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 .
Response to Amendments
The Amendment filed 6/9/2026 has been entered. Claims 1-9 and 11-18 were amended. Thus, claims 1-18 are pending in the application.
Claim Objections
Claims 2-4 and 18 are objected to because of the following informalities: claims 2-4 and 18 recite “comprises the steps of:” in line 1, and are suggested to read --comprising:-- in order to avoid antecedent basis issues. 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 3-4, 6-9, 15, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 3, the limitation “administering acoustic shock waves or pressure pulses” in line 9 is confusing, as it is unclear whether this limitation is meant to be the same as “administering acoustic shock waves or pressure pulses” of claim 1.
Regarding claim 6, the limitation “administration of the acoustic shock waves or pressure pulses” in lines 1-2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “administering acoustic shock waves or pressure pulses” of claim 1.
Regarding claim 7, the limitation “administration of the acoustic shock waves or pressure pulses” in line 2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “administering acoustic shock waves or pressure pulses” of claim 1.
Regarding claim 8, the limitation “administration of the acoustic shock waves or pressure pulses” in line 2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “administering acoustic shock waves or pressure pulses” of claim 1.
Regarding claim 9, the limitation “administration of the acoustic shock waves or pressure pulses” in lines 1-2 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “administering acoustic shock waves or pressure pulses” of claim 1.
Claim 15 recites the limitation "the repeated administrations" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitations “the repeated administrations” in lines 1-2, “subsequent administrations” in line 3, and “earlier administrations” in line 4 are confusing, as it is unclear whether these limitations are meant to be a part of or separate from “administering ” in claim 1 and/or “administration” in claim 9.
Regarding claim 18, the limitation “the irregular heartbeat patterns” in line 3 is confusing, as it is unclear whether this is meant to be the same as or different from “irregular heart rhythm” in claim 17. Moreover, the limitation “administration of the acoustic shock waves or pressure pulses” in line 6 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “administering acoustic shock waves or pressure pulses” of claim 17.
Any remaining claims are rejected based on their dependency on a rejected base claim.
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.
Claims 1-3, 5-12, 14, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Peters et al. (WO 2023/285494 A1) in view of Schultheiss et al. (US 2006/0100550 A1), Haluska et al. (US 4,830,006), and Loeb et al. (US 2005/0075531 A1).
Regarding claim 1, Peters discloses a treatment method to reduce or eliminate a patient's symptoms of irregular heart rhythm, atrial fibrillation, or abnormal heart rhythm (wearable device for generating extracorporeal shock waves for treating heart disease, such as atrial fibrillation and ventricular tachycardia) (abstract; page 2 lines 14-16; page 29 lines 9-16), wherein the treatment method comprises:
administering acoustic shock waves or pressure pulses directed to an area at or near a heart or chest of the patient (shock wave therapy administered to a thoracic region of a user) (Figs. 4-11; page 24 lines 1-20; page 33 lines 15-18);
monitoring a heartbeat pattern of the patient during administration of the acoustic shock waves or pressure pulses (cardiac rhythm sensors can be used to observe the heartbeat at the same time as the shock wave transducer stimulates the heart) (Figs. 4-11; page 16 lines 33-34; page 17 lines 1-10; page 24 lines 1-20; page 33 lines 15-18).
Peters does not disclose such that cardiac tissue of the patient is exposed to converging, diverging, planar, or near-planar portions of the emitted acoustic shock waves or pressure pulses while positioned outside a geometric focal volume or focal point of the emitted acoustic shock waves or pressure pulses.
However, Schultheiss teaches a method of using acoustic shock waves to stimulate an organ such as the heart (Schultheiss; abstract) such that cardiac tissue of the patient is exposed to converging, diverging, planar, or near-planar portions of the emitted acoustic shock waves or pressure pulses while positioned outside a geometric focal volume or focal point of the emitted acoustic shock waves or pressure pulses (the substance, i.e. the heart, can be stimulated by acoustic shock waves that are convergent, divergent, or near planar; the emitted shock waves can have a focal point the extends beyond the target treatment site) (Schultheiss; abstract; para. [0028]; para. [0127]).
