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 .
Specification
The amendment filed 5/2/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Pages 1, 2, 18, and 29 have added new matter because the amendments have occurred after the original filing date. The examiner notes MPEP 1893.03(b) discloses “[a]n international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application. Therefore, the filing date is 10/09/2023 and the amendments on 5/2/2025, including the incorporation by reference statement on page 1, introduces new matter. MPEP 608.01(p)(1)(B) discloses an incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C.132(a)).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 3 is objected to because of the following informalities: the last line states “designed as shock coil” this should state “designed as a shock coil”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-8, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mouchawar (US Patent 6,535,762) in view of Weerakoon et al (US Publication 2023/0173273).
Referring to Claim 1, Mouchawar teaches implantable cardioverter-defibrillator comprising: a housing, wherein the housing comprises a stimulation unit and a sensing unit (e.g. Figures 4A-4B housing 52); a combined defibrillation and sensing electrode for delivering stimulation pulses to a patient in need thereof and for sensing electrocardiogram signals of the same patient, wherein the combined defibrillation and sensing electrode is electrically connected to the stimulation unit and to the sensing unit (e.g. Figure 4A, Element 56, abstract, and Column 3 lines 24-28 discloses the present invention advantageously integrates pacing/sensing, shocking into a single electrode); wherein the combined defibrillation and sensing electrode comprises an electrode pole that serves for delivering stimulation pulses to a patient in need thereof and for sensing electrocardiogram signals of the same patient (e.g. Figure 4A, Element 56, abstract, and Column 3 lines 24-28). While there is necessarily a circuit involved for obtaining the sensed electrocardiogram. Mouchawar does not explicitly disclose a circuitry enabling the sensing unit to tolerate a post-potential of a stimulation pulse delivered by the combined defibrillation and sensing electrode.
Weerakoon et al teaches that it is known to use a circuitry enabling the sensing unit to tolerate a post-potential of a stimulation pulse delivered by the electrode as set forth in Figure 7 and Paragraphs [0066], [0087] and [0101] to provide improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mouchawar, with a circuitry enabling the sensing unit to tolerate a post-potential of a stimulation pulse delivered by the electrode as taught by Weerakoon et al, since such a modification would provide the predictable results of improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier.
Referring to Claim 2, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, wherein the combined defibrillation and sensing electrode comprises only a single electrode pole that serves for delivering stimulation pulses to a patient in need thereof and for sensing electrocardiogram signals of the same patient (e.g. Figure 4A, Element 56, abstract, and Column 3 lines 24-28).
Referring to Claim 3, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, wherein the electrode pole of the combined defibrillation and sensing electrode is designed as shock coil (e.g. Figure 4A, Element 56, abstract, and Column 3 lines 24-28).
Referring to Claim 4, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, wherein the electrode pole of the combined defibrillation and sensing electrode is designed isodiametric to an electrode lead body of the combined defibrillation and sensing electrode (e.g. Figure 4A, Element 56, abstract, and Column 3 lines 24-28).
Referring to Claim 5, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, except wherein the circuitry provides the sensing unit with a dynamic range that allows the sensing unit to tolerate a post-potential of a stimulation pulse delivered by the combined defibrillation and sensing electrode.
Weerakoon et al teaches that it is known to use the circuitry providing the sensing unit with a dynamic range that allows the sensing unit to tolerate a post-potential of a stimulation pulse delivered by the electrode as set forth in Figure 7 and Paragraphs [0066], [0087] and [0101] to provide improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mouchawar, with the circuitry providing the sensing unit with a dynamic range that allows the sensing unit to tolerate a post-potential of a stimulation pulse delivered by the electrode as taught by Weerakoon et al, since such a modification would provide the predictable results of improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier.
Referring to Claim 6, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, except wherein the circuitry is designed and arranged to perform a high-pass filtering of signals received by the combined defibrillation and sensing electrode.
Weerakoon et al teaches that it is known to use the circuitry is designed and arranged to perform a high-pass filtering of signals received by the sensing electrode as set forth in Paragraphs [0066] and [0101] and Figure 7, Element 216 to provide improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mouchawar, with the circuitry is designed and arranged to perform a high-pass filtering of signals received by the sensing electrode as taught by Weerakoon et al, since such a modification would provide the predictable results of improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier.
Referring to Claim 7, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, except wherein the circuitry serves for a DC offset compensation of signals received by the combined defibrillation and sensing electrode prior to processing the signals by the sensing unit. Weerakoon et al teaches that it is known to use the circuitry serves for a DC offset compensation of signals received by the sensing electrode prior to processing the signals by the sensing unit as set forth in Figure 9 and Paragraphs [0087] and [0101] to provide improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mouchawar, with the circuitry serves for a DC offset compensation of signals received by the sensing electrode prior to processing the signals by the sensing unit as taught by Weerakoon et al, since such a modification would provide the predictable results of improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier.
Referring to Claim 8, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, wherein an electrode lead of the combined defibrillation and sensing electrode is connected with the stimulation unit and/or with the sensing unit with a unipolar connector (e.g. Column 6 lines 59-60).
Referring to Claim 12, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, wherein the combined defibrillation and sensing electrode is a non-transvenous, in particular a subcutaneously, a submuscularly and/or a substernally implantable electrode (e.g. Figure 4A).
