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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 91-97, 99, 103, 106-107, and 109-116 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With respect to claim 91, the claim now recites “providing, using the output device, instructions for a rescuer to unfold the flap from the first position to the second position, such that the flap is unfolded away from the waistband and positioned at the center of the chest of the patient”. The original disclosure does not provide any disclosure regarding such limitations.
With respect to independent claim 111, same issues as discussed above with respect to claim 91.
With respect to dependent claims 92-97, 99, 103, 106-107, and 109-110, and 112-116, they are rejected based upon their dependency to respective independent claims 91 and 111.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 91-97, 99, 103, 106-107, and 109-116 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaib et al US 2012/0158075 (“Kaib”) in view of Pavelka US 4,582,508 (“Pavelka”), Williams US 7,810,172 (Williams”), Centen et al US 2008/0171311(“Centen”), and Doherty US 2002/0007832 (“Doherty”).
As per claim 91, Kaib discloses a wearable medical device (wearable medical device 100/100’)(Figs. 1A-2A; [0043]-[0059]), comprising:
a garment that includes a waistband configured to be worn about a torso of a patient (harness 110)(Figs. 1A and 1B; [0045]);
a sensing electrode for receiving electrocardiogram signals indicative of cardiac activity in the patient (construed as any one of the sensor 112, i.e. “The plurality of ECG sensing electrodes 112)([0046]; also Figs. 1A and 1B; as well as [0050]);
a therapy electrode that is disposed in the garment and that is configured to apply a treatment shock to the torso of the patient (therapy electrodes 114a-114b)(Figs. 1A and 1B; [0046] and [0048]);
a CPR sensor for detecting a characteristic of a CPR therapy provided to the patient, the CPR sensor being (construed as either one of the sensor 112, that is not consider as the sensing electrode” i.e. “The plurality of ECG sensing electrodes 112, which may be dry-sensing capacitance electrodes, are used by the control unit 120 to monitor the cardiac function of the patient and generally include a front/back pair of ECG sensing electrodes and a side/side pair of ECG sensing electrodes” (note at least Fig. 1B regarding such sensor located at, around a user’s center chest) and/or chest sensing device 130; “The connection pod 130 may also include other electronic circuitry, such as a motion sensor or accelerometer by which patient activity may be monitored”[0046]) (also Figs. 1A and 1B; as well as [0050]);
an output device (audible means via loudspeaker)([0047] and [0048]); and a processor configured (of control unit 120)(Figs. 1A and [0047]-[0049]) for
determining that the patient is experiencing a cardiac arrhythmia based on the received electrocardiogram signals (at least [0048] ”The at least one processor of the control unit 120 is configured to monitor the patient's medical condition, to perform medical data logging and storage, and to provide medical treatment to the patient in response to a detected medical condition, such as cardiac arrhythmia”)
providing, using the output device, an initial indication to the patient (at least [0047]”Where the control unit 120 determines that the patient is experiencing cardiac arrhythmia, the control unit 120 may issue an audible alarm via a loudspeaker (not shown) on the control unit 120 and/or the user interface pod 140 alerting the patient and any bystanders to the patient's medical condition.”);
processing information from the CPR sensor, providing, to the output device, information about the CPR therapy provided to the patient (processor of control unit 120)(Figs. 1A and 1B;[0047]- [0049]; e.g., “The user interface pod 140 typically includes one or more buttons by which the patient, or a bystander can communicate with the control unit 120, and a speaker by which the control unit 120 may communicate with the patient or the bystander.” ([0047] and “If the patient does not respond, the device may presume that the patient is unconscious, and proceed with the treatment sequence, culminating in the delivery of one or more defibrillating shocks to the body of the patient.” ([0048])).
Kaib is not specific regarding the waistband having attached thereto a flap, wherein the flap is capable of folding between (1) a first position in which the flap is positioned on the waistband and (2) a second position in which the flap is unfolded away from the waistband.
Kaib is not specific regarding the CPR sensor being coupled to the flap, wherein the CPR sensor is positioned at the center of the chest of the patient when the flap is in the second position.
