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 .
Priority
The present application claims priority to Provisional Patent Application 62/425,071, US Patent Application 14/941,592, US Patent Application 14/461,670, US Patent Application 14/743,882, US Patent Application 14/189,789, and Provisional Patent Application 61/769,098. The earliest application supporting the subject matter of providing no alarm with the user interface while determining whether a validation criterion is met, is Provisional Application 62/425,071. Therefore, for the purpose of examination, the priority date of the present application will be considered to be the application date of that application, 21 November 2016.
Response to Amendment
The preliminary amendment filed 10 October 2024 has been acknowledged. Claims 21-40 are new.
Claim Objections
Claims 21-40 are objected to because of the following informalities: the claims recite in various locations “arrythmia” which is a misspelling of “arrhythmia”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21, 25-27, 31, and 36-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib (US Publication no. 2013/0231711).
In regard to claim 21, Kaib disclose a method to operate a wearable cardioverter defibrillator 100 (WCD), the WCD including a support structure worn by a patient, an energy storage module to store an electrical charge (para 44), a discharge circuit coupled to the energy storage module (para 48-49, a measurement circuit (para 46, sensors 110, 135), a processor (para 45, controller 105), and a user interface that includes a speaker (para 56), the method comprising (para 44-46):
monitoring a physiological signal of a patient with the measurement circuit to detect cardiac arrythmia when the patient is wearing the support structure (para 46, sensor 110 detects cardiac information; para 59, 68, 71, and figures 5 and 6);
determining with the processor whether a validation criterion is met in response to detection of a cardiac arrythmia (para 53, 68, controller 105 uses a confidence based arrhythmia detection algorithm; para 71-72, motion signal is used in the confidence based arrhythmia detection algorithm to validate arrhythmia detection);
providing an opening human perceptible indication (HPI) with the user interface during said determining (para 71, and figure 5, upon valid arrhythmia detection, a voice message is provided to patient); and
delivering a shock to the patient from the energy storage module by the discharge circuit (para 73, controller 105 processes the sensed cardiac information to detect life-threatening arrhythmias, and can instruct treatment electrodes 115 to deliver treatment, such as a cardioverting or defibrillating shock).
In figure 6, (a separate embodiment) Kaib teaches that a warning HPI distinct from the opening HPI is delivered prior to delivering the shock in the event the validation criterion is met (steps 630 and 635; para 122-123).
Kaib is considered to substantially disclose the invention as claimed including the function for providing the opening HPI as taught in figure 5 and for providing the warning HPI as taught in figure 6. The opening HPI of Kaib serves to alert a patient that a treatable rhythm exists (para 69-71), the warning HPI of Kaib serves to alert to the application of treatment. Kaib also teaches that the opening HPI and warning HPI are different forms wherein the opening HPI is a voice message and the warning HPI includes audio, visual or haptic or combinations thereof (para 122). In view of this, Kaib is considered to communicate with the patient upon discovery of an arrhythmia and communicates with the patient again upon imminent therapy delivery. However, it appears that Kaib does not provide these communications in a single embodiment. Modification of Kaib to provide the opening HPI and also to provide a warning HPI in a single embodiment is considered to have been obvious to one of ordinary skill in the art as the combination of prior art elements according to known methods to yield predictable results. Providing both the opening HPI and warning HPI at different stages during the detection and treatment process would benefit the patient wearing the device by first confirming a treatable arrhythmia has been identified and then alerting the patient that therapy is imminent thereby improving awaremeness and facilitating an appropriate response before shock delivery.
In regard to claim 25, Kaib teaches that the patient physiological signal comprises an electrocardiogram (ECG) signal (para 51).
In regard to claim 26, Kaib does not teach specific levels of sound output or waiting periods after a determination is made regarding the validity of the arrhythmia. Kaib does teach that the controller 105 can adjust audio volume outputs of the alarm module (para 103). This adjustment may be based on the current state of the subject. Thus, it is considered to have been obvious in view of Kaib to vary the intensity of the alarm to reflect different urgency of attention to particular patient conditions as nothing more than the predictable use of a known, adjustable alarm feature to convey progressively more urgent information to the user.
In regard to claim 27, Kaib teaches causing an opening human- perceptible indication to be output responsive to detecting the cardiac arrhythmia, prior to completing the determination of whether or not the detected cardiac arrhythmia is so validated (para 71, after detection of a potential arrhythmia, producing an auditory signal to prompt the user to verify whether or not there is a problem). Kaib does not explicitly teach that the speaker is caused to output no sound while the determination being performed. However, Kaib teaches that various alarms and indications can be provided as tactile, haptic, visual, or vibration alarms (para 9, 58, and 102). It would therefore have been obvious to one having ordinary skill in the art that the speaker may not be used at all in providing alarms that are activated prior to completing the determination of whether or not the arrhythmia is validated; if a tactile or visual alarm is utilized, then the speaker would be caused to output no sound while the determination is being performed.
In regard to claim 31, Kaib disclose a wearable cardioverter defibrillator (WCD) 100, comprising:
a support structure 100 to be worn by a patient;
an energy storage module to store an electrical charge (para 44);
a discharge circuit coupled to the energy storage module (para 48-49, a measurement circuit (para 46, sensors 110, 135);
a measurement circuit (para 46, sensors 110, 135);
a user interface that includes a speaker (para 56); and
a processor (para 45, controller 105) configured to: monitor a physiological signal of a patient with the measurement circuit to detect cardiac arrythmia when the patient is wearing the support structure (para 46, sensor 110 detects cardiac information; para 59, 68, 71, and figures 5 and 6);
determine whether a validation criterion is met in response to detection of a cardiac arrythmia (para 53, 68, controller 105 uses a confidence based arrhythmia detection algorithm; para 71-72, motion signal is used in the confidence based arrhythmia detection algorithm to validate arrhythmia detection);
provide an opening human perceptible indication (HPI) with the user interface while the validation criterion is being determined (para 71, and figure 5, upon valid arrhythmia detection, a voice message is provided to patient); and
cause a shock to be delivered to the patient from the energy storage module by the discharge circuit (para 73, controller 105 processes the sensed cardiac information to detect life-threatening arrhythmias, and can instruct treatment electrodes 115 to deliver treatment, such as a cardioverting or defibrillating shock).
In figure 6, (a separate embodiment) Kaib teaches that a warning HPI distinct from the opening HPI is delivered prior to delivering the shock in the event the validation criterion is met (steps 630 and 635; para 122-123).
Kaib is considered to substantially disclose the invention as claimed including the function for providing the opening HPI as taught in figure 5 and for providing the warning HPI as taught in figure 6. The opening HPI of Kaib serves to alert a patient that a treatable rhythm exists (para 69-71), the warning HPI of Kaib serves to alert to the application of treatment. Kaib also teaches that the opening HPI and warning HPI are different forms wherein the opening HPI is a voice message and the warning HPI includes audio, visual or haptic or combinations thereof (para 122). In view of this, Kaib is considered to communicate with the patient upon discovery of an arrhythmia and communicates with the patient again upon imminent therapy delivery. However, it appears that Kaib does not provide these communications in a single embodiment. Modification of Kaib to provide the opening HPI and also to provide a warning HPI in a single embodiment is considered to have been obvious to one of ordinary skill in the art as the combination of prior art elements according to known methods to yield predictable results. Providing both the opening HPI and warning HPI at different stages during the detection and treatment process would benefit the patient wearing the device by first confirming a treatable arrhythmia has been identified and then alerting the patient that therapy is imminent thereby improving awareness and facilitating an appropriate response before shock delivery.
In regard to claim 36, Kaib teaches that the patient physiological signal comprises an electrocardiogram (ECG) signal (para 51).
In regard to claim 37, Kaib does not teach specific levels of sound output or waiting periods after a determination is made regarding the validity of the arrhythmia. Kaib does teach that the controller 105 can adjust audio volume outputs of the alarm module (para 103). This adjustment may be based on the current state of the subject. Thus, it is considered to have been obvious in view of Kaib to vary the intensity of the alarm to reflect different urgency of attention to particular patient conditions as nothing more than the predictable use of a known, adjustable alarm feature to convey progressively more urgent information to the user.
In regard to claim 38, Kaib teaches causing an opening human- perceptible indication to be output responsive to detecting the cardiac arrhythmia, prior to completing the determination of whether or not the detected cardiac arrhythmia is so validated (para 71, after detection of a potential arrhythmia, producing an auditory signal to prompt the user to verify whether or not there is a problem). Kaib does not explicitly teach that the speaker is caused to output no sound while the determination being performed. However, Kaib teaches that various alarms and indications can be provided as tactile, haptic, visual, or vibration alarms (para 9, 58, and 102). It would therefore have been obvious to one having ordinary skill in the art that the speaker may not be used at all in providing alarms that are activated prior to completing the determination of whether or not the arrhythmia is validated; if a tactile or visual alarm is utilized, then the speaker would be caused to output no sound while the determination is being performed.
Allowable Subject Matter
Claims 22-24, 28-30, 32-35, 39 and 40 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
In regard to claims 22-24 and 32-35, the subject matter claimed here in combination with the base claim was found to be allowable in Application no. 16/709,676 from which this application is a continuation. Foshee et al. (US Publication no. 2016/0082277) has been found to teach the claimed limitation at paragraph 154. However, this reference is disqualified as prior art.
In regard to claims 28-30, 39, and 40, the subject matter claimed here in combination with the base claims was found to be allowable in Application no. 16/709,676 from which this application is a continuation.
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 21 and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11 of U.S. Patent No. 9,757,579. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘579 patent recites features that anticipate the present claims. For instance, the conflict between the ‘579 patent and the present invention is shown below:
Claim 1 of the ‘579 patent:
A wearable cardioverter defibrillator (“WCD”) system, comprising:
a support structure configured to be worn by a patient; a power source;
an energy storage module configured to receive an electrical charge from the power source, and to store the received electrical charge;
a discharge circuit coupled to the energy storage module, the discharge circuit controllable to discharge the stored electrical charge so as to cause a shock to be delivered to the patient while the support structure is worn by the patient;
a measurement circuit configured to render a physiological input from a patient physiological signal;
a user interface configured to output one or more human-perceptible indications; and
a processor configured to:
detect a cardiac arrhythmia of the patient from the physiological input;
determine whether or not the detected cardiac arrhythmia is validated according to whether or not the detected cardiac arrhythmia meets a validation criterion, the validation criterion including that the detected cardiac arrhythmia is maintained for a threshold validation time; cause an opening human-perceptible indication to be output responsive to detecting the cardiac arrhythmia, prior to completing the determination of whether or not the detected cardiac arrhythmia has been thus validated according to the validation criterion; and
if the detected cardiac arrhythmia does not become thus validated according to the validation criterion, then control the discharge circuit to not deliver a shock for at least 25 min from when the opening human-perceptible indication was caused to be output;
else if the detected cardiac arrhythmia does become thus validated according to the validation criterion, then cause a warning human-perceptible indication to be output, the warning human-perceptible indication configured to communicate that a shock will be delivered imminently, the warning human-perceptible indication distinct from the opening human-perceptible indication, and then control the discharge circuit to instead deliver a shock within 3 min from when the warning human-perceptible indication was caused to be output.
Claim 31 of the present invention:
A wearable cardioverter defibrillator (WCD), comprising:
a support structure to be worn by a patient;
an energy storage module to store an electrical charge;
a discharge circuit coupled to the energy storage module;
a measurement circuit;
a user interface that includes a speaker; and a processor configured to:
monitor a physiological signal of a patient with the measurement circuit to detect cardiac arrythmia when the patient is wearing the support structure;
determine whether a validation criterion is met in response to detection of a cardiac arrythmia;
provide an opening human perceptible indication (HPI) with the user interface while the validation criterion is being determined; and
cause a shock to be delivered to the patient from the energy storage module by the discharge circuit and provide a warning HPI distinct from the opening HPI prior to delivering the shock in the event the validation criterion is met.
Above shows how claim 1 of the ‘579 patent reads on present claim 31. The recitation in claim 1 of the ‘579 that the opening human perceptible indication is provided prior to completing the validation it is considered to be similar to the present recitation of “while the validation criterion is being determined.” In view of this, the present claim is not considered to be patentably distinct over the ‘579 patent.
Similar conflict is exhibited between claim 11 of the ‘579 patent and present claim 21 which are directed to the method of use of the inventions of claim 1 of the ‘579 patent and claim 31 of the present invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Heilman et al. (US Patent no. 4,928,690) describes a wearable system for sensing and treating cardiac arrhythmia. The wearable system is also capable of emitting an alarm to the user when a detected event occurs.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN T GEDEON whose telephone number is (571)272-3447. The examiner can normally be reached M-F 8:00 am to 5:30 PM ET.
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/BRIAN T GEDEON/Primary Examiner, Art Unit 3796 6 July 2026
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