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 Peters method such that cardiac tissue of the patient is exposed to converging, diverging, planar, or near-planar portions of the emitted acoustic shock waves or pressure pulses while positioned outside a geometric focal volume or focal point of the emitted acoustic shock waves or pressure pulses, as taught by Schultheiss, for the purpose of reducing or eliminating a localized intensity zone associated with noticeable pain while providing a wide or enlarged treatment volume at a variety of depths more closely associated with high energy focused wave treatment (Schultheiss; para. [0127]).
Peters does not disclose continuing administration of the acoustic shock waves or pressure pulses until the heartbeat pattern changes from an irregular heartbeat pattern to a regular heartbeat pattern.
However, Haluska teaches a method of using a cardiac stimulator (Haluska; abstract) including continuing administration of stimulation until the heartbeat pattern changes from an irregular heartbeat pattern to a regular heartbeat pattern (stimulator detects and distinguishes between normal and abnormal tachycardias, and delivers therapies if abnormal; stimulator provides the necessary stimuli to pace the heart until normal heart activity is detected) (Haluska; col. 8 lines 35-55; col. 10 lines 30-42; claims 21, 23).
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 Peters method to include continuing administration of stimulus until the heartbeat pattern changes from an irregular heartbeat pattern to a regular heartbeat pattern, as taught by Haluska, for the purpose of ensuring a patient is not treated unless necessary (Haluska; col. 2 lines 18-41).
With this modification, the modified Peters method would thus teach continuing administration of the acoustic shock waves or pressure pulses until the heartbeat pattern changes from an irregular heartbeat pattern to a regular heartbeat pattern (the modified Peters wearable device 100 would stop administering extracorporeal shock waves when it detects the normal heartbeat pattern as taught by Haluska) (Peters, Figs. 1 and 4-11, page 16 lines 33-34, page 17 lines 1-10, page 33 lines 15-18; Haluska, col. 8 lines 35-55, col. 10 lines 30-42, claims 21, 23).
Peters does not disclose thereafter monitoring the patient for recurrence of the irregular heartbeat pattern and repeating administration of the acoustic shock waves or pressure pulses upon detection of the recurrence.
However, Loeb teaches a non-invasive procedure for circulatory assistance (Loeb; abstract) including thereafter monitoring the patient for recurrence of the irregular heartbeat pattern and repeating administration of the stimulus upon detection of the recurrence (an ECG is used to monitor a patient’s heart rhythm; when the ECG detects another abnormal heart rhythm after the first abnormal heart rhythm was treated and restored to normal, treatment is again resumed) (Loeb; para. [0113]).
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 Peters method to include thereafter monitoring the patient for recurrence of the irregular heartbeat pattern and repeating administration of the stimulus upon detection of the recurrence, as taught by Loeb, for the purpose of helping to ensure a patient’s subsequent abnormal heart rhythms are treated (Loeb; para. [0113]).
With this modification, the modified Peters would thus teach thereafter monitoring the patient for recurrence of the irregular heartbeat pattern and repeating administration of the acoustic shock waves or pressure pulses upon detection of the recurrence (the modified Peters wearable device 100 would again administer the extracorporeal shock wave treatment when it detects another abnormal heartbeat pattern as taught by Loeb) (Peters, Figs. 1 and 4-11, page 16 lines 33-34, page 17 lines 1-10, page 33 lines 15-18; Loeb, para. [0113]).
Regarding claim 2, the modified Peters teaches further comprises the steps of: activating a generator to emit the acoustic shock waves or pressure pulses (wearable device 100 for generating extracorporeal shock waves) (Peters; Figs. 1, 4-11; page 33 lines 15-18), wherein the emitted acoustic shock waves or pressure pulses are focused (high intensity focused ultrasound; generated shock wave can be controlled regarding focus) (Peters; page 9 lines 26-31; page 12 lines 23-25; page 13 lines 7-9).
Regarding claim 3, as best understood, the modified Peters teaches further comprises the steps of: coupling an electrocardiogram monitoring device to the patient having said irregular heart rhythm (cardiac rhythm detection sensor can include electrocardiography, and can be used to detect heart arrhythmias of the patient) (Peters; page 16 lines 19-26); activating the electrocardiogram monitoring device and observing a heartbeat pattern of the patient (electrocardiography is a known means of observing heartbeat patterns; the cardiac rhythm detection sensor would have to have been activated in order to function) (Peters; page 16 lines 19-26); determining whether the irregular heart rhythm pattern exists based on observing the heartbeat pattern (cardiac rhythm detection sensor can include electrocardiography, and can be used to detect heart arrhythmias of the patient) (Peters; page 16 lines 19-26); observing the heartbeat pattern on the electrocardiogram monitoring device while administering acoustic shock waves or pressure pulses directed to the area near the heart or chest of the patient (cardiac rhythm sensors can be used to observe the heartbeat at the same time as the shock wave transducer stimulates the heart) (Peters; Figs. 4-11; page 16 lines 33-34; page 17 lines 1-10; page 24 lines 1-20; page 33 lines 15-18); and stopping the administration of the acoustic shock waves or pressure pulses when the heartbeat pattern being observed changes to a regular heartbeat pattern as displayed on the electrocardiogram monitoring device (the modified Peters wearable device 100 would administering the extracorporeal shock wave treatment when it detects the abnormal heartbeat pattern is stopped as taught by Loeb) (Peters, Figs. 1 and 4-11, page 16 lines 33-34, page 17 lines 1-10, page 33 lines 15-18; Loeb, para. [0113]).
Regarding claim 5, the modified Peters teaches wherein the shock wave or pressure pulse generator is acoustically coupled to skin of the patient using a coupling gel or liquid (acoustic impedance matching liquid such as ultrasound gel couples the wearable device to the user’s skin) (Peters; page 31 lines 26-28; page 32 lines 9-13).
Regarding claim 6, as best understood, the modified Peters teaches wherein administration of the acoustic shock waves or pressure pulses to the area causes a release of nitric oxide, secretion of digestive enzymes, hormones and bodily fluids, reduction of inflammation, and absorption of plaque (Peters recites the wearable device is configured for molecular effects such as increased nitric oxide, anti-inflammatory properties, etc. Moreover, according to the Applicant’s specification para. [0010], stimulating the area with the shock wave or pressure pulse generator is the only step required for the natural and inherent release of nitric oxide, secretion of digestive enzymes, hormones, and bodily fluids, reduction of inflammation, and absorption of plaque. As Peters teaches that stimulation step, Peters would also naturally and inherently function as claimed.) (Peters; Figs. 4-11; page 24 lines 1-20; page 27 lines 26-29; page 33 lines 15-18).
Regarding claim 7, as best understood, the modified Peters teaches wherein administration of the acoustic shock waves or pressure pulses to the area causes release of growth factors (According to the Applicant’s specification para. [0010], stimulating the area with the shock wave or pressure pulse generator is the only step required for the natural and inherent release of growth factors including VEGF in the patient. As Peters teaches that stimulation step, Peters would also naturally and inherently function as claimed.) (Peters; Figs. 4-11; page 24 lines 1-20; page 27 lines 26-29; page 33 lines 15-18).
Regarding claim 8, as best understood, the modified Peters teaches wherein administration of the acoustic shock waves or pressure pulses to the area causes new blood vessels to be created increasing vascularization (Peters recites the wearable device is configured for the upregulation an angiogenic factors, which would thereby increase vascularization. Moreover, according to the Applicant’s specification para. [0010], stimulating the area with the shock wave or pressure pulse generator is the only step required for new blood vessels to be naturally and inherently created to increase vascularization in a patient. As Peters teaches that stimulation step, Peters would also naturally and inherently function as claimed.) (Peters; Figs. 4-11; page 24 lines 1-20; page 27 lines 26-29; page 33 lines 15-18).
