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 .
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.
Claim 2 is 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 2 recites the limitation "the pacing rate" instead of --a pacing rate-- in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6-9, 11-12, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0162210 A1 to Altmann et al. (hereinafter “Altmann”).
Regarding claims 1 and 12, Altmann teaches:
A system and method to perform reversible transvenous electroporation (see abstract and para [0029]),
the system and method comprising:
an electroporation generator (see para [0029] – “There is also provided in accordance with another embodiment of the present invention a electroporation system, including a catheter including multiple electrodes, and configured to be inserted into a chamber of a heart, a signal generator coupled to at least two of the electrodes, and configured to generate an electrical signal for supply to the at least two electrodes…..” and para [0036]);
And,
a controller/processing circuitry operably coupled to the electroporation generator (see fig. 1 – 41 & 34, para [0041], and para[0071]),
wherein the controller/processing circuitry is configured to:
instruct the electroporation generator to generate a voltage signal to perform electroporation, wherein the voltage signal has a predetermined range of voltages and a predetermined range of pulse widths to ensure that the electroporation is reversible, and
wherein the voltage signal is monophasic or biphasic (para [0074]),
and deliver the voltage signal to a catheter to perform the electroporation, wherein the catheter includes one or more electrodes through which the voltage signal is delivered (see para [0074] – “ The signal generator 34 (FIG. 1) is coupled to at least two of the electrodes 55 (FIG. 2) of the catheter 40. The signal generator 34 is configured to generate (block 64) an electrical signal for supply to at least two of the electrodes 55 which responsively to the electrical signal apply an electrical field to tissue of the chamber of the heart 26 at a given location within the chamber. The electrical field has an amplitude sufficient to cause reversible electroporation, but below a threshold for irreversible electroporation.”).
Regarding claims 6 and 16, Altmann teaches:
The system of claim 1 and the method of claim 12, wherein the catheter includes a plurality of spines/arms (see fig. 2 – 54 and para [0057]), and wherein each spine in the plurality of spines includes a plurality of electrodes (see fig. 2 – 54 and para [0058] – last sentence).
Regarding claims 7 and 17, Altmann teaches:
The system of claim 6 and the method of claim 16, wherein the plurality of electrodes on each spine alternate between positive and negative electrodes (see fig. 2 – 55 and para [0074] –“ The signal generator 34 (FIG. 1) is coupled to at least two of the electrodes 55 (FIG. 2) of the catheter 40. The signal generator 34 is configured to generate (block 64) an electrical signal for supply to at least two of the electrodes 55 which responsively to the electrical signal apply an electrical field to tissue of the chamber of the heart 26 at a given location within the chamber. …..The field may be applied between any two of the electrodes 55, for example, between adjacent electrodes 55, and/or between some of the electrodes 55 and a reference electrode of the electrodes 55.”).
Regarding claims 8 and 18, Altmann teaches
The system of claim 7 and the method of claim 17, wherein a first electrode of the plurality of electrodes receives the voltage signal and wherein a second electrode of the plurality of electrodes is a return path for the voltage signal (see para [0074] – “The signal generator 34 (FIG. 1) is coupled to at least two of the electrodes 55 (FIG. 2) of the catheter 40. The signal generator 34 is configured to generate (block 64) an electrical signal for supply to at least two of the electrodes 55 which responsively to the electrical signal apply an electrical field to tissue of the chamber of the heart 26 at a given location within the chamber. The electrical field has an amplitude sufficient to cause reversible electroporation, but below a threshold for irreversible electroporation. The field may be applied between any two of the electrodes 55, for example, between adjacent electrodes 55, and/or between some of the electrodes 55 and a reference electrode of the electrodes 55.”).
Regarding claim 9, Altmann teaches:
The system of claim 8, wherein the first electrode is adjacent to the second electrode (see fig. 2 – 55 and para [0074] – “The signal generator 34 (FIG. 1) is coupled to at least two of the electrodes 55 (FIG. 2) of the catheter 40……The field may be applied between any two of the electrodes 55, for example, between adjacent electrodes 55, and/or between some of the electrodes 55 and a reference electrode of the electrodes 55.”).
Regarding claims 11 and 20, Altmann teaches:
The system of claim 1 and the method of claim 12, wherein the controller limits the pulse duration of the voltage signal to 20 milliseconds or less to ensure that the electroporation is reversible (see para [0074] and para [0087] ).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 2-3 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann in view of US 2019/0060632 A1 to Asirvatham et al. (hereinafter “Asir”).
