that the electroporation ablation generator is configured to deliver a set of biphasic IRE voltage pulse waveforms to ablate tissue and electrically isolate one or more regions of tissue at a frequency range of 500 Hz-500kHz in order to provide the benefit of delivering electroporation energy to ablate issue depending on the clinical application as taught by Viswanathan et al. ([0039-0040], [0045], [0047], [0177])
a probe comprising a metal electrode, which is configured to be applied to the biological tissue and is coupled to receive the biphasic electrical pulses from the signal generator (catheter comprises electrode 108/208/450 can be used for a variety of diagnostic and therapeutic purposes including, for example and without limitation, cardiac mapping and/or ablation, and is capable of receiving biphasic electrical pulses; [0039]); and
a ceramic coating disposed over the metal electrode (impedance reduction layer 209/458 can be used to reduce the impedance of the electrodes 108/450 and can be either of iridium oxide, indium tin oxide (ITO); [0047-0048], [0060-0061], [0063], [0066]) with a thickness selected so as to reduce an electrical impedance between the metal electrode and the biological tissue at the specified pulse frequency of 100 kHz or more by at least 25% relative to a baseline impedance between the metal electrode and the biological tissue in absence of the ceramic coating (where the thickness is determined in relation to the electrode and can be preferably between 1-5 microns (1000-5000 nm); [0047], [0055],[0060-0061], where Applicant’s disclosure states an iridium oxide thickness of between 100 and 10,000 nm provides the claimed impedance reduction in Par. [0049]).
Claim 11 is rejected upon the same rationale as applied to claim 3.
Claim 14 is rejected upon the same rationale as applied to claim 6.
Claim 18 is rejected upon the same rationale as applied to claim 17.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson et al. (2024/0138736, with support in PCT/US2022/018199 and provisional 63/156030), as applied to claim 1, in further view of Beeckler et al. (2019/0111233, previously cited).
Concerning claim 5, Pederson et al. fail to disclose the ceramic coating comprises titanium nitride. However, Beeckler et al. disclose a method for fabricating a medical device comprising depositing a ceramic impedance reduction coating over a metal electrode, the coating comprising iridium oxide or titanium nitride ([0007], [0020]). It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Pederson et al. such that the ceramic coating comprises titanium nitride since Beeckler et al. teaches iridium oxide and titanium nitride to be equivalents in the art for the purposes of impedance reduction coatings, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pederson et al. (2024/0138736, with support in PCT/US2022/018199 and provisional 63/156030) in view of Viswanathan et al. (2018/0311497, previously cited), as applied to claim 9, in further view of Beeckler et al. (2019/0111233, previously cited).
Claim 13 is rejected upon the same rationale as applied to claim 5.
Response to Arguments
The Examiner clarified the claim interpretation in the section above.
Applicant's arguments are moot in view of the new ground(s) of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Moaddeb (6,475,214) teaches a titanium nitride electrode coating.
Long et al. (2020/0093539) teaches electroporation electrode(s) having a biocompatible coating that permits capacitive voltage delivery with biphasic waveforms.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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