Regarding claim 9, as best understood, the modified Peters teaches wherein administration of the acoustic shock waves or pressure pulses is performed one or more times before, during, or after a medical procedure (first time usage requires calibration of the wearable device, and there are future usages as there are next calibrations of the wearable device for use; each treatment can comprise multiple impulses to different areas, and treatments can occur multiple times a week) (Peters; page 19 lines 21-27; page 21 lines 1-9; page 25 lines 25-33).
Regarding claims 10-12, the modified Peters teaches wherein the emitted acoustic shock waves or pressure pulses are low energy soft waves; wherein the low energy soft waves have an energy density in a range of 0.01 mJ/mm2 to 1.0 mJ/mm2; wherein the low energy soft waves have an energy density in a range of 0.04 mJ/mm2 to 0.3 mJ/mm2 (shock waves with a low energy level of 0.02 mJ/mm2 or above, and mentions a higher energy level can be 0.38 mJ/mm2, thus there is a range of 0.02-0.38 mJ/mm2) (Peters; page 5 lines 33-34; page 25 lines 25-33).
Regarding claim 14, the modified Peters teaches wherein the emitted acoustic shock waves or pressure pulses are emitted from a source (high intensity focused ultrasound; generated shock wave can be controlled regarding focus; as no lens is recited in the Peters reference, there is assumed to be no lens for the shock wave transducer unit 114 which generates the shock waves) (Peters; Figs. 1, 8; page 9 lines 26-31; page 12 lines 23-25; page 13 lines 7-9; page 34 lines 5-7) that is one of electrohydraulic, electromagnetic, or piezoelectric configured to produce the acoustic shock waves or pressure pulses (shock wave transducer unit 114 includes an electrohydraulic source, a piezoelectric source, and/or an electromagnetic source) (Peters; page 42 lines 10-14) and wherein the acoustic shock waves or pressure pulses are administered noninvasively (the wearable device emits extracorporeal shockwaves, and so is non-invasive) (Peters; page 16 lines 6-10).
Regarding claim 16, the modified Peters teaches wherein the emitted acoustic shock waves or pressure pulses have an energy density in a range of 0.01 mJ/mm2 to 50 mJ/mm2 (shock waves with a low energy level of 0.02 mJ/mm2 or above, and mentions a higher energy level can be 0.38 mJ/mm2, thus there is a range of 0.02-0.38 mJ/mm2) (page 5 lines 33-34; page 25 lines 25-33).
Regarding claim 17, Peters discloses a treatment method to reduce or eliminate a patient's irregular heart rhythm (wearable device for generating extracorporeal shock waves for treating heart disease, such as atrial fibrillation and ventricular tachycardia) (abstract; page 2 lines 14-16; page 29 lines 9-16), comprising: coupling an electrocardiogram monitoring device to a heart or chest of the patient having said irregular heart rhythm (cardiac rhythm detection sensor can include electrocardiography, and can be used to detect heart arrhythmias of the patient) (page 16 lines 19-26); activating the electrocardiogram monitoring device and observing a heartbeat pattern of the patient (cardiac rhythm detection sensor can include electrocardiography; electrocardiography is a known means of observing heartbeat patterns; the cardiac rhythm detection sensor would have to have been activated in order to function) (page 16 lines 19-26); deterring whether the irregular heart rhythm exists based on observing the heartbeat pattern (cardiac rhythm detection sensor can include electrocardiography, and can be used to detect heart arrhythmias of the patient; electrocardiography is a known means of observing heartbeat patterns) (page 16 lines 19-26); administering acoustic shock waves or pressure pulses directed to an area near the heart or the chest of the patient while observing the heartbeat pattern on the electrocardiogram monitoring device (cardiac rhythm sensors can be used to observe the heartbeat at the same time as the shock wave transducer stimulates the heart with shock waves in the thoracic area) (Figs. 4-11; page 16 lines 33-34; page 17 lines 1-10; page 24 lines 1-20; page 33 lines 15-18).
