DETAILED ACTION
The following is a 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/10/2025 has been entered.
Response to Amendment
There is no amendment filed with the RCE request. The Examiner called Applicant to inquire if an amendment would be submitted. Applicant confirmed that no new amendment would be filed (see Interview Summary of 11/26/2025).
Since no amendments were filed, the specification and claim objections are still outstanding.
Specification Objections
The disclosure is objected to because of the following informalities: amend “have been found” to -have found- in Pg. 6, ll. 26.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “biphasic electrical pulses” to -applying biphasic electrical pulses- in ll. 6. Appropriate correction is required. The Examiner notes that the absence of “applying” appears to be a typographical error between the claim sets as it was present in the previous claims of 7/20/2022.
Claim 5 is objected to because of the following informalities: amend “applying a train of the pulses” to -applying a pulse train- in ll. 2. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: amend “applying the train of the pulses” to -applying the pulse train- in ll. 1. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: amend “the sequence of pulse trains” to -the each of the pulse trains- in ll. 1. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: amend “in contact with” to -configured to be in contact with- in ll. 7. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: delete “contacted by the at least one probe electrode- in ll. 12. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: amend “apply a plurality of pulse trains” to -apply the pulse train, wherein the pulse train comprises a plurality of pulse trains, wherein the IRE generator is configured to apply the plurality of pulse trains- in ll. 2. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: amend “the sequence of the pulse trains” to -each of the plurality of pulse trains- in ll. 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5-11 & 14-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 10 recite the limitation “biphasic pulses with…a frequency of at least 500 kHz and less than 1 MHz”. The originally filed disclosure only provides support for: “a frequency of at least 500 kHz” (Pg. 6, ll. 6), “the frequency can be 1 MHz or more” (Pg. 6, ll. 9-10), “the inventors have been found that higher frequencies, in excess of 500 kHz” (Pg. 6, ll. 27), “IRE signal generator 38 that is capable of generating biphasic pulses at frequencies up to at least 1 MHz” (Pg. 8, ll. 11-12), “in order to achieve IRE pulse frequencies of 500 kHz or more” (Pg. 10, ll. 8-9, “a frequency of at least 500 kHz” (Pg. 11, ll. 11-12), “wherein the frequency is at least 1 MHz” (Pg. 11, ll. 18), “a frequency of at least 500 kHz” (Pg. 12, ll. 26). Thus, the originally filed disclosure fails to provide support for the newly amended limitation of “and less than 1 MHz”.
Claims 2, 5-9, 11 & 14-18 depend from claims 1 & 10 and are also thus rejected.
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) 1-2, 5-11 & 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Viswanathan et al. (2018/0085160, previously cited) in view of Gilbert (2017/0333109, previously cited) and Stewart et al. (2017/0035499, previously cited).
Concerning claim 1, as illustrated in at least Figs. 1, 3, 12A-B & 24, Viswanathan et al. disclose a method for medical treatment (method for electroporation ablation therapy; Abstract), comprising:
providing a probe configured for insertion into a heart of a living subject and comprising at least one probe electrode configured to contact myocardial tissue in the heart (electrode 1220 of an ablation device may be positioned around one or more of the ostia of the pulmonary veins 1210; [0191]);
providing at least one body-surface electrode, which is configured to be fixed to skin of the living subject (one or more return electrodes 140/1230 may be disposed on a skin of a patient; [0072-0073], [0192]); and
applying biphasic electrical pulses between the at least one probe electrode in contact with the myocardial tissue and the at least one body-surface electrode (return electrode 1230 may in turn receive a pulsed monophasic and/or biphasic waveform delivered by the electrode 1220; [0193]) with a peak-to-peak amplitude of at least 1 kV (amplitude of each pulse or the voltage amplitude of the biphasic pulse can be anywhere in the range from 500 volts to 7,000 volts or higher, including all values and sub ranges in between; [0231]), a frequency, wherein the frequency is configured to drive a current between the at least one probe electrode in contact with the myocardial tissue and the at least one body surface electrode and wherein the current is sufficient to cause irreversible electroporation of the myocardial tissue contacted by the at least one probe electrode (signal generator 122 is configured to generate pulse waveforms for irreversible electroporation that drives a current between the electrodes; [0073], [0082]).
Viswanathan et al. fail to disclose the frequency of the biphasic electrical pulses to be at least 500 kHz and less than 1 MHz. However, Gilbert discloses a method for medical treatment comprising applying biphasic electrical pulses between electrodes to cause irreversible electroporation, the pulses having a frequency from about 1,000 kHz to about 5,000 kHz, and in in certain embodiments from about 2,000 kHz to about 3,000 kHz ([0042]). 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 Viswanathan et al. such that the frequency of the biphasic electrical pulses is at least 500 kHz and less than 1 MHz in order to provide the benefit of inducing IRE in the tissue as taught by Gilbert et al. ([0042], [0044]). Further, as Applicant appears to have placed no criticality on the claimed range (“the frequency can be 1 MHz or more... The high frequency of the electrical excitation counteracts the low capacitance of the patient”), 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 Viswanathan et al. such that the frequency of the biphasic electrical pulses is at least 500 kHz and less than 1 MHz since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Viswanathan et al. in view of Gilbert et al. fail to specifically disclose the frequency configured to drive a current of at least 20 A between the electrode(s). However, Stewart et al. disclose an IRE generator applying high voltage and high current (20 or more amps) without long duration of electrical current flow that results in significant tissue heating and muscle stimulation. 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 Viswanathan et al. in view of Stewart et al. such that the frequency is configured to drive a current of at least 20 A between the electrode(s) in order to provide the benefit of avoiding significant tissue heating and muscle stimulation as taught by Stewart et al. ([0043])
Concerning claim 2, Viswanathan et al. disclose the peak-to-peak amplitude is at least 2 kV ([0231]; Fig. 24).
Concerning claim 5, Viswanathan et al. disclose applying the biphasic electrical pulses comprises applying a train (2410) of the pulses (2400) having a train duration that is less than 1 ms ([0232]). Further, it would have been obvious one of ordinary skill in the art to modify the invention of Viswanathan et al. in view of Gilbert et al. and Stewart et al. such that the train of pulses has a train duration that is less than 1 ms since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 6, Viswanathan et al. disclose applying the train (2410) of the pulses (2400) comprises applying a sequence (2420) of pulse trains (2410) with intervals (2412) between the pulse trains ([0231]; Fig. 24).
Concerning claim 7, Viswanathan et al. disclose the sequence (2420) of the pulse trains (2410) has an overall duration less than 250 ms ([0231]; Fig. 24). Further, it would have been obvious one of ordinary skill in the art to modify the invention of Viswanathan et al. in view of Gilbert et al. and Stewart et al. such that the pulse trains have an overall duration less than 250 ms since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Concerning claim 8, Viswanathan et al. disclose providing the at least one body-surface electrode (14/1230) comprises providing multiple body-surface electrodes (14/1230), which are fixed to the skin of the living subject at different, respective locations so that the current flows between the at least one probe electrode (1220) and the multiple body-surface electrodes (14/1230) ([0072-0073], [0192]; Fig. 12A-B).
Concerning claim 9, Viswanathan et al. disclose applying biphasic electrical pulses comprising synchronizing an application of the biphasic electrical pulses with a heart cycle of the living subject ([0196]; Fig. 25).
Concerning claim 10, as illustrated in at least Figs. 1, 3, 12A-B & 24, Viswanathan et al. disclose an apparatus for medical treatment (apparatus for electroporation ablation therapy; Abstract), comprising:
a probe configured for insertion into a heart of a living subject and comprising at least one probe electrode configured to contact myocardial tissue in the heart (electrode 1220 of an ablation device may be positioned around one or more of the ostia of the pulmonary veins 1210; [0191]);
at least one body-surface electrode, which is configured to be fixed to skin of the living subject (one or more return electrodes 140/1230 may be disposed on a skin of a patient; [0072-0073], [0192]); and
an IRE signal generator, which is configured to apply biphasic electrical pulses between the at least one probe electrode in contact with the myocardial tissue and the at least one body-surface electrode (signal generator 122 delivers pulsed monophasic and/or biphasic waveform to electrode 1220 which is then received by return electrode 1230; [0072-0073], [0193]) with a peak-to-peak amplitude of at least 1 kV (amplitude of each pulse or the voltage amplitude of the biphasic pulse can be anywhere in the range from 500 volts to 7,000 volts or higher, including all values and sub ranges in between; [0231]), a frequency, wherein the frequency is configured to drive a current between the at least one probe electrode in contact with the myocardial tissue and the at least one body surface electrode and wherein the current is sufficient to cause irreversible electroporation of the myocardial tissue contacted by the at least one probe electrode (signal generator 122 is configured to generate pulse waveforms for irreversible electroporation that drives a current between the electrodes; [0073], [0082]).
Viswanathan et al. fail to disclose the frequency of the biphasic electrical pulses to be at least 500 kHz and less than 1 MHz. However, Gilbert discloses a method for medical treatment comprising applying biphasic electrical pulses between electrodes to cause irreversible electroporation, the pulses having a frequency from about 1,000 kHz to about 5,000 kHz, and in in certain embodiments from about 2,000 kHz to about 3,000 kHz ([0042]). 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 Viswanathan et al. such that the frequency of the biphasic electrical pulses is at least 500 kHz and less than 1 MHz in order to provide the benefit of inducing IRE in the tissue as taught by Gilbert et al. ([0042], [0044]). Further, as Applicant appears to have placed no criticality on the claimed range (“the frequency can be 1 MHz or more... The high frequency of the electrical excitation counteracts the low capacitance of the patient”), 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 Viswanathan et al. such that the frequency of the biphasic electrical pulses is at least 500 kHz and less than 1 MHz since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Viswanathan et al. in view of Gilbert et al. fail to specifically disclose the frequency configured to drive a current of at least 20 A between the electrode(s). However, Stewart et al. disclose an IRE generator applying high voltage and high current (20 or more amps) without long duration of electrical current flow that results in significant tissue heating and muscle stimulation. 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 Viswanathan et al. in view of Stewart et al. such that the frequency is configured to drive a current of at least 20 A between the electrode(s) in order to provide the benefit of avoiding significant tissue heating and muscle stimulation as taught by Stewart et al. ([0043])
Claim 11 is rejected upon the same rationale as provided for claim 2.
Claim 14 is rejected upon the same rationale as provided for claim 5.
Claim 15 is rejected upon the same rationale as provided for claim 6.
Claim 16 is rejected upon the same rationale as provided for claim 7.
Claim 17 is rejected upon the same rationale as provided for claim 8.
Claim 18 is rejected upon the same rationale as provided for claim 9.
Response to Arguments
No arguments were submitted with the RCE.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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 on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794