DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 28 & 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 6 of U.S. Patent No. 12,138,444. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following analysis:
Claim 28; (present application) 18/906,254
Claim 1; U.S. Pat. No 12,138,444
A wearable defibrillator for monitoring…arrhythmias…
A wearable defibrillator for monitoring…arrhythmias…
…a plurality of ECG sensing electrodes…
…a plurality of sensing electrodes configured to generate ECG data…
…one or more audio device comprising a microphone…
…one or more audio devices comprising a microphone…
…one or more processors configured to detect…ECG data…cause an audible alarm to be produced…in response to detecting that the patient is experiencing a life threatening arrhythmia…
…one or more processors configured to determine…whether the patient is experiencing treatable arrhythmia, cause…audible alarm…in response to determining that the patient is experiencing the treatable arrhythmia…
...identify a level of background noise detected by the microphone...
…identify whether a predetermined level of background noise exists…detected by the microphone
…increase a confidence that the detected life threatening arrhythmia is appropriate for treatment…
…delay a delivery of treatment to the patient
The present claims and claims of U.S. Pat. ‘444 merely recite the complementary operational condition of the same back-ground noise evaluation. Whereas the patented claims delay treatment when elevated background noise is detected, the instant claims increase confidence in the arrhythmia determination and accelerate treatment when little or no background noise is detected. These opposing decision outcomes represent predictable alternatives within the same noise-based treatment control strategy and would have been obvious to one of ordinary skill in the art seeking to optimize treatment timing based on upon ambient noise conditions.
Accordingly, the instant claims define no more than an obvious variation of the invention claimed in the patent and are therefore unpatentable under the judicially created doctrine of obviousness-type double patenting;
Claims 28 & 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,083,886. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following analysis:
Claim 28; (present application) 18/906,254
Claim 1; U.S. Pat. No 11,083,886
A wearable defibrillator for monitoring…arrhythmias…
A wearable defibrillator…
…a plurality of ECG sensing electrodes…
…a plurality of ECG electrodes configured to…sense ECG information…
…one or more audio device comprising a microphone…
…at least one audio device…including a microphone
…one or more processors configured to detect…ECG data…cause an audible alarm to be produced…in response to detecting that the patient is experiencing a life threatening arrhythmia…
…at least one processor operatively connected to the plurality of ECG electrodes…and the at least one audio device…configured to in a setup phase, receive by the microphone…the audio input comprising a voice recording…
...identify a level of background noise detected by the microphone...
…cause the audio output device to provide the audio output by playing back the voice recording.
…increase a confidence that the detected life threatening arrhythmia is appropriate for treatment…
The instant claims and the patent claims of U.S. Pat. No. ‘886 are directed to the same inventive concept of a wearable defibrillator including an audio subsystem configured to provide patient-specific audio output during operation. The differences between the claimed subject matter merely recite obvious variations in the manner in which the patient-specific audio output is generated or utilized and do not render the present claimed invention patentably distinct.
Accordingly, the instant claims define no more than an obvious variation of the invention claimed in the patent and are therefore unpatentable under the judicially created doctrine of obviousness-type double patenting;
Claims 28 & 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1of U.S. Patent No. 10,426,946. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following analysis:
Claim 28; (present application) 18/906,254
Claim 1; U.S. Pat. No 10,426,946
A wearable defibrillator for monitoring…arrhythmias…
A wearable defibrillator…
…a plurality of ECG sensing electrodes…
…a plurality of ECG electrodes configured to sense a cardiac condition…
…one or more audio device comprising a microphone…
…at least one audio device…including a microphone…and a speaker configured to output one or more alarms signaling that treatment is about to be provided…
…one or more processors configured to detect…ECG data…cause an audible alarm to be produced…in response to detecting that the patient is experiencing a life threatening arrhythmia…
…at least one processor operatively connected to the plurality of ECG electrodes…and the at least one audio device…configured to monitor the sensed cardiac condition…
...identify a level of background noise detected by the microphone...
…increase a volume of the one or more alarms when the microphones senses…
…increase a confidence that the detected life threatening arrhythmia is appropriate for treatment…
The instant claims and the patent claims of U.S. Pat. No. ‘946 are directed to the same inventive concept of a wearable defibrillator including an audio subsystem configured to provide patient-specific audio output during operation. The differences between the claimed subject matter merely recite obvious variations in the manner in which the patient-specific audio output is generated or utilized and do not render the present claimed invention patentably distinct.
Accordingly, the instant claims define no more than an obvious variation of the invention claimed in the patent and are therefore unpatentable under the judicially created doctrine of obviousness-type double patenting;
Claims 28 & 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 17 of U.S. Patent No. 9,492,676. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following analysis:
Claim 28; (present application) 18/906,254
Claim 1; U.S. Pat. No 9,492,676
A wearable defibrillator for monitoring…arrhythmias…
An external device…
…a plurality of ECG sensing electrodes…
…at least one sensor configured to…sense data indicative of a cardiac condition
…one or more audio device comprising a microphone…
…an operator interface device…
…one or more processors configured to detect…ECG data…cause an audible alarm to be produced…in response to detecting that the patient is experiencing a life threatening arrhythmia…
…at least one processor…configured to allow for customization of information…to be delivered via the operator interface device
...identify a level of background noise detected by the microphone...
…increase a confidence that the detected life threatening arrhythmia is appropriate for treatment…
The instant claims and the patent claims of U.S. Pat. No. ‘676 are directed to the same inventive concept of an external wearable cardiac monitoring device having a processor configure to customize information communicated to a patient through an output interface. The differences between the claimed subject matter merely recite obvious variations concerning the particular form and content of the customized output message and therefore do not render the presently claimed invention patentably distinct.
Accordingly, the instant claims define no more than an obvious variation of the invention claimed in the patent and are therefore unpatentable under the judicially created doctrine of obviousness-type double patenting;
Claims 28 & 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,774,917. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following analysis:
Claim 28; (present application) 18/906,254
Claim 1; U.S. Pat. 8,774,917
A wearable defibrillator for monitoring…arrhythmias…
An wearable defibrillator comprising…
…a plurality of ECG sensing electrodes…
…a plurality of sensors configured to…sense data indicative of a medical condition of a patient…
…one or more audio device comprising a microphone…
…at least one audio device…including a microphone…
…one or more processors configured to detect…ECG data…cause an audible alarm to be produced…in response to detecting that the patient is experiencing a life threatening arrhythmia…
…at least one processing unit…configured to monitor the data sensed…in response to the audio input being a voice command…
...identify a level of background noise detected by the microphone...
…increase a confidence that the detected life threatening arrhythmia is appropriate for treatment…
The instant claims and the patent claims of U.S. Pat. No. ‘917 are directed to the same inventive concept of a wearable defibrillator including an audio subsystem configured to provide patient-specific audio output during operation. The differences between the claimed subject matter merely recite obvious variations in the manner in which the patient-specific audio output is generated or utilized and do not render the present claimed invention patentably distinct.
Accordingly, the instant claims define no more than an obvious variation of the invention claimed in the patent and are therefore unpatentable under the judicially created doctrine of obviousness-type double patenting; and
Claims 28 & 44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,774,917. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following analysis:
Claim 28; (present application) 18/906,254
Claim 1; U.S. Pat. 8,369,944
A wearable defibrillator for monitoring…arrhythmias…
A wearable defibrillator comprising…
…a plurality of ECG sensing electrodes…
…a least one sensor…
…one or more audio device comprising a microphone…
…at least one audio device…
…one or more processors configured to detect…ECG data…cause an audible alarm to be produced…in response to detecting that the patient is experiencing a life threatening arrhythmia…
…at least one processing unit…configured to cause at least one responsiveness test including a voice recognition…to uniquely identify the patient as having provided the audio input in response to the voice recognition responsiveness test…
...identify a level of background noise detected by the microphone...
…increase a confidence that the detected life threatening arrhythmia is appropriate for treatment…
The instant claims and the patent claims of U.S. Pat. No. ‘917 are directed to the same inventive concept of a wearable defibrillator including an audio subsystem configured to provide patient-specific audio output during operation. The differences between the claimed subject matter merely recite obvious variations in the manner in which the patient-specific audio output is generated or utilized and do not render the present claimed invention patentably distinct.
Accordingly, the instant claims define no more than an obvious variation of the invention claimed in the patent and are therefore unpatentable under the judicially created doctrine of obviousness-type double patenting;
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 28-53 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Heilman et al. (US 5,078,134) in view of Osorio et al. (US 2004/0133119) and further in view of Pinhas et al. (WO 2007/052108).
Claim 28.
A wearable defibrillator…
E.G. Heilman et al. discloses a patient worn automatic pacemaker (Fig 4) supported by a belt (14), vest or shoulder strap (18) for continuously monitoring a patient and automatically providing therapy [(col 2, lines 20-66), (col 5, lines 56-68) & (Fig 4)].
…a plurality of ECG sensing electrodes to generate ECG data of the patient…
E.G. Heilman et al. discloses sensing/pulse electrode assemblies (20/22) [(col 5, lines 62-67)-(col 6, lines 1-3 & 34-66)].
…one or more audio devices comprising a microphone configured to detect background noise and a speaker configured to produce an audio output;
E.G. Heilman et al. discloses a microphone (48) associated with each sensing electrode and a voice synthesizer and speakers (130/132) in which a microprocessor may issue a spoken warning to stand clear and causes treatment to begin [(col 6, lines 34-53), (col 8, lines 44-36) & (Fig 1)].
…detect…whether the patient is experiencing a life threatening arrhythmia…
E.G. Heilman et al. discloses the capability of continuously monitoring the patient for potentially lethal arrhythmias and delivering corrective and quick treatment (col 2, lines 35-50).
…cause an audible alarm to be produced as the audio output in response to detecting that the patient is experiencing the life threatening arrhythmia..
E.G. Heilman et al. discloses issuing a spoken warning to stand clear and causes treatment to begin after detection of an arrhythmia [(col 6, lines 34-53) & (col 8, lines 44-36)].
Heilman et al. does not explicitly teach the following claim limitations
Identifying a background-noise level using the microphone after life threatening arrhythmia has been detected; and
Increasing confidence in the arrhythmia determination when the identified background-noise level is low.
Osorio et al. teaches that physiological event determinations should be evaluated using signal quality and noise information before therapy is authorized. Specifically, Osorio et al. teaches measuring noise characteristics, determining whether physiological information is sufficiently reliable, excluding unreliable information, reducing false-positive detections and requiring multiple validity conditions before therapy delivery (e.g., [0093]-[0102], [0145], [0147]). Thus, Osorio et al. teaches using an additional quality metric to improve the reliability of a treatment decision.
Pinhas et al. teaches microphone-based acoustic monitoring in which ambient audio is digitally analyzed to determine background conditions. Pinhas et al. teaches evaluating acoustic signal energy and amplitude over successive frames, calculating thresholds, distinguishing background sounds, and classifying acoustic events relative to background noise (e.g., [0281]-[0283]). Thus, Pinhas et al. teaches determining a background-noise level using a microphone.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Heilman’s wearable defibrillator to incorporate Pinhas’ known microphone-based background-noise analysis while further applying Osorio’s known signal-quality validation techniques before therapy authorization, therefore predictably providing an additional indicator of the reliability of a detected arrhythmia thereby reducing inappropriate or false-positive therapy, improving patient safety, and increasing the likelihood that therapy is delivered only when clinically appropriate. Incorporating known signal-quality evaluation techniques into another physiological monitoring system to improve detection reliability merely applies a known technique to a known device yielding predictable results. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Furthermore, under the broadest reasonable interpretation consistent with the specification, the recited limitation “increasing confidence” reasonably encompasses increasing the reliability of trustworthiness of the arrhythmia determination by using an additional validation criterion before therapy. Osorio expressly teaches improving reliability of physiological determinations through signal-quality evaluation, while Pinhas et al. teaches determining background acoustic conditions from microphone data. Their combined teaches therefore satisfy the claimed limitation under the broadest reasonable interpretation.
Claim 29.
…one or more therapy pads configured to provide a treatment to the patient…
E.G. Heilman et al. discloses electrode assemblies 20, including pulse electrodes 32, each having a skin contact area (col 6, lines 60-66).
Claim 30.
…one or more processors…configured to accelerate the treatment to the patient in response to identifying the little to no background noise is detected.
Heilman et al. discloses automatically delivering therapy after detection of a treatable arrhythmia [(col 2, lines 20-66), (col 5, lines 56-68) & (Fig 4)].
Osorio et al. teaches utilizing signal-quality information as an additional validity criterion before therapy authorization to improve reliability and reduce false detections ([0093]-[0102], [0145], [0147]).
It would have been obvious to cause therapy to proceed more quickly when the additional acoustic validation indicates little or no background noise because such conditions indicate greater reliability of the physiological determination, thereby reducing unnecessary delay while maintaining reliable therapy decision KSR Int’l Co. v. Teleflex Inc., 550 U.S. at 417 (2007).
Claim 31.
…one or more processors…configured to delay the treatment to the patient in response to identifying that a high level background noise is detected.
Heilman et al. teaches delaying therapy while issuing warnings before treatment via a microprocessor that issues a spoken warning to stand clear and causes treatment to begin [(col 6, lines 34-53), (col 8, lines 44-36) & (Fig 1)].
Pinhas et al. teaches identifying elevated background noise using microphone signal analysis (e.g., [0281]-[08283]).
Osorio et al. teaches withholding or delaying therapy until physiological information satisfies reliability criteria and multiple validity conditions (e.g., [0145], [0147]).
It would have been obvious to delay treatment while excessive background noise exists because excessive noise decreases confidence in the physiological determination and Osorio et al. taches delaying treatment until sufficient reliability is achieved.
Claim 32.
…wearable defibrillator further comprises…at least one of belt, a harness, or vest configured to permit the patient to wear the wearable defibrillator.
E.G. Heilman et al. discloses a patient worn automatic pacemaker (Fig 4) supported by a belt (14), vest or shoulder strap (18) for continuously monitoring a patient and automatically providing therapy [(col 2, lines 20-66), (col 5, lines 56-68) & (Fig 4)].
Claim 33.
…wherein the wearable defibrillator further comprises: one or more response buttons located on, in, or adjacent the belt, harness or vest of the wearable defibrillator.
E.G. Heilman et al. discloses patient-operated switches 446 where patients can response and acknowledge the onset of therapy (col 13, lines 30-55).
Claim 34.
…the one or more processors are further configured to…stop the audible alarm in response to the patient pressing at least one of the one or more response buttons.
E.G. Heilman et al. discloses the patient being able to delay treatment by depressing two switches 120, (col 8, lines 38-56).
Claim 35.
…the one or more processors are further configured to…cause at least one patient responsiveness test comprises one or more voice recognition responsiveness test, at least one button responsiveness test, or combination thereof.
E.G. Heilman et al. discloses patient-operated switches 446 where patients can response and acknowledge the onset of therapy (col 13, lines 30-55).
Claim 37.
…the one or more processors are further configured to cause the treatment to be provided to the patient via the one or more therapy pads in response to the patient failing to press the at least on or more response buttons after the audible alarm.
E.G. Heilman et al. discloses beginning treatment if the patient looses consciousness and releases the switch (col 8, lines 38-56).
Claim 38.
…one or more processors are configured to increase a volume of the alarm in response to a high level background noise…
E.G. Heilman et al. discloses audio warning generation [(col 6, lines 34-53) & (col 8, lines 44-36)].
Pinhas et al. teaches determining the amount of ambient acoustic noise ([0281]-[0283]).
Therefore, it would have been obvious to increase alarm volume when elevated ambient noise is detected so that the patient can perceive the warning despite the noisy environment, which is a well-known predictable design choice. KSR.
Claim 39.
…wherein the background noise comprises environmental noise
Expressly suggested by Pinhas et al., which distinguishes environmental sounds including television, radio, etc. and other ambient noise ([0281]-[0283]).
Claim 40.
…wherein background noise comprises patient noise.
E.G. Pinhas ([0281]-[0283]).
Claim 41.
…further comprising a communication device configured to connect the wearable defibrillator to a central location.
E.G. Heilman et al. discloses communication of patient information to remote monitoring equipment
Claim 42.
…wherein the one or more processors are further configured to transmit, via the communication device, the ECG data to the central location.
E.G. Heilman et al. disclose transmission of monitored ECG information to remote equipment, Col 17-19.
Claim 43.
…wherein the one or more processors are further configured to record an arrhythmia condition of the patient; and communicate, the recorded arrhythmia condition to the central location.
E.G. Heilman et al. discloses storing and communicating detected arrhythmia information as part of the monitoring system, (col 17-19).
Claim 44-53
Claims 44-53 are directed to a computer-readable memory storing program instructions implementing substantially the same functional limitations recited in claims 28-43.
Under the broadest reasonable interpretation, a program embodied in computer-readable memory performing the same processor operations is met by the software-controlled microprocessor disclosed by Heilman et al. as modified by Osorio et al. and Pinhas et al. for the reasons discussed with respect to claim 28-40.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bock (US 2002/0143266) was reviewed and is considered pertinent to the claimed subject matter because it teaches ECG-based detection of cardiac arrhythmias and recognizes problems associated with false alarms and alarm-based patient monitoring. The reference was not relied upon in the rejection because it does not teach or suggest using microphone-detected background noise to adjust confidence in an arrhythmia determination or treatment decision as claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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