Peters does not disclose wherein said administration causes cardiac tissue of the patient to be exposed to converging, diverging, planar, or near-planar portions of the acoustic shock waves or pressure pulses while positioned outside a geometric focal volume or focal point of the acoustic shock waves or pressure pulses.
However, Schultheiss teaches a method of using acoustic shock waves to stimulate an organ such as the heart (Schultheiss; abstract) including wherein said administration causes cardiac tissue of the patient to be exposed to converging, diverging, planar, or near-planar portions of the acoustic shock waves or pressure pulses while positioned outside a geometric focal volume or focal point of the acoustic shock waves or pressure pulses (the substance, i.e. the heart, can be stimulated by acoustic shock waves that are convergent, divergent, or near planar; the emitted shock waves can have a focal point the extends beyond the target treatment site) (Schultheiss; abstract; para. [0028]; para. [0127]).
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 Peters administration such that said administration causes cardiac tissue of the patient to be exposed to converging, diverging, planar, or near-planar portions of the acoustic shock waves or pressure pulses while positioned outside a geometric focal volume or focal point of the acoustic shock waves or pressure pulses, as taught by Schultheiss, for the purpose of reducing or eliminating a localized intensity zone associated with noticeable pain while providing a wide or enlarged treatment volume at a variety of depths more closely associated with high energy focused wave treatment (Schultheiss; para. [0127]).
Peters does not disclose stopping the administration of the acoustic shock waves or pressure pulses when the heartbeat pattern being observed changes to a regular heartbeat pattern as displayed on the electrocardiogram monitoring device.
However, Haluska teaches a method of using a cardiac stimulator (Haluska; abstract) wherein which it stops administering the stimulation when the heartbeat pattern being observed is changed to a regular heartbeat pattern (stimulator detects and distinguishes between normal and abnormal tachycardias, and delivers therapies if abnormal; stimulator provides the necessary stimuli to pace the heart until normal heart activity is detected) (Haluska; col. 8 lines 35-55; col. 10 lines 30-42; claims 21, 23). Moreover, Loeb teaches stopping the administration of the stimulus when the heartbeat pattern being observed changes to a regular heartbeat pattern as displayed on the electrocardiogram monitoring device (when normal heart rhythm returns as shown by the ECG signal on the display screen 20, the stimulation for abnormal heart rhythm is stopped) (Loeb; Fig. 3; para. [0113]).
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 Peters method to include stopping the administration of the stimulation when the heartbeat pattern being observed changes to a regular heartbeat pattern, as taught by Haluska, for the purpose of ensuring a patient is not treated unless necessary (Haluska; col. 2 lines 18-41). Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the modified Peters method to include the heartbeat pattern being observed changes to a regular heartbeat pattern as displayed on the electrocardiogram monitoring device, as taught by Loeb, for the purpose of enabling a healthcare provider to be informed regarding the patient’s restored ECG pattern (Loeb; para. [0046]).
With this modification, the modified Peters method would thus teach stopping the administration of the acoustic shock waves or pressure pulses when the heartbeat pattern being observed changes to a regular heartbeat pattern as displayed on the electrocardiogram monitoring device (the modified Peters wearable device 100 would stop administering extracorporeal shock waves when its ECG, modified by Loeb to display the heartbeat patterns including as the heartbeat returns to a normal pattern, detects the normal heartbeat pattern as taught by Haluska) (Peters, Figs. 1 and 4-11, page 16 lines 33-34, page 17 lines 1-10, page 33 lines 15-18; Haluska, col. 8 lines 35-55, col. 10 lines 30-42, claims 21, 23; Loeb, Fig. 3, para. [0046], para. [0113]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Peters in view of Schultheiss, Haluska, and Loeb as applied to claim 3 above, and further in view of Freeman et al. (US 2017/0296057 A1).
Regarding claim 4, the modified Peters teaches the invention as previously claimed, including further comprises the steps of: when a recurrence of the irregular heartbeat pattern is detected, repeating the administration of the shock waves or pressure pulses to reset the heartbeat pattern to the regular heartbeat pattern (the modified Peters wearable device 100 would use the ECG to monitor the patient for another abnormal heart pattern to be treated after returning to a normal heart pattern, as taught by Loeb, and administer the Peters shock waves stimulation again when the heart pattern is abnormal as taught by Haluska) (Peters, Figs. 1 and 4-11, page 16 lines 33-34, page 17 lines 1-10, page 33 lines 15-18; Haluska, col. 8 lines 35-55, col. 10 lines 30-42, claims 21, 23; Loeb, Fig. 3, para. [0046], para. [0113]), but does not teach having the patient wear a portable heart monitor after the treatment to detect for a recurrence of the irregular heartbeat pattern for a period of at least three days.
However, Freeman teaches an ambulatory medical device for storing patient data such as ECG readings and heart rate (Freeman; para. [0007]; para. [0010]) including having the patient wear a portable heart monitor after the treatment to detect for a recurrence of the irregular heartbeat pattern for a period of at least three days (ambulatory medical device 102 is worn by the patient with sensors that monitor the patient over an extended time period of days, weeks, or months; ambulatory medical device 102 can include wearable defibrillators to track a patient’s ECG data over time, including when a patient experiences a cardiac event such as ventricular fibrillation) (Freeman; Fig. 13; para. [0046]; para. [0105]).
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 modified Peters method to include having the patient wear a portable heart monitor after the treatment to detect for a recurrence of the irregular heartbeat pattern for a period of at least three days, as taught by Freeman, for the purpose of tracking information that can be useful to a hospital practitioner, as well as enabling treatment to be provided to a patient in an emergency (Freeman; para. [0007]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Peters in view of Schultheiss, Haluska, and Loeb as applied to claim 2 above.
Regarding claim 13, the modified Peters teaches the invention as previously claimed, but does not explicitly disclose wherein the area at or near the heart or chest receives between 100 and 2000 of the acoustic shock waves or pressure pulses per therapy session [for the treatment of irregular heart rhythm, atrial fibrillation, or abnormal heart rhythm].
However, Peters does disclose the treatment of other heart diseases can include wherein the area at or near the heart or chest receives between 100 and 2000 of the acoustic shock waves or pressure pulses per therapy session (treating end-stage coronary artery disease can involve 1200 impulses per session around the patient’s heart area; treating chronic ischemic heart failure can involve 300 impulses per session around the patient’s heart area) (Peters; page 25 lines 25-33). Moreover, Peters can also be used to treat irregular heart rhythm, atrial fibrillation, or abnormal heart rhythm with acoustic shock waves or pressure pulses (wearable device for generating extracorporeal shock waves for treating heart disease, such as atrial fibrillation and ventricular tachycardia) (Peters; abstract; page 2 lines 14-16; page 29 lines 9-16).
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 Peters method for the treatment of irregular heart rhythm, atrial fibrillation, or abnormal heart rhythm to include wherein the area at or near the heart or chest receives between 100 and 2000 of the acoustic shock waves or pressure pulses per therapy session, as suggested by Peters, for the purpose of providing a specific number of acoustic shock waves or pressure pulses which one of ordinary skill in the art would recognize as suitable for treating other heart diseases (Peters; page 25 lines 25-33), and so could feasibly assume would also be suitable for treating irregular heart rhythm, atrial fibrillation, or abnormal heart rhythm.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Peters in view of Schultheiss, Haluska, and Loeb as applied to claim 9 above, and further in view of Warlick et al. (US 2019/0209431 A1).
Regarding claim 15, as best understood, the modified Peters teaches the invention as previously claimed, but does not disclose wherein the repeated administrations are performed according to a schedule extending over at least three weeks, and wherein subsequent administrations are performed at intervals greater than the intervals between earlier administrations.
However, Warlick teaches a treatment using acoustic shock waves or pressure pulses for treating the heart (Warlick; abstract; para. [0113]; para. [0132]) including wherein the repeated administrations are performed according to a schedule extending over at least three weeks, and wherein subsequent administrations are performed at intervals greater than the intervals between earlier administrations (repeated treatments on a schedule over a period of three or more weeks, and treatments can be repeated over time as a treatment protocol over longer durations of time between repeated treatments) (Warlick; para. [0013]).
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 Peter method to include wherein the repeated administrations are performed according to a schedule extending over at least three weeks, and wherein subsequent administrations are performed at intervals greater than the intervals between earlier administrations, as taught by Warlick, for the purpose of treating symptoms as they reoccur and as a preventative (Warlick; para. [0076]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Peters in view of Schultheiss, Haluska, and Loeb as applied to claim 17 above, and further in view of Freeman.
Regarding claim 18, as best understood, the modified Peters teaches the invention as previously claimed, including when recurrence of the irregular heartbeat pattern is detected, repeating administration of the acoustic shock waves or pressure pulses to restore the heartbeat pattern to the regular heartbeat pattern (the modified Peters wearable device 100 would use the ECG to monitor the patient for another abnormal heart pattern to be treated after returning to a normal heart pattern, as taught by Loeb, and administer the Peters shock waves stimulation again when the heart pattern is abnormal until normal as taught by Haluska) (Peters, Figs. 1 and 4-11, page 16 lines 33-34, page 17 lines 1-10, page 33 lines 15-18; Haluska, col. 8 lines 35-55, col. 10 lines 30-42, claims 21, 23; Loeb, Fig. 3, para. [0046], para. [0113]), but does not teach having the patient wear a portable heart monitor after treatment to detect recurrence of the irregular heartbeat patterns for a period of at least three days.
However, Freeman teaches an ambulatory medical device for storing patient data such as ECG readings and heart rate (Freeman; para. [0007]; para. [0010]) including having the patient wear a portable heart monitor after treatment to detect recurrence of the irregular heartbeat patterns for a period of at least three days (ambulatory medical device 102 is worn by the patient with sensors that monitor the patient over an extended time period of days, weeks, or months; ambulatory medical device 102 can include wearable defibrillators to track a patient’s ECG data over time, including when a patient experiences a cardiac event such as ventricular fibrillation) (Freeman; Fig. 13; para. [0046]; para. [0105]).
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 modified Peters method to include having the patient wear a portable heart monitor after treatment to detect recurrence of the irregular heartbeat patterns for a period of at least three days, as taught by Freeman, for the purpose of tracking information that can be useful to a hospital practitioner, as well as enabling treatment to be provided to a patient in an emergency (Freeman; para. [0007]).
Response to Arguments
Applicant's arguments filed 6/9/2026 have been fully considered but they are not persuasive.
On pages 8-9 in the “Claim Objections” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the claim objections of the previous office action. The Examiner agrees, and has thus withdrawn those claim objections. However, the newly amended claims have raised new claim objections as detailed above.
On pages 9-13 in the “Rejections Under 35 U.S.C. Section 112” section of the Applicant’s remarks, the Applicant argues that the claims have been amended to overcome the 35 U.S.C. 112(b) rejections of the previous office action. The Examiner partially agrees, and has thus withdrawn those 35 U.S.C. 112(b) rejections which were sufficiently addressed. However, the unaddressed 35 U.S.C. 112(b) rejections are being maintained as detailed above.
Applicant’s arguments on pages 13-19 of the Applicant’s remarks with respect to the newly amended independent claims 1 and 17 have been considered but are moot in view of new grounds of rejection with new additional Schultheiss reference being used in the current rejection as discussed above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE M PINDERSKI whose telephone number is (571)272-7032. The examiner can normally be reached Monday-Friday 7:00-4:00.
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/JACQUELINE M PINDERSKI/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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