Referring to Claim 13, Mouchawar in view of Weerakoon et al teaches method for operating an implantable cardioverter-defibrillator according to claim 1, the method comprising the following steps: a) receiving, with the electrode pole of the combined defibrillation and sensing electrode, electrocardiogram signals of a patient carrying the implantable cardioverter-defibrillator in an implanted state (e.g. Figure 4A, Element 56, abstract, and Column 3 lines 24-28). While there is necessarily a circuit involved for processing the received electrocardiogram signal. Mouchawar does not explicitly disclose preprocessing the received electrocardiogram signals with the circuitry of the sensing unit of the implantable cardioverter-defibrillator, thus enabling the sensing unit to tolerate a post-potential of a stimulation pulse previously delivered by the combined defibrillation and sensing electrode; processing the preprocessed signals by the sensing unit.
Weerakoon et al teaches that it is known to use preprocessing the received signals with the circuitry of the sensing unit, thus enabling the sensing unit to tolerate a post-potential of a stimulation pulse previously delivered; processing the preprocessed signals by the sensing unit as set forth in Figure 7 and Paragraphs [0066], [0087] and [0101] to provide improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Mouchawar, with preprocessing the received signals with the circuitry of the sensing unit, thus enabling the sensing unit to tolerate a post-potential of a stimulation pulse previously delivered; processing the preprocessed signals by the sensing unit as taught by Weerakoon et al, since such a modification would provide the predictable results of improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier.
Referring to Claim 14, Mouchawar in view of Weerakoon et al teaches method according to claim 13, except wherein preprocessing the received electrocardiogram signals comprises subjecting the received electrocardiogram signals to a high-pass filter. Weerakoon et al teaches that it is known to use the preprocessing the received electrocardiogram signals comprises subjecting the received electrocardiogram signals to a high-pass filter as set forth in Paragraphs [0066] and [0101] and Figure 7, Element 216 to provide improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Mouchawar, with the preprocessing the received electrocardiogram signals comprises subjecting the received electrocardiogram signals to a high-pass filter as taught by Weerakoon et al, since such a modification would provide the predictable results of improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier.
Referring to Claim 15, Mouchawar in view of Weerakoon et al teaches method according to claim 13, except wherein preprocessing the received electrocardiogram signals comprises applying a DC offset compensation. Weerakoon et al teaches that it is known to use the wherein the preprocessing the received electrocardiogram signals comprises applying a DC offset compensation as set forth in Figure 9 and Paragraphs [0087] and [0101] to provide improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Mouchawar, with the wherein preprocessing the received electrocardiogram signals comprises applying a DC offset compensation as taught by Weerakoon et al, since such a modification would provide the predictable results of improved sensing of tissue voltages reliably across these different conditions without losing small signals or overloading the amplifier.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mouchawar (US Patent 6,535,762) in view of Weerakoon et al (US Publication 2023/0173273) as applied above, and further in view of Doerr (US Publication 2013/0190631).
Referring to Claim 9, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, except wherein the implantable cardioverter-defibrillator comprises a communication unit by which the implantable cardioverter-defibrillator can be connected with a home monitoring system in a wireless manner. Doerr teaches that it is known to use an implantable cardioverter-defibrillator comprises a communication unit as set forth in e.g. Figure 2, Element 84, Figure 3, and Paragraph [0049] to provide improved patient care by transmitting stored data to allow for further evaluation. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mouchawar, with an implantable cardioverter-defibrillator comprises a communication unit as taught by Doerr, since such a modification would provide the predictable results of improved patient care by transmitting stored data to allow for further evaluation.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mouchawar (US Patent 6,535,762) in view of Weerakoon et al (US Publication 2023/0173273) as applied above, and further in view of Slopsema et al (US Publication 2023/0141622).
Referring to Claim 10, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, except wherein the housing has a volume of not more than 70 cm3, in particular not more than 60 cm3.
Slopsema et al teaches that it is known to use a stimulation device with a total volume of 1.5cubic centimeters as set forth in Paragraph [0048] and claims 16 and 19 to provide reducing size of the device which reduces scarring and minimizes surgical trauma and recovery time. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mouchawar, with the housing has a volume of not more than 70 cm3, in particular not more than 60 cm3as taught by Slopsema et al, since such a modification would provide the predictable results of reducing size of the device which reduces scarring and minimizes surgical trauma and recovery time. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have a housing has a volume of not more than 70 cm3, in particular not more than 60 cm3, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), see MPEP 2144.04(IV)(A) which results reducing size of the device which reduces scarring and minimizes surgical trauma and recovery time.
Referring to Claim 11, Mouchawar in view of Weerakoon et al teaches implantable cardioverter-defibrillator according to claim 1, except wherein a header of the housing has a volume of not more than 6 cm3, in particular not more than 5 cm3.
Slopsema et al teaches that it is known to use a stimulation device with a total volume of 1.5 cubic centimeters as set forth in Paragraph [0048] and claims 16 and 19 to provide reducing size of the device which reduces scarring and minimizes surgical trauma and recovery time. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Mouchawar, with a header of the housing has a volume of not more than 6 cm3, in particular not more than 5 cm3 as taught by Slopsema et al, since such a modification would provide the predictable results of reducing size of the device which reduces scarring and minimizes surgical trauma and recovery time.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have a header of the housing has a volume of not more than 6 cm3, in particular not more than 5 cm3, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), see MPEP 2144.04(IV)(A) which results reducing size of the device which reduces scarring and minimizes surgical trauma and recovery time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zhang et al (US Publication 2005/0288719) discloses an ICD with a single electrode for sensing and pacing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/William J Levicky/Primary Examiner, Art Unit 3796