Regarding claims 2 and 13, Altmann teaches:
The system of claim 1 and the method of claim 12, but does not disclose further comprising a pacing system configured to generate a pacing signal, wherein the pacing rate is faster than a duration between pulses of the voltage signal.
However, Asir teaches systems and algorithms for delivering reversible electroporation pulses according to EKG/EGM monitoring (see abstract). The system (figs. 2B and fig. 6) teaches a pacing system configured to generate a pacing signal, wherein the pacing rate is faster than a duration between pulses of the voltage signal (see para[0002], para [0016], and para [0085]). The continuous pacing of the patient’s heart followed by applying one or more electroporation pulses when the heart is in a contracted state shows the pacing rate is faster than the duration between pulses of the voltage signal.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Altmann with the teachings of Asir to arrive at the claimed invention, since such combination would have led to a reasonable expectation for success and preserve the health and safety of the patient undergoing the electroporation procedure, due to the prior art showing that both pacing and electroporation to prevent unwanted heart rhythm side effects in the patient.
Regarding claims 3 and 14, Altmann as modified teaches:
The system of claim 2 and the method of claim 13, but does not disclose wherein the pacing system includes a pacing catheter to detect a heart pace of a patient upon which the electroporation is being performed.
However, Asir teaches wherein the pacing system includes a pacing catheter to detect a heart pace of a patient upon which the electroporation is being performed (see para [0045]- last sentence and para [0047]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Altmann with the teachings of Asir to arrive at the claimed invention, since such combination would have led to a reasonable expectation for success and preserve the health and safety of the patient undergoing the electroporation procedure, due to the prior art showing that both pacing and electroporation to prevent unwanted heart rhythm side effects in the patient.
Claim(s) 4, 5, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann in view of Asir, and further in view of US 2021/0145503 A1 to Pare et al. (hereinafter “Pare’”).
Regarding claim 4, Altmann as modified teaches:
The system of claim 3, but does not explicitly disclose wherein the system further comprises a pacing isolator in communication with the pacing catheter.
However, Pare’ teaches wherein protective device functions as a pacing isolator by synchronizing electrical isolation of the pacing device with the delivery of ablation energy by the ablation device (see fig. 4 – 230, 250, and 210, para [0035], para[0037], para [0044]).
Therefore, 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 system of Altmann to contain the pacing isolator system of Pare’ to arrive at the claimed invention. Such modification would lead to a reasonable expectation for success, since the prior art of Pare’ shows the use of the protection device/pacing isolator allowing for proper synchronization of electrical isolation of between the pacing system and the ablation energy delivery system, ultimately preserving patient safety during the therapeutic procedure.
Regarding claims 5 and 15, Altmann as modified teaches:
The system of claim 2 and the method of claim 13, but does not disclose wherein the pacing system uses a blanking period in combination with the pacing signal to control the duration between electroporation pulses.
However, Pare’ teaches wherein the pacing system uses a blanking period in combination with the pacing signal to control the duration between electroporation pulses (see figs. 7A-7B and para [0069]-[0072]).
Therefore, 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 system of Altmann to contain the blanking system of Pare’ to arrive at the claimed invention. Such modification would lead to a reasonable expectation for success, since the prior art of Pare’ utilizes this technique in order to properly synchronize the electroporation therapy with the cardiac cycle, ultimately preserving patient safety and providing optimal electroporation therapy.
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann in view of US 2012/0310230 A1 to Willis.
Regarding claims 10 and 19, Altmann teaches:
The system of claim 1 and the method of claim 12, wherein the controller limits the voltage signal to 450 V/centimeter (see para [0015] and para [0023]), but does not explicitly disclose wherein the controller limits the voltage signal to 300 Volts/centimeter or less to ensure that the electroporation is reversible.
However, Willis teaches a coaxial dual function probe (see abstract and fig. 1 ). The system ( fig. 1) teaches wherein the probe is configured to be used to produce reversible electroporation, specifically in the range of 1 V/cm- 300V/cm or more (see para [0120]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to obtain to optimal stimulation range of 300V/cm or less to produce effective reversible electroporation, since 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2020/0305946 A1 to DeSimone et al. teaches methods and devices for treating ventricular fibrillation through the use of reverse electroporation (see abstract and para [0036]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARMEL J WEBSTER whose telephone number is (703)756-5960. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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, NIKETA PATEL can be reached at 571-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.J.W./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights