DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, 3, 5, 7, 9, and 17 are objected to because of the following informalities:
Claim 1 recites “the treatment” in line 2 and is suggested to read --the treatment method-- in order to more clearly reference how the limitation was originally claimed.
Claim 1 recites “the patient’s heart or chest” in lines 3-4 and is suggested to read --a heart or a chest of the patient-- in order to ensure proper antecedent basis.
Claim 3 recites “the patient’s heart or chest” in lines 7-8 and is suggested to read --the heart or the chest of the patient-- in order to ensure proper antecedent basis.
Claim 5 recites “the patient’s skin” in line 2 and is suggested to read --skin of the patient-- in order to ensure proper antecedent basis.
Claim 7 recites “including, but not limited to VEGF” in line 2 and is suggested to read --including vascular endothelial growth factor (VEGF)-- in order to be succinct and provide clarity for the acronym.
Claim 9 recites “prior to or during the medical procedure or after the medical procedure” in lines 1-2 and is suggested to read --prior to, during, or after the medical procedure-- in order to be succinct and provide clarity.
Claim 17 recites “the treatment” in line 2 and is suggested to read --the treatment method-- in order to more clearly reference how the limitation was originally claimed.
Claim 17 recites “the patient’s heart or chest” in lines 7-8 and is suggested to read --a heart or a chest of the patient-- in order to ensure proper antecedent basis.
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 1-18 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.
Claim 1 recites the limitation "the step" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 2, the limitation “acoustic shock waves or pressure pulses” recited three times in lines 2, 3, and 4 is confusing, as it is unclear whether the limitation is meant to include the “acoustic shock waves or pressure pulses” of claim 1.
Regarding claim 3, the phrase "or otherwise" in line 2 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "or otherwise"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). Moreover, the limitations “an irregular heartbeat” in line 3 and “an irregular heartbeat pattern” in line 5 are confusing, as it is unclear whether these limitations are meant to be the same limitation and/or meant to be the same as the “irregular heart rhythm” of claim 1. The limitation "the heartbeat pattern" is recited in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the limitations “acoustic shock waves or pressure pulses” in line 7 and “an area” in line 7 are confusing, as it is unclear whether these limitations are meant to be the same as “acoustic shock waves or pressure pulses” and “an area” of claim 1, respectively.
Regarding claim 4, the limitation “any irregular heartbeat patterns” in line 3 is confusing, as it is unclear whether this is meant to include “an irregular heartbeat” in claim 3, “an irregular heartbeat pattern” in claim 3, and/or “irregular heart rhythm” of claim 1. Additionally, the term “few” in line 3 is a relative term which renders the claim indefinite. The term “few” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the number of days being claimed is rendered indefinite. Moreover, the limitation “if” in line 4 is confusing, as it is unclear whether the following limitations are required or not for the claimed invention. It is suggested to use claim language such as --when-- in order to avoid such indefiniteness. Furthermore, the limitation “a regular heartbeat pattern” in line 5 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “a regular heartbeat pattern” of claim 3.
Claim 6 recites the limitation "the stimulating" in line 1. There is insufficient antecedent basis for this limitation in the claim. Moreover, the phrase "other" in line 2 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "other"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
Regarding claim 9, the limitation “of claim 2, is repeated” in line 1 is confusing, as it is unclear as to what is being repeated. Moreover the limitation "the medical procedure" is recited in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the range" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the limitation “an energy density” in lines 1-2 is confusing, as it is unclear whether this is meant to include “an energy density” of claim 11. Moreover, the limitation "the range" in line 2 is recited. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 13, the limitation “each subjected area” in line 1 is confusing, as it is unclear whether this is meant to include “an area” of claim 1. Moreover, the limitation “acoustic shock waves or pressure pulses” in line 2 is confusing, as it is unclear whether the limitation is meant to include the “acoustic shock waves or pressure pulses” of claim 1.
Regarding claim 14, the limitation “an acoustic shock wave” in line 4 is confusing, as it is unclear whether the limitation is meant to be a part of or separate from “acoustic shock waves or pressure pulses” in claim 1.
Claim 15 recites the limitation "the number" in line 1. There is insufficient antecedent basis for this limitation in the claim. Moreover, the limitations “treatments” in line 2 and “repeated treatments” in lines 3-4 are confusing, as it is unclear whether these limitations are meant to be a part of or separate from “the treatment method” in claim 1 and/or “repeated treatments” in claim 15. Additionally, the limitation “can be” in line 2 is confusing, as it is unclear whether the following limitations are required or not for the claimed invention. Furthermore, the limitation “longer durations” in line 3 is confusing, as it is unclear as to what is being compared. In other words, it is not clear what the “durations” are “longer” than in comparison.
Claim 16 recites the limitation "the range" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "the steps" in line 2. There is insufficient antecedent basis for this limitation in the claim. Moreover, the phrase "or otherwise" in line 3 renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "or otherwise"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d). Additionally, the limitation "the heartbeat pattern" is recited in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the limitation “an irregular heartbeat pattern” in line 6 are confusing, as it is unclear whether this limitation is meant to be the same as or different from the “irregular heart rhythm” in lines 1-2. The limitation "the heartbeat pattern" is recited in lines 4-5.
Regarding claim 18, the limitation “any irregular heartbeat patterns” in line 3 is confusing, as it is unclear whether this is meant to include “irregular heart rhythm” and/or “an irregular heartbeat pattern” in claim 17. Additionally, the term “few” in line 3 is a relative term which renders the claim indefinite. The term “few” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the number of days being claimed is rendered indefinite. Moreover, the limitation “if” in line 4 is confusing, as it is unclear whether the following limitations are required or not for the claimed invention. It is suggested to use claim language such as --when-- in order to avoid such indefiniteness. Furthermore, the limitation “a regular heartbeat pattern” in line 5 is confusing, as it is unclear whether this limitation is meant to be the same as or different from “the heartbeat pattern” of claim 17.
Any remaining claims are rejected based on their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5-12, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peters et al. (WO 2023/285494 A1).
Regarding claim 1, as best understood, 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); the treatment comprises the step of: administering acoustic shock waves or pressure pulses directed to an area near the patient's heart or chest (shock wave therapy administered to a thoracic region of a user) (Figs. 4-11; page 24 lines 1-20; page 33 lines 15-18).
Regarding claim 2, as best understood, Peters discloses further comprises the steps of: activating acoustic shock waves or pressure pulses of an acoustic shock wave or pressure pulse generator to emit acoustic shock waves or pressure pulses (wearable device 100 for generating extracorporeal shock waves) (Figs. 1, 4-11; page 33 lines 15-18); subjecting the area at or near the heart or chest to acoustic shock waves or pressure pulses stimulating the area (wearable device 100 generates extracorporeal shock waves at the thoracic region of the user) (Figs. 1, 4-11; page 33 lines 15-18); and wherein the emitted acoustic shock waves or pressure pulses are focused acoustic shock waves or pressure pulses (high intensity focused ultrasound; generated shock wave can be controlled regarding focus) (page 9 lines 26-31; page 12 lines 23-25; page 13 lines 7-9).
Regarding claim 5, Peters discloses wherein the shock wave or pressure pulse generator is acoustically coupled to the patient's skin using a coupling gel or liquid (acoustic impedance matching liquid such as ultrasound gel couples the wearable device to the user’s skin) (page 31 lines 26-28; page 32 lines 9-13).
Regarding claim 6, as best understood, Peters discloses wherein the stimulating of the area causes a release of nitric oxide, secretion of digestive enzymes, hormones and other fluids reduces inflammation and absorbs 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 other fluids to reduce inflammation and absorb plaque in the patient. As Peters teaches that stimulation step, Peters would also naturally and inherently function as claimed.) (Figs. 4-11; page 24 lines 1-20; page 27 lines 26-29; page 33 lines 15-18).
Regarding claim 7, as best understood, Peters discloses wherein the stimulating of the area causes a release of growth factors including, but not limited to VEGF (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.) (Figs. 4-11; page 24 lines 1-20; page 27 lines 26-29; page 33 lines 15-18).
Regarding claim 8, Peters discloses wherein the stimulating of 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.) (Figs. 4-11; page 24 lines 1-20; page 27 lines 26-29; page 33 lines 15-18).
Regarding claim 9, as best understood, Peters discloses is repeated one or more times prior to or during the medical procedure or after the 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) (page 19 lines 21-27; page 21 lines 1-9; page 25 lines 25-33).
Regarding claims 10-12, as best understood, Peters discloses 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 the range of 0.01 mJ/mm2 to 1.0 mJ/mm2; wherein the low energy soft waves have an energy density in the 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) (page 5 lines 33-34; page 25 lines 25-33).
Regarding claim 14, as best understood, Peters discloses wherein the emitted acoustic shock waves or pressure pulses are focused from a source without a lens (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) (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 an acoustic shock wave (shock wave transducer unit 114 includes an electrohydraulic source, a piezoelectric source, and/or an electromagnetic source) (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) (page 16 lines 6-10).
Regarding claim 16, as best understood, Peters discloses wherein the emitted acoustic shock waves or pressure pulses have an energy density in the 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).
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Peters as applied to claim 1 above, and further in view of Haluska et al. (US 4,830,006) and Loeb et al. (US 2005/0075531 A1).
Regarding claim 3, as best understood, Peters discloses the invention as previously claimed, including further comprises the steps of: attaching or otherwise connecting an electrocardiogram monitoring device to the patient suspected of having an irregular heartbeat (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 the heartbeat pattern and confirming an irregular heartbeat pattern exists (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; the cardiac rhythm detection sensor would have to have been activated in order to function) (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 an area near the patient's heart or chest (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), but does not disclose stop administering the acoustic shock waves or pressure pulses when the heartbeat pattern being observed is changed 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 administering the stimulus when the heartbeat pattern being observed is changed 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 administering the stimulation when the heartbeat pattern being observed is changed 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 is changed 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 stop administering the acoustic shock waves or pressure pulses when the heartbeat pattern being observed is changed 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 Haluska and Loeb as applied to claim 3 above, and further in view of Freeman et al. (US 2017/0296057 A1).
Regarding claim 4, as best understood, the modified Peters teaches the invention as previously claimed, including further comprises the steps of: if a recurrence occurs, repeat the administering of the shock waves or pressure pulses to reset the irregular heartbeat pattern to a 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 look for a recurrence of any irregular heartbeat patterns for a period of a few days or more.
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 look for a recurrence of any irregular heartbeat patterns for a period of a few days or more (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 look for a recurrence of any irregular heartbeat patterns for a period of a few days or more, 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 as applied to claim 2 above.
Regarding claim 13, as best understood, Peters discloses the invention as previously claimed, but does not explicitly disclose wherein each subjected area receives between 100 and 2000 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 each subjected area receives between 100 and 2000 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 each subjected area receives between 100 and 2000 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 as applied to claim 9 above, and further in view of Warlick et al. (US 2019/0209431 A1).
Regarding claim 15, as best understood, Peters discloses the invention as previously claimed, but does not disclose wherein the number of repeated treatments occur on a schedule over a period of three or more weeks, and treatments can be repeated over time as an irregular heartbeat prevention protocol over longer durations of time between repeated treatments.
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 number of repeated treatments occur on a schedule over a period of three or more weeks, and treatments can be repeated over time as an irregular heartbeat prevention protocol over longer durations of time between repeated treatments (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 number of repeated treatments occur on a schedule over a period of three or more weeks, and treatments can be repeated over time as an irregular heartbeat prevention protocol over longer durations of time between repeated treatments, as taught by Warlick, for the purpose of treating symptoms as they reoccur and as a preventative (Warlick; para. [0076]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Peters in view of Haluska and Loeb.
Regarding claim 17, as best understood, 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); the treatment comprises the steps of: attaching or otherwise connecting an electrocardiogram monitoring device to the patient suspected of having an irregular heartbeat (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 the heartbeat pattern and confirming an irregular heartbeat pattern exists (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; the cardiac rhythm detection sensor would have to have been activated in order to function) (page 16 lines 19-26); administering acoustic shock waves or pressure pulses directed to an area near the patient's heart or chest 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 to stop administering the acoustic shock waves or pressure pulses when the heartbeat pattern being observed is changed 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 administering the stimulus when the heartbeat pattern being observed is changed 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 administering the stimulation when the heartbeat pattern being observed is changed 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 is changed 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 to stop administering the acoustic shock waves or pressure pulses when the heartbeat pattern being observed is changed 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 18 is rejected under 35 U.S.C. 103 as being unpatentable over Peters in view of 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 if a recurrence occurs, repeat the administering of the shock waves or pressure pulses to reset the irregular heartbeat pattern to a 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 the treatment to look for a recurrence of any irregular heartbeat patterns for a period of a few days or more.
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 look for a recurrence of any irregular heartbeat patterns for a period of a few days or more (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 look for a recurrence of any irregular heartbeat patterns for a period of a few days or more, 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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5,291,894 by Nagy is considered to be relevant as it discloses an apparatus for treating a patient’s blood circulation with acoustic waves, and which monitors heart rate before and after treatment.
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