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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of invention I (claims 1-10) in the reply filed on 08/14/2026 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/14/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: Applicant should clarify if the set of time that elapsed is from the releasing of one or more drugs alone or from the releasing of one or more drugs alone AND discharge the stored electrical charge. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Applicant should clarify how the phrase “the one or more sensors comprise…a device for detecting blood flow” would allow the device to be a sensor. Appropriate correction is required.
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 1-10 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.
Regarding claim 1, the phrase “wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient” is ambiguous because 1) is the analysis/determination calculated while treatment is occurring or is the “while treating the patient” referring to “the amount of drug released while the treating of the patient occurs”, meaning no treatment is occurring when making the analysis/determination, but rather determining what is the amount needed for when treating the patient were to occur, 2) what type of treatment is the claim referring to, and 3) how it would be possible to determine amount of drugs while treating the patient while later in the claim requires an elapsed amount of time between drug release and pacing therapy. This is contradictory with the rest of the claim language because it is unclear how and what type of “treating” is going on during the determination when later in the claim, the release of the drugs and the start of the therapy occur in response to the determination.
Regarding claim 1, it is unclear if the “amount of the one or more drugs” of line 27 is the same or different than the “amount of the one or more drugs” of line 13-14.
Claims 2-10 are rejected for being dependent on rejected independent claim 1.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Piha et al. (US 20140207201)(Hereinafter Piha).
Regarding claim 1, Piha teaches A wearable cardioverter defibrillator (WCD) system (Abstract “a wearable cardiac defibrillator system”), the WCD system comprising:
a support structure configured to be worn by a patient ([0026] “One of these components is a support structure, which is configured to be worn by the patient. The support structure can be any structure suitable for wearing, such as a harness, a vest, one or more belts, another garment, and so on.”);
an energy storage module configured to store an electrical charge ([0008] “an energy storage module configured to store a charge”);
a discharge circuit coupled to the energy storage module ([0054] “Defibrillator 200 moreover includes a discharge circuit 255. Circuit 255 can be controlled to permit the energy stored in module 250 to be discharged to nodes 214, 218, and thus also to defibrillation electrodes 204, 208.”);
a first reservoir containing one or more drugs ([0045] “Fluid deploying mechanism 274 can be configured to cause at least some of the fluid to be released from the reservoir, and be deployed near one or both of the patient locations to which the electrodes are configured to be attached.” [0044] “The fluid is preferably conductive, such as by including an electrolyte”);
one or more sensors configured to collect patient parameter signals while the patient is wearing the support structure ([0037] “Examples of such parameters include the patient's ECG, blood oxygen level, blood flow, blood pressure, blood perfusion, pulsatile change in light transmission or reflection properties of perfused tissue, heart sounds, heart wall motion, breathing sounds and pulse.” [0046] “Plus, impedance between electrodes 204, 208 and/or the connections of ECG port 219 can be sensed. Sensing the impedance can be useful for detecting, among other things, whether these electrodes 204, 208 and/or ECG electrodes 209 are not making good electrical contact with the patient's skin.”); and
a processor ([0048] “Processor 230”) configured to:
receive patient data corresponding to a patient condition from the one or more sensors ([0037] “Examples of such parameters include the patient's ECG, blood oxygen level, blood flow, blood pressure, blood perfusion, pulsatile change in light transmission or reflection properties of perfused tissue, heart sounds, heart wall motion, breathing sounds and pulse.” [0046] “Plus, impedance between electrodes 204, 208 and/or the connections of ECG port 219 can be sensed. Sensing the impedance can be useful for detecting, among other things, whether these electrodes 204, 208 and/or ECG electrodes 209 are not making good electrical contact with the patient's skin.”);
perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient ([0048] “Ventricular fibrillation is sometimes abbreviated as "VF". The patient's sensed ECG from measurement circuit 220 can be used by the VF detector to determine whether the patient is experiencing VF [combined analysis]. Detecting VF is useful, because VF often results in SCA.” [0049] “an advice module 234, which generates advice for what to do. The advice can be based on outputs of detection module 232. There can be many types of advice according to embodiments. As one example, a Shock Advisory Algorithm [combined analysis] can render the advice to shock the patient by delivering a charge, as opposed to not shock the patient. Shocking can be for defibrillation, pacing, and so on.” [0121] “if the second electrical therapy is pacing, second fluid 1265 can be an electrolyte with much less salt than 0.9% NaCl [much less amount of drugs for pacing], creating an electrode with a relatively higher impedance.” [0120] “defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) [higher amount of drugs for defib] to provide a low impedance.” The amount of drugs is based on the therapy that is chosen, from the combined analysis.);
determine, based on the combined analysis, a type of therapy advised to treat the patient, wherein the type of therapy comprises a defibrillation therapy and a pacing therapy ([0116] “make a determination as to whether the patient needs one of a first electrical therapy and a second electrical therapy, such as defibrillation or pacing as described above.” [0049] “an advice module 234, which generates advice for what to do. The advice can be based on outputs of detection module 232. There can be many types of advice according to embodiments. As one example, a Shock Advisory Algorithm can render the advice to shock the patient by delivering a charge, as opposed to not shock the patient. Shocking can be for defibrillation, pacing, and so on.”);
in response to a determination, based on a result of the combined analysis, that the pacing therapy is advised for the patient ([0121] “if the determination is that the second electrical therapy is needed. For example, if the second electrical therapy is pacing, second fluid 1265 can be an electrolyte with much less salt than 0.9% NaCl, creating an electrode with a relatively higher impedance.”):
cause the first reservoir to release the one or more drugs on the patient ([0121] “if the determination is that the second electrical therapy is needed. For example, if the second electrical therapy is pacing, second fluid 1265 can be an electrolyte with much less salt than 0.9% NaCl, creating an electrode with a relatively higher impedance.”);
start the pacing therapy after a set amount of time has elapsed from the releasing of the one or more drugs and the discharge circuit to discharge the stored electrical charge to deliver the pacing therapy to the patient (Fig. 14 where drugs are released first, then charge is released after the frugs. [0133] “operation 1420, at least some of the fluid is caused to be released from the one or more reservoirs and be deployed near a certain one of the patient locations.” [0134] “operation 1430, execution waits for at least one minute before deploying any more [fluid released from the reservoir], during which time an ECG may be taken, some of the electrical charge may be delivered, and so on.” [0136] “Operation 1440 may be repeated after more pauses, and so on…Sometimes episodes are prolonged… Anti-bradycardia pacing may need to last an hour or more, before help arrives.”); and
in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient ([0120] “the determination is that the first electrical therapy is needed. For example, if the first electrical therapy is defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” Examiner notes that the defibrillation therapy is advised, which means that pacing is not advised since they are two different types of therapies.):
adjust an amount of the one or more drugs released on the patient ([0120] “first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” The adjustment is the different amount of salt content than the pacing advice.).
Regarding claim 2, Piha teaches wherein the processor is further configured to, in response to a determination that the defibrillation therapy is advised to treat the patient, adjust the amount of the one or more drugs released on the patient ([0120] “the determination is that the first electrical therapy is needed. For example, if the first electrical therapy is defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” In comparison to the pacing therapy, the amount of drugs released is much higher.).
Regarding claim 3, Piha teaches further comprising a second reservoir in which an electrolyte is contained ([0117] “FIG. 12 may also include reservoirs 1254, 1255” [0062] “The advantages of an electrolyte reservoir constructed from metalized plastic laminate include being flexible, resisting impact pressures, size (thin), and limiting moisture vapor transmission.”).
Regarding claim 10, Piha teaches wherein the one or more sensors comprise three or more of electrodes to detect electrocardiogram data, a perfusion sensor, a pulse oximeter, a device for detecting blood flow, a sensor for detecting blood pressure, an optical sensor, an illumination sensor, a motion sensor, a device that detects heart wall movement, a sound sensor, or an SpO2 sensor ([0037] “Examples of such parameters include the patient's ECG, blood oxygen level, blood flow, blood pressure, blood perfusion, pulsatile change in light transmission or reflection properties of perfused tissue, heart sounds, heart wall motion, breathing sounds and pulse.” [0046] “Plus, impedance between electrodes 204, 208 and/or the connections of ECG port 219 can be sensed. Sensing the impedance can be useful for detecting, among other things, whether these electrodes 204, 208 and/or ECG electrodes 209 are not making good electrical contact with the patient's skin.” [0037] “the monitoring device could include a perfusion sensor, a pulse oximeter, a Doppler device for detecting blood flow, a cuff for detecting blood pressure, an optical sensor, illumination detectors and maybe sources for detecting color change in tissue, a motion sensor, a device that can detect heart wall movement, a sound sensor, a device with a microphone, an SpO2 sensor, and so on.”).
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.
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piha et al. (US 20140207201)(Hereinafter Piha) in view of Jones et al. (US 20070150008)(Hereinafter Jones).
Regarding claim 4, Piha teaches wherein the processor is further configured to:
in response to a determination that the defibrillation therapy is advised to treat the patient ([0120] “the determination is that the first electrical therapy is needed. For example, if the first electrical therapy is defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.”):
cause the second reservoir to release the electrolyte and the discharge circuit to discharge the stored electrical charge to deliver the defibrillation therapy to the patient ([0120] “the determination is that the first electrical therapy is needed. For example, if the first electrical therapy is defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” NaCl is an electrolyte.).
However, Piha does not teach release the one or more drugs on the patient from the first reservoir after the defibrillation therapy is delivered. Jones, in the same field of endeavor, teaches electrode for stimulation and a drug delivery medium (Abstract), and further teaches release the one or more drugs on the patient from the first reservoir after the defibrillation therapy is delivered ([0049] “the program may provide a drug delivery step 86 in which the drug delivery electrode is powered to impart transdermal drug delivery. The base unit may be provided with a display which, after a predetermined time after defibrillation, tells the operator to turn on the drug delivery electrode.” [0031] “The types of drugs to be administered can be a variety of cardiac drugs, and virtually any pharmaceutically active agent that might be indicated for treatment of ventricular fibrillation. One example of a cardiac drug is a heart stimulant such as epinephrine… Other cardiac drugs that could be delivered using the present invention include adenosine, bretylium, atropine sulfate, and lidocaine. Lidocaine is used to suppress ventricular ectopy and to raise the threshold for ventricular fibrillation.” [0043] “As with the other electrodes, the drug delivery electrode 74 is attached to the skin of the subject for whom a defibrillation procedure is being initiated.”) to suppress ventricular ectopy ([0031]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Piha, with the release the one or more drugs on the patient from the first reservoir after the defibrillation therapy is delivered of Jones, because such a modification would allow to suppress ventricular ectopy.
Regarding claim 5, Piha teaches wherein the processor is configured to determine that the defibrillation therapy is advised to treat the patient using a first type of patient parameter analysis algorithm (PAAA), which comprises a rhythm analysis algorithm (RAA) ([0048] “Detection module 232 can include a ventricular fibrillation ("VF") detector. The patient's sensed ECG from measurement circuit 220 can be used by the VF detector to determine whether the patient is experiencing VF. Detecting VF is useful, because VF results in SCA.” [0049] “As one example, a Shock Advisory Algorithm can render the advice to shock the patient by delivering a charge, as opposed to not shock the patient. Shocking can be for defibrillation, pacing, and so on.”).
Regarding claim 6, Piha teaches wherein the processor is configured to determine that the pacing therapy is advised to treat the patient using a second type of PAAA ([0049] “As one example, a Shock Advisory Algorithm can render the advice to shock the patient by delivering a charge, as opposed to not shock the patient. Shocking can be for defibrillation, pacing, and so on.”).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piha et al. (US 20140207201)(Hereinafter Piha) in view of Ghanem et al. (US 7496408)(Hereinafter Ghanem) and Jones et al. (US 20070150008)(Hereinafter Jones).
Regarding claim 7, Piha teaches the invention of claim 1 . However, Piha does not teach one or more drugs comprise a topical pain reliever. Ghanem, in the same field of endeavor, teaches a pacemaker with pacing electrodes for delivering pacing therapy to the heart (Abstract), and further teaches wherein the one or more drugs comprise a … pain reliever (Col. 13-14 lines 66-67 and 1-2 “Delivery of analgesic drugs for pain control may be provided by dispenser 360 continuously in response to subcutaneous pacing functions being enabled.”) to reduce the pain of the pacing therapy (Col. 13 lines 45-55). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Piha, with the one or more drugs comprise a topical pain reliever of Ghanem, because such a modification would allow to reduce the pain of the pacing therapy.
However, Piha in view of and Ghanem do not teach a topical drug. Jones, in the same field of endeavor, teaches electrode for stimulation and a drug delivery medium (Abstract), and further teaches a topical drug delivery ([0031] “The types of drugs to be administered can be a variety of cardiac drugs, and virtually any pharmaceutically active agent that might be indicated for treatment of ventricular fibrillation. One example of a cardiac drug is a heart stimulant such as epinephrine… Other cardiac drugs that could be delivered using the present invention include adenosine, bretylium, atropine sulfate, and lidocaine. Lidocaine is used to suppress ventricular ectopy and to raise the threshold for ventricular fibrillation.” [0043] “As with the other electrodes, the drug delivery electrode 74 is attached to the skin of the subject for whom a defibrillation procedure is being initiated.”) to suppress ventricular ectopy ([0031]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Piha in view of Ghanem, with the topical drug delivery of Jones, because such a modification would allow to suppress ventricular ectopy.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piha et al. (US 20140207201)(Hereinafter Piha) in view of Volpe et al. (US 20160253471)(Hereinafter Volpe).
Regarding claim 8, Piha teaches the invention of claim 1 . However, Piha does not teach processor is further configured to determine if the pacing therapy is advised to treat a complete heart block condition based on the result of the combined analysis. Volpe, in the dame field of endeavor, teaches wherein the processor is further configured to determine if the pacing therapy is advised to treat a complete heart block condition based on the result of the combined analysis ([0106] “a pacing device can be used to deliver a pacing pulse to a patient, for example, as intervention for symptomatic bradycardias or a complete heart block.) to treat complete heart block would merely yield predictable results. Further, to replace the pacing therapy with drug therapy would not yield any unpredictable results since drugs are known to treat bradycardia. See KSR, 550 U.S. at 416-417.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piha et al. (US 20140207201)(Hereinafter Piha) in view of Subramanian et al. (US 20150217121)(Hereinafter Subramanian).
Regarding claim 9, Piha teaches the invention of claim 1 . However, Piha does not teach processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval. Subramanian, in the same field of endeavor, teaches a wearable defibrillator for determining arrhythmias and delivering shock (Abstract), and further teaches wherein the processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval ([0100] “This type of heart monitor could transmit information wirelessly to the wearable defibrillator's self-contained computer which could analyze the signal/information and determine whether defibrillation therapy is required. If so, an alert can occur in the wearable defibrillator itself, or through the patient interface in the form of either and visual signal, audio signal, or vibration. The wearer of the defibrillator will have the opportunity to abort the delivery of therapy by touching the wrist worn patient interface.”) to allow the user to be aware of imminent shock ([0100]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Piha, with the processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval of Subramanian, because such a modification would allow to allow the user to be aware of imminent shock.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-7 of U.S. Patent No. US 12121736 (Hereinafter ‘736) in view of Piha et al. (US 20140207201)(Hereinafter Piha).
Regarding claim 1, ‘736 teaches A wearable cardioverter defibrillator (WCD) system (Claim 1 “A wearable cardioverter defibrillator (WCD) system”), the WCD system comprising:
a support structure configured to be worn by a patient (Claim 1 “a support structure configured to be worn by an ambulatory patient”);
an energy storage module configured to store an electrical charge (Claim 1 “energy storage module configured to store an electrical charge”);
a discharge circuit coupled to the energy storage module (Claim 1 “discharge circuit coupled to the energy storage module”);
a first reservoir containing one or more drugs (Claim 1 “a first reservoir in which an electrolyte is contained”);
one or more sensors configured to collect patient parameter signals while the patient is wearing the support structure (Claim 1 “one or more sensors configured to sense an Electrocardiogram (ECG) signal of the ambulatory patient while the ambulatory patient is wearing the support structure”); and
a processor (Claim 1 “a processor”) configured to:
receive patient data corresponding to a patient condition from the one or more sensors (Claim 1 “receive the ECG signal of the ambulatory patient from the one or more sensors, perform a first rhythm analysis on the received ECG signal of the ambulatory patient”);
determine, based on the combined analysis, a type of therapy advised to treat the patient, wherein the type of therapy comprises a defibrillation therapy and a pacing therapy (Claim 1 “determine whether a shock is advised for the ambulatory patient based on a result of the first rhythm analysis performed on the received ECG signal, perform a second rhythm analysis, different from the first rhythm analysis, on the received ECG signal of the ambulatory patient to determine whether pacing therapy is advised for the ambulatory patient”);
in response to a determination, based on a result of the combined analysis, that the pacing therapy is advised for the patient (Claim 1 “in response to a determination that the pacing therapy is advised for the ambulatory patient based on a result of the second rhythm analysis and the shock is not advised based on the result of the first rhythm analysis”):
cause the first reservoir to release the one or more drugs on the patient (Claim 1 “cause the second reservoir to release the one or more drugs on the ambulatory patient, the one or more drugs comprising a topical sedative, the first reservoir to release the electrolyte on the ambulatory patient”);
start the pacing therapy after a set amount of time has elapsed from the releasing of the one or more drugs and the discharge circuit to discharge the stored electrical charge to deliver the pacing therapy to the patient (Claim 1 “delay the pacing therapy after a set amount of time has elapsed from the releasing of the one or more drugs and the discharge circuit to discharge the stored electrical charge to deliver the pacing therapy to the ambulatory patient”); and
in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient (Claim 1 “in response to a determination that the shock is advised for the ambulatory patient based on the result of the first rhythm analysis”):
However, ‘376 does not teach perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient and in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient and adjust an amount of the one or more drugs released on the patient. Piha, in the same field of endeavor, teaches a wearable pacing and defibrillation system that delivers drugs to a user (Abstract), and further teaches perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient ([0048] “Ventricular fibrillation is sometimes abbreviated as "VF". The patient's sensed ECG from measurement circuit 220 can be used by the VF detector to determine whether the patient is experiencing VF [combined analysis]. Detecting VF is useful, because VF often results in SCA.” [0049] “an advice module 234, which generates advice for what to do. The advice can be based on outputs of detection module 232. There can be many types of advice according to embodiments. As one example, a Shock Advisory Algorithm [combined analysis] can render the advice to shock the patient by delivering a charge, as opposed to not shock the patient. Shocking can be for defibrillation, pacing, and so on.” [0121] “if the second electrical therapy is pacing, second fluid 1265 can be an electrolyte with much less salt than 0.9% NaCl [much less amount of drugs for pacing], creating an electrode with a relatively higher impedance.” [0120] “defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) [higher amount of drugs for defib] to provide a low impedance.”);
in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient ([0120] “the determination is that the first electrical therapy is needed. For example, if the first electrical therapy is defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” Examiner notes that the defibrillation therapy is advised, which means that pacing is not advised since they are two different types of shocks.):
adjust an amount of the one or more drugs released on the patient ([0120] “first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” The adjustment is the different amount of salt content than the pacing advice.) to optimize the therapy to a user’s condition ([0114]-[0116]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of ‘376, with the perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient and in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient and adjust an amount of the one or more drugs released on the patient of Piha, because such a modification would allow to optimize the therapy to a user’s condition.
Regarding claim 2, claim 1 is obvious over ‘736 and Piha. However, ‘736 does not teach perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient and in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient and adjust an amount of the one or more drugs released on the patient. Piha, in the same field of endeavor, teaches a wearable pacing and defibrillation system that delivers drugs to a user (Abstract), and further teaches wherein the processor is further configured to, in response to a determination that the defibrillation therapy is advised to treat the patient, adjust the amount of the one or more drugs released on the patient ([0120] “the determination is that the first electrical therapy is needed. For example, if the first electrical therapy is defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” In comparison to the pacing therapy, the amount of drugs released is much higher.) to optimize the therapy to a user’s condition ([0114]-[0116]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of ‘736, with the perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient and in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient and adjust an amount of the one or more drugs released on the patient of Piha, because such a modification would allow to optimize the therapy to a user’s condition.
Regarding claim 3, ‘736 teaches further comprising a second reservoir in which an electrolyte is contained (Claim 1 “cause the first reservoir to release the electrolyte”).
Regarding claim 4, ‘736 teaches wherein the processor is further configured to:
in response to a determination that the defibrillation therapy is advised to treat the patient (Claims 1 “and in response to a determination that the shock is advised for the ambulatory patient based on the result of the first rhythm analysis”):
cause the second reservoir to release the electrolyte and the discharge circuit to discharge the stored electrical charge to deliver the defibrillation therapy to the patient (Claim 1 “cause the first reservoir to release the electrolyte and the discharge circuit to discharge the stored electrical charge to deliver the shock to the ambulatory patient” NaCl is an electrolyte.);
release the one or more drugs on the patient from the first reservoir after the defibrillation therapy is delivered (Claim 1 “release the one or more drugs on the ambulatory patient from the second reservoir after the shock is administered, wherein the one or more drugs comprise a topical pain reliever”).
Regarding claim 5, ‘736 teaches wherein the processor is configured to determine that the defibrillation therapy is advised to treat the patient using a first type of patient parameter analysis algorithm (PAAA), which comprises a rhythm analysis algorithm (RAA) (Claim 1 “determine whether a shock is advised for the ambulatory patient based on a result of the first rhythm analysis performed on the received ECG signal,”).
Regarding claim 6, ‘736 teaches wherein the processor is configured to determine that the pacing therapy is advised to treat the patient using a second type of PAAA (Claim 1 “perform a second rhythm analysis, different from the first rhythm analysis, on the received ECG signal of the ambulatory patient to determine whether pacing therapy is advised for the ambulatory patient”).
Regarding claim 7, ‘736 teaches wherein the one or more drugs comprise a topical pain reliever (Claims 5 and 6 “wherein the one or more drugs include Propofol. wherein the one or more drugs include lidocaine.”).
Regarding claim 8, ‘736 teaches wherein the processor is further configured to determine if the pacing therapy is advised to treat a complete heart block condition based on the result of the combined analysis (Claim 7 “the processor is further configured to determine if the pacing therapy is advised to treat a complete heart block condition based on the result of the second rhythm analysis.”).
Regarding claim 10, ‘736 teaches wherein the one or more sensors comprise three or more of electrodes to detect electrocardiogram data, a perfusion sensor, a pulse oximeter, a device for detecting blood flow, a sensor for detecting blood pressure, an optical sensor, an illumination sensor, a motion sensor, a device that detects heart wall movement, a sound sensor, or an SpO2 sensor (Claim 1 “one or more sensors configured to sense an Electrocardiogram (ECG) signal”).
Claim 9 rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. US 12121736 (Hereinafter ‘736) in view of Piha et al. (US 20140207201)(Hereinafter Piha) and Subramanian et al. (US 20150217121)(Hereinafter Subramanian).
Regarding claim 9, claim 1 is obvious over ‘376 and Piha. However, ‘376 in view of Piha do not teach processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval. Subramanian, in the same field of endeavor, teaches a wearable defibrillator for determining arrhythmias and delivering shock (Abstract), and further teaches wherein the processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval ([0100] “This type of heart monitor could transmit information wirelessly to the wearable defibrillator's self-contained computer which could analyze the signal/information and determine whether defibrillation therapy is required. If so, an alert can occur in the wearable defibrillator itself, or through the patient interface in the form of either and visual signal, audio signal, or vibration. The wearer of the defibrillator will have the opportunity to abort the delivery of therapy by touching the wrist worn patient interface.”) to allow the user to be aware of imminent shock ([0100]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of ‘376 in view of Piha, with the processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval of Subramanian, because such a modification would allow to allow the user to be aware of imminent shock.
Claims 1-3, 7-8 and 10 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. US 10967193 (Hereinafter ‘193) in view of Piha et al. (US 20140207201)(Hereinafter Piha).
Regarding claim 1, ‘193 teaches A wearable cardioverter defibrillator (WCD) system (Claim 1 “A wearable cardioverter defibrillator (WCD) system”), the WCD system comprising:
a support structure configured to be worn by a patient (Claim 1 “a support structure configured to be worn by an ambulatory patient”);
an energy storage module configured to store an electrical charge (Claim 1 “energy storage module configured to store an electrical charge”);
a discharge circuit coupled to the energy storage module (Claim 1 “discharge circuit coupled to the energy storage module”);
a first reservoir containing one or more drugs (Claim 1 “a first reservoir in which an electrolyte is contained”);
one or more sensors configured to collect patient parameter signals while the patient is wearing the support structure (Claim 1 “sensors configured to sense an Electrocardiogram (ECG) signal of the ambulatory patient while the ambulatory patient is wearing the support structure”); and
a processor (Claim 1 “a processor”) configured to:
receive patient data corresponding to a patient condition from the one or more sensors (Claim 1 “receive the ECG signal”);
determine, based on the combined analysis, a type of therapy advised to treat the patient, wherein the type of therapy comprises a defibrillation therapy and a pacing therapy (Claim 1 “determine from the RAA whether a shock is advised or pacing therapy is advised for the patient”);
in response to a determination, based on a result of the combined analysis, that the pacing therapy is advised for the patient (Claim 1 “prepare to deliver pacing therapy in response to a determination that the pacing therapy is advised for the patient and the shock is not advised”):
cause the first reservoir to release the one or more drugs on the patient (Claim 1 “wherein the second reservoir topically releases the one or more drugs on the patient, the one or more drugs comprising a topical pain reliever and/or a topical sedative, the first reservoir releases the electrolyte after a set amount of time after the one or more drugs are released on the patient to penetrate into the patient's skin”);
start the pacing therapy after a set amount of time has elapsed from the releasing of the one or more drugs and the discharge circuit to discharge the stored electrical charge to deliver the pacing therapy to the patient (Claim 1 “wherein the second reservoir topically releases the one or more drugs on the patient, the one or more drugs comprising a topical pain reliever and/or a topical sedative, the first reservoir releases the electrolyte after a set amount of time after the one or more drugs are released on the patient to penetrate into the patient's skin the discharge circuit discharges the stored electrical charge to deliver pacing therapy to the patient”); and
in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient (Claim 1 “prepare to administer a shock in response to a determination that the shock is advised for the patient”):
However, ‘193 does not teach perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient and in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient and adjust an amount of the one or more drugs released on the patient. Piha, in the same field of endeavor, teaches a wearable pacing and defibrillation system that delivers drugs to a user (Abstract), and further teaches perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient ([0048] “Ventricular fibrillation is sometimes abbreviated as "VF". The patient's sensed ECG from measurement circuit 220 can be used by the VF detector to determine whether the patient is experiencing VF [combined analysis]. Detecting VF is useful, because VF often results in SCA.” [0049] “an advice module 234, which generates advice for what to do. The advice can be based on outputs of detection module 232. There can be many types of advice according to embodiments. As one example, a Shock Advisory Algorithm [combined analysis] can render the advice to shock the patient by delivering a charge, as opposed to not shock the patient. Shocking can be for defibrillation, pacing, and so on.” [0121] “if the second electrical therapy is pacing, second fluid 1265 can be an electrolyte with much less salt than 0.9% NaCl [much less amount of drugs for pacing], creating an electrode with a relatively higher impedance.” [0120] “defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) [higher amount of drugs for defib] to provide a low impedance.”);
in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient ([0120] “the determination is that the first electrical therapy is needed. For example, if the first electrical therapy is defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” Examiner notes that the defibrillation therapy is advised, which means that pacing is not advised since they are two different types of shocks.):
adjust an amount of the one or more drugs released on the patient ([0120] “first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” The adjustment is the different amount of salt content than the pacing advice.) to optimize the therapy to a user’s condition ([0114]-[0116]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of ‘193, with the perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient and in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient and adjust an amount of the one or more drugs released on the patient of Piha, because such a modification would allow to optimize the therapy to a user’s condition.
Regarding claim 2, claim 1 is obvious over ‘193 and Piha. However, ‘193 does not teach perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient and in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient and adjust an amount of the one or more drugs released on the patient. Piha, in the same field of endeavor, teaches a wearable pacing and defibrillation system that delivers drugs to a user (Abstract), and further teaches wherein the processor is further configured to, in response to a determination that the defibrillation therapy is advised to treat the patient, adjust the amount of the one or more drugs released on the patient ([0120] “the determination is that the first electrical therapy is needed. For example, if the first electrical therapy is defibrillation, first fluid 1264 can be a saline solution with a relatively high salt content (e.g. 0.9% NaCl) to provide a low impedance.” In comparison to the pacing therapy, the amount of drugs released is much higher.) to optimize the therapy to a user’s condition ([0114]-[0116]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of ‘193, with the perform a combined analysis of the patient data to analyze the patient condition, wherein the combined analysis determines an amount of the one or more drugs to be released while treating the patient and in response to a determination, based on a result of the combined analysis, that the pacing therapy is not advised for the patient and adjust an amount of the one or more drugs released on the patient of Piha, because such a modification would allow to optimize the therapy to a user’s condition.
Regarding claim 3, ‘193 teaches further comprising a second reservoir in which an electrolyte is contained (Claim 1 “a first reservoir in which an electrolyte is contained”).
Regarding claim 7, ‘193 teaches wherein the one or more drugs comprise a topical pain reliever (Claim 1 “the one or more drugs comprising a topical pain reliever and/or a topical sedative”).
Regarding claim 8, ‘736 teaches wherein the processor is further configured to determine if the pacing therapy is advised to treat a complete heart block condition based on the result of the combined analysis (Claim 7 “wherein the processor is further configured to determine if the pacing therapy is advised to treat a complete heart block condition.”).
Regarding claim 10, ‘193 teaches wherein the one or more sensors comprise three or more of electrodes to detect electrocardiogram data, a perfusion sensor, a pulse oximeter, a device for detecting blood flow, a sensor for detecting blood pressure, an optical sensor, an illumination sensor, a motion sensor, a device that detects heart wall movement, a sound sensor, or an SpO2 sensor (Claim 1 “sensors configured to sense an Electrocardiogram (ECG) signal of the ambulatory patient while the ambulatory patient is wearing the support structure”).
Claims 4-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18 U.S. Patent No. US 12121736 (Hereinafter ‘736) in view of Piha et al. (US 20140207201)(Hereinafter Piha) and Jones et al. (US 20070150008)(Hereinafter Jones).
Regarding claim 4, ‘736 teaches wherein the processor is further configured to:
in response to a determination that the defibrillation therapy is advised to treat the patient (Claims 1 “prepare to administer a shock in response to a determination that the shock is advised for the patient”):
cause the second reservoir to release the electrolyte and the discharge circuit to discharge the stored electrical charge to deliver the defibrillation therapy to the patient (Claim 1 “wherein the first reservoir releases the electrolyte and the discharge circuit discharges the stored electrical charge to deliver a shock to the patient.”);
However, Piha does not teach release the one or more drugs on the patient from the first reservoir after the defibrillation therapy is delivered. Jones, in the same field of endeavor, teaches electrode for stimulation and a drug delivery medium (Abstract), and further teaches release the one or more drugs on the patient from the first reservoir after the defibrillation therapy is delivered ([0049] “the program may provide a drug delivery step 86 in which the drug delivery electrode is powered to impart transdermal drug delivery. The base unit may be provided with a display which, after a predetermined time after defibrillation, tells the operator to turn on the drug delivery electrode.” [0031] “The types of drugs to be administered can be a variety of cardiac drugs, and virtually any pharmaceutically active agent that might be indicated for treatment of ventricular fibrillation. One example of a cardiac drug is a heart stimulant such as epinephrine… Other cardiac drugs that could be delivered using the present invention include adenosine, bretylium, atropine sulfate, and lidocaine. Lidocaine is used to suppress ventricular ectopy and to raise the threshold for ventricular fibrillation.” [0043] “As with the other electrodes, the drug delivery electrode 74 is attached to the skin of the subject for whom a defibrillation procedure is being initiated.”) to suppress ventricular ectopy ([0031]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of Piha, with the release the one or more drugs on the patient from the first reservoir after the defibrillation therapy is delivered of Jones, because such a modification would allow to suppress ventricular ectopy.
Regarding claim 5, ‘736 teaches wherein the processor is configured to determine that the defibrillation therapy is advised to treat the patient using a first type of patient parameter analysis algorithm (PAAA), which comprises a rhythm analysis algorithm (RAA) (Claim 1 “determine from the RAA whether a shock is advised or pacing therapy is advised for the patient”).
Regarding claim 6, ‘736 teaches wherein the processor is configured to determine that the pacing therapy is advised to treat the patient using a second type of PAAA (Claim 18 “perform a first patient parameter analysis algorithm (PPAA) on the received patient parameter signal, determine from the first PPAA whether a shock is advised for the patient”).
Claim 9 rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. US 12121736 (Hereinafter ‘736) in view of Piha et al. (US 20140207201)(Hereinafter Piha) and Subramanian et al. (US 20150217121)(Hereinafter Subramanian).
Regarding claim 9, claim 1 is obvious over ‘376 and Piha. However, ‘376 in view of Piha do not teach processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval. Subramanian, in the same field of endeavor, teaches a wearable defibrillator for determining arrhythmias and delivering shock (Abstract), and further teaches wherein the processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval ([0100] “This type of heart monitor could transmit information wirelessly to the wearable defibrillator's self-contained computer which could analyze the signal/information and determine whether defibrillation therapy is required. If so, an alert can occur in the wearable defibrillator itself, or through the patient interface in the form of either and visual signal, audio signal, or vibration. The wearer of the defibrillator will have the opportunity to abort the delivery of therapy by touching the wrist worn patient interface.”) to allow the user to be aware of imminent shock ([0100]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the system of ‘376 in view of Piha, with the processor is further configured to issue alerts to the patient warning about an upcoming delivery of the pacing therapy, and wherein the pacing therapy is to be delivered after a pre-defined time interval of Subramanian, because such a modification would allow to allow the user to be aware of imminent shock.
Conclusion
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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