Kaib is not specific regarding making a first determination, based on the received electrocardiogram signals, whether the cardiac arrhythmia is non-shockable by the wearable medical device, in response to the first determination resulting in an indication that the cardiac arrhythmia is non-shockable by the wearable medical device; providing, using the output device, instructions for a rescuer to unfold the flap from the first position to the second position, such that the flap is unfolded away from the waistband and positioned at the center of the chest of the patient; providing, using the output device, the indication that the CPR therapy should be administered to the patient, determining, based on the processed information, whether chest compressions are occurring and whether the CPR sensor is positioned at the center of the chest of the patient, in response to detecting an absence of chest compressions or improper positioning of the CPR sensor, providing, using the output device, feedback to assist in delivering effective CPR ,providing, using the output device, real-time guidance based on the processed information from the CPR sensor, the guidance comprising feedback related to at least one of a chest compressions rate or a chest compressions depth, providing, to the output device, the information about the CPR therapy provided to the patient, after detecting information from the CPR sensor indicative of the CPR therapy having been applied to the patient, making a second determination, based on the received electrocardiogram signals, that the cardiac arrhythmia is shockable by the wearable medical device, and in response to the second determination resulting in an indication that the cardiac arrhythmia is shockable by the wearable medical device, providing, using the output device, an indication that the treatment shock is about to be delivered to the patient.
With respect to “the waistband having attached thereto a flap, wherein the flap is capable of folding between (1) a first position in which the flap is positioned on the waistband and (2) a second position in which the flap is unfolded away from the waistband”, in a similar field of wearable medical devices, Pavelka discloses a flap 12 attached to waistband 11, of a garment 13 that is configure worn about a torso of a patient (Figs. 1 and 2; 2:24+); the flap is capable of folding between a first position in which the flap is positioned on the waistband (Fig. 1) and a second position in which the flap is unfolded away from the waistband (Fig. 2). position/folding between a first position (e.g. Fig. 1) and a second position at a patient’s chest (Fig. 2). Therefore, 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 to form Kaib’s waistband having attached thereto a flap, wherein the flap is capable of folding between (1) a first position in which the flap is positioned on the waistband and (2) a second position in which the flap is unfolded away from the waistband for the reason that a skilled artisan would have been motivated in using known mechanical means/attachment that facilitate holding, supporting, and storing medical devices with the worn garment, as suggested by Pavelka (e.g., 1:59+).
Pavelka is not specific regarding the medical device is a CPR sensor, however, Williams discloses a wearable garment includes a flap (garment panel 12 having a medical device coupled thereto, via pocket 13; (note at least 2:61+ that the medical device is “a cardiac monitor”, i.e., CPR sensor) positioned between first position (Fig. 4) and second position (Fig. 2). Therefore, 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 to form Kaib- Pavelka’s CPR sensor being coupled to the flap, wherein the CPR sensor is positioned at the center of the chest of the patient when the flap is in the second position for the reason that a skilled artisan would have been motivated by Williams’ suggestion that such garment structure is suitable to hold medical devices as needed (e.g., 1:28+ “The present invention provides a garment for accommodating medical devices comprising a garment body detachably coupled to a panel containing a concealed pocket for accommodating a medical device”)
With regard to determining, based on the processed information, whether chest compressions are occurring and whether the CPR (Centen in Figs. 1-2, and 11-14 in conjunction to [0040]-[0048], [0098]-[0128] and [0135]-[0157]; e.g., Figs. 13-14 [0142]-[0145]) and, in response to detecting an absence of chest compressions or improper positioning of the CPR sensor (Figs. 13 and 14; [0141]+; note steps 108-112), providing, using the output device, feedback to assist in delivering effective CPR(Figs. 13 and 14; [0141]+; note steps 108-112) ,providing, using the output device, real-time guidance based on the processed information from the CPR sensor (Figs. 13 and 14; [0141]+; note steps 108-112; also [0139]+), the guidance comprising feedback related to at least one of a rate or a depth of chest compressions (Figs. 13 and 14; [0141]+; note steps 108-112; e.g. step 110 and [0147]), providing, to the output device, information about the CPR therapy provided to the patient, after detecting information from the CPR sensor indicative of the CPR therapy having been applied to the patient (Figs. 13 and 14; [0141]+; note steps 108-112), making a second determination, based on the received electrocardiogram signals, whether the cardiac arrhythmia is shockable or non-shockable by the wearable medical device(Figs. 13 and 14; [0141]+; note steps 108-112; steps 126-130; par. [0150]+ if a defibration is require), and in response to the second determination resulting in an indication that the cardiac arrhythmia is shockable by the wearable medical device, providing, using the output device, an indication that the treatment shock is about to be delivered to the patient (Figs. 13 and 14; [0141]+; note steps 108-112; e.g. steps128-130). Therefore, 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 to form Kaib’s device to further determining, based on the processed information, whether chest compressions are occurring and whether the CPR sensor is positioned at the center of the chest of the patient, in response to detecting an absence of chest compressions or improper positioning of the CPR sensor, providing, using the output device, feedback to assist in delivering effective CPR ,providing, using the output device, real-time guidance based on the processed information from the CPR sensor, the guidance comprising feedback related to at least one of a rate or a depth of chest compressions, providing, to the output device, information about the CPR therapy provided to the patient, after detecting information from the CPR sensor indicative of the CPR therapy having been applied to the patient, making a second determination, based on the received electrocardiogram signals, whether the cardiac arrhythmia is non-shockable by the wearable medical device, and in response to the second determination resulting in an indication that the cardiac arrhythmia is shockable by the wearable medical device, providing, using the output device, an indication that the treatment shock is about to be delivered to the patient for the reason that a skilled artisan would have been motivated in using known technology while provide instruction for carrying out a proper CPR procedure for training, testing, and/or emergency situations. Such a device may be intuitive to use (Centen’s [0018]). Such data within the device of Kaib is much desired and enhance his data information regarding a patient medical situation.
In addition, with respect to sensor is positioned at the center of the chest of the patient, within the modified Kaib by at least the teachings of Williams, while the flap in the second position the flap (with the CPR sensor) would have been positioned at such location (e.g., Williams Fig. 2). In addition, note Centen’s [0158] ”The positions of the sensors may be modified by the CPR performer so as to suit the specific application, or the sensors may be interchangeable.” Thus, positioning the CPR sensor at the center of a patient’s chest would have been in such suitable position as suggested by Centen.
Also, with respect to the CPR sensor, the examiner construed Kaib’s accelerometer as the CPR sensor according to applicant’s original disclosure. In at least [0125] and [0153] it states “a garment configured to be worn about a torso of a patient and one or more sensors (e.g., including one or more accelerometers) for detecting characteristics of a cardiopulmonary resuscitation (CPR) therapy administered to the patient. For example, while a user is administering CPR to the patient, an accelerometer” and “The CPR sensor 140 may include one or more accelerometers that are configured to detect motion that occurs during the administration of CPR.” However, if there is any doubt regarding such interpretation, the examiner notes that the use of a CPR sensor, with a wearable, garment is well known as taught Centen (garment 2 with CPR sensing/performing means 4/16-18-20-22) (Figs. 2-2 and [0040]-[0066]; note also Figs. 2 and 12 in conjunction to [0089]-[0094] regarding a processing unit and [0098]-[0105] a feedback unit). Therefore, 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 to form Kaib’s with a CPR sensor for detecting a characteristic of a CPR therapy provided to the patient; and a processor configured for processing information from the CPR sensor and providing, to the output device, information about the CPR therapy provided to the patient as taught by Centen for the reason that a skilled artisan would have been motivated to include such CPR sensor (connected to a processor and output means) with a wearable garment as be desirable to provide an easy-to-use and inexpensive device to provide instruction for carrying out a proper CPR procedure for training, testing, and/or emergency situations. Such a device may be intuitive to use (Centen’s [0018]). In addition, consider, Kaib’s [0050] ”Although not shown, the wearable medical device 100 may include additional sensors, other than the ECG sensing electrodes 112, capable of monitoring the physiological condition or activity of the patient. For example, sensors capable of measuring blood pressure, heart rate, heart sounds, thoracic impedance, pulse oxygen level, respiration rate, and the activity level of the patient may also be provided.” Thus, such CPR sensor-to output device-to processor would have been such means for monitoring the physiological condition or activity of the patient, as suggested by Kaib.
With respect to providing, using the output device, instructions for a rescuer to unfold the flap from the first position to the second position, such that the flap is unfolded away from the waistband and positioned at the center of the chest of the patient, in a similar field of medical devices, Doherty discloses instruction to open case/lid/flap (equivalent to “unfold the flap from first-to-second position”) to remove CPR means to administer CPR procedure (Fig. 4 and [0022], in conjunction to Figs. 1 and 2; [0018]). Therefore, 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 to form Kaib’s providing, instructions for a rescuer to unfold the flap from the first position to the second position, such that the flap is unfolded away from for the reason that a skilled artisan would have been motivated in applying a known technique to a known device in a logical manner to instruct a user to remove the CPR means therefrom in order to follow instruction to administrated the proper CPR steps. With respect to such instruction are via the output means, it would have been obvious to provide the instruction via the output means (as taught by Kaib, e.g., [0047] and [0048] and/or Doherty’s Fig. 3, [0019]-[0021]) as using known means to clearly provide audible instructions for administrates the CPR in the require manner for training proposes as well as for saving life in real-time.
As per claim 92, with respect to wherein: the flap is attached to the waistband along a seam, note Pavelka’s Figs. 1-4 regarding flap/pouch 12 attached to waistband 11 (also, 3:4-10). Therefore, 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 to form Kaib’s the flap is attached to the waistband along a seam for similar reasons discussed above with respect to claim 91.
As per claim 93, with respect to wherein: when the flap is in the second position, the CPR sensor above a xiphoid process of the patient, within the modified Kaib-Pavelka the CPR sensor (as taught by Kaib) position within flap of Pavelka in the second position it would have been position at such location (e.g., Pavelka’s Fig. 2; also as shown in Williams’ Fig. 2). Therefore, 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 to form Kaib’s the flap is in the second position, the CPR sensor above a xiphoid process of the patient for similar reasons discussed above with respect to claim 91.
As per claim 94, with respect to wherein the characteristic of the CPR therapy comprises one or more of the chest compression depth or the chest compression rate, note Centen’s [0019], [0059], [0061], [0063]-[0067], [0069] and [0070]. Therefore, 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 to form Kaib’s wherein the characteristic of the CPR therapy comprises one or more of the chest compression depth or the chest compression rate for similar reasons discussed above with respect to claim 91.
As per claim 95, with respect to wherein the CPR sensor is coupled to flap using a hook-and-loop fastener, it 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 to form such connecting as using known mechanical means/ fastening to insure the CPR sensor firmly attached to the flap yet can be remove for replacement, maintenance and alike.
As per claim 96, with respect to wherein the indication that the CPR therapy should be administered to the patient is provided after determining that the CPR sensor is positioned at the center of the chest of the patient, note Kaib’s [0048] as well as Centen’s Figs. 2, 13 and 14; [0045], [0098]-[0105] regarding the use of a output device (i.e., feedback device) to instruct a user to use the device; note for example Fig. 13 and [0141]-[0149] as data receiving regarding patient’s cardiac condition to administer, or not, a CPR). With respect to the CPR sensor means, note the examiner discussion above with respect to claim 91. Therefore, 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 to form Kaib’s wherein the indication that the CPR therapy should be administered to the patient is provided after determining that the CPR sensor is positioned at the center of the chest of the patient for the reason that a skilled artisan would have been motivated in applying a known technique to a known device as a logical manner to determine, based upon the CPR sensor data, that position at a patient’s center of the chest (as the flap, with the CPR sensor at such position), to the correct procedure require for the CPR therapy.
As per claim 97, with respect to wherein: the garment further comprises a shoulder strap, note Kaib’s Figs. 1A and 1B ([0045]).
As per claim 99, with respect to wherein the flap pivots along the seam when the flaps moves between the first position and the second position, note Pavelka’s Fig. 1 position of flap 12 (i.e. first position) and pivots to a second position (Fig. 2) via/along the seam therebetween the flap and waistband 11 (see also 3:4-10). See also Williams’ Figs. 2 and 4 and 6:55-7:51 as the flap (panel 12) pivots along attachment zone 16. Therefore, 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 to form Kaib’s flap pivots along the seam when the flaps moves between the first position and the second position for similar reasons discussed above with respect to claim 91.
As per claim 103, with respect to wherein the CPR sensor is attached to the flap using a snap fastener, it 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 to use of known mechanical fasteners (e.g., snap fastener) to insure the CPR sensor firmly attached to the flap yet can be remove for replacement, maintenance and alike.
As per claim 106, with respect to wherein the waistband is positioned over a rib of the patient when the patient wears the garment, note Kaib’s Figs. 1A and 1B.
As per claim 107, with respect to wherein the characteristic of the CPR therapy comprises one or more of the chest compression depth or the chest compression rate, note Centen’s [0019], [0059], [0061], [0063]-[0067], [0069] and [0070]. Therefore, 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 to form Kaib’s wherein the characteristic of the CPR therapy comprises one or more of the chest compression depth or the chest compression rate for similar reasons discussed above with respect to claim 91.
As per claim 109, wherein the indication that the CPR therapy should be administered to the patient is provided after determining that the CPR sensor is positioned at the center of the chest of the patient, note Kaib’s [0048] as well as Centen’s Figs. 2, 13 and 14; [0045], [0098]-[0105] regarding the use of a output device (i.e., feedback device) to instruct a user to use the device; note for example Fig. 13 and [0141]-[0149] as data receiving regarding patient’s cardiac condition to administer, or not, a CPR. Therefore, 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 to form Kaib’s wherein the indication that the CPR therapy should be administered to the patient is provided after determining that the CPR sensor is positioned at the center of the chest of the patient for the reason that a skilled artisan would have been motivated in applying a known technique to a known device as a logical manner to determine, based upon the CPR sensor data position at a patient’s center of the chest (as the flap, with the CPR sensor as such position), to the correct procedure require for the CPR therapy.
As per claim 110, with respect to wherein the CPR sensor is configured to wirelessly communicate with the processor, note Centen’s [0053], [0090], [0093], [0099], [0106]-[0110], [0126], [0127], and [0137]; also note Kaib’s [0016], [0020], [0078], [0079], [0085], [0087] and [0088] regarding wireless communication. Therefore, 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 to form Kaib’s wherein the CPR sensor is configured to wirelessly communicate with the processor for similar reasons discussed above with respect to claim 91.
As per claim 111, since the claim’s limitations are very similar to claim 91, the examiner states that claim 111 is rejected over Kaib, Pavelka, Williams , Centen and Doherty for the same reasons discussed above with respect to claim 91. Since there is no apparent different structural and/or functional limitations of the device of claim 91 and the device of claim 111, it is important to note that such statement by the examiner is not merely to “ignore” the claim’s limitations; rather, the examiner attempts to simplify the above rejection, and not “paste and copy” similar limitations, thus to create unnecessary lengthy Office action. The examiner construed “a CPR sensor for detecting a characteristic of a CPR therapy provided to the patient, the CPR sensor being configured to be positioned at a center of a chest of the patient when the CPR therapy is provided to the patient” as the flap f a waistband with a flap moves between first and second positions to be place upon a user’s center of a chest (as taught by Pavelka) whereas the flap is provide with a CPR sensor (as taught by Williams).
As per claim 112, with respect to wherein, wherein the indication that the CPR therapy should be administered to the patient is provided after, determining that the CPR sensor is positioned at the center of the chest of the patient, note Kaib’s [0048] as well as Centen’s Figs. 2, 13 and 14; [0045], [0098]-[0105] regarding the use of a output device (i.e., feedback device) to instruct a user to use the device; note for example Fig. 13 and [0141]-[0149] as data receiving regarding patient’s cardiac condition to administer, or not, a CPR). Note, Centen’s Fig. 13 in conjunction [0141]+ as the use of his device and to determined shock or non-shock operation upon a user’s cardiac state , i.e., determining that the patient is experiencing bradycardia or asystole. Also, note Centen’s [0158] as the position of the sensor can be in any suitable location to reads/sense the cardiac condition of the patient. With respect to the CPR sensor means, note the examiner discussion above with respect to claim 91. Therefore, 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 to form Kaib’s wherein the indication that the CPR therapy should be administered to the patient is provided after, determining that the CPR sensor is positioned at the center of the chest of the patient for the reason that a skilled artisan would have been motivated in applying a known technique to a known device as a logical manner to determine, based upon the CPR sensor data, that position at a patient’s center of the chest (as the flap, with the CPR sensor at such position), to the correct procedure require for the CPR therapy.
As per claim 113, with respect wherein the garment includes: a shoulder strap.
note Kaib’s Figs. 1A and 1B ([0045]) regarding harness 110.
As per claim 114, with respect to wherein the garment has attached thereto a pocket that is positioned on the waistband of the garment, note Williams’s Figs. 1, 2, 3A and 4 regarding pocket 13 attached to garment 10. Therefore, 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 to form Kaib’s wherein the garment has attached thereto a pocket that is positioned on the waistband of the garment for the reason that a skilled artisan would have been motivated is applying a known technique to a known device to attached a pocket to a garment configure to hold the CPR sensor in a safe and concealed position yet allow easy access thereto to be remove and be place upon a user’s center chest for any require CPR therapy.
As per claim 115, with respect to wherein the pocket is configured to receive the CPR sensor when the flap is in the first position, note at least Williams’ Fig. 4 (regarding pocket 13) as well as Pavelka’s Fig. 1 as the flap in a first position (i.e., positioned on the waistband). Therefore, 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 to form Kaib’s wherein the pocket is configured to receive the CPR sensor when the flap is in the first position for the reason that a skilled artisan would have been motivated is applying a known technique to a known device to attached a pocket to a garment configure to hold the CPR sensor in a safe and concealed position yet allow easy access thereto to be remove and be place upon a user’s center chest for any require CPR therapy, while the pocket is attached to the waistband as a user wears the medical device.
As per claim 116, with respect to wherein the CPR sensor is positioned at the center of the chest of the patient when the flap is in the second position, note Williams’s Figs. 1 and 2 as the flap/pocket (with a c CPR sensor) in a second position, as well as Pavelka’s Fig. 2 as the flap in a second position (at user’s center of the chest). Therefore, 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 to form Kaib’s wherein the CPR sensor is positioned at the center of the chest of the patient when the flap is in the second position for the reason that a skilled artisan would have been motivated in applying a known technique to a known device as a logical manner to determine, based upon the CPR sensor data, that position at a patient’s center of the chest (as the flap, with the CPR sensor at such position), to the correct procedure require for the CPR therapy.
Response to Arguments
Applicant's arguments filed 4/1/2026 have been fully considered but they are partially not persuasive and are partially moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant stated that the office action did not point out to the limitations of claim 91, to “a processor configured for, among other things, "making a first determination, based on ... received electrocardiogram signals, that [a] cardiac arrhythmia is shockable or non- shockable by [a] wearable medical device". In response to the first determination resulting in an indication that the cardiac arrhythmia is non-shockable by the wearable medical device, the processor is further configured for, among other things, "providing, using [an] output device, instructions for a rescuer to unfold [a] flap from [a] first position to [a] second position, such that the flap is unfolded away from [a] waistband and positioned at [a] center of [a] chest of [a] patient", "after detecting information from [a] CPR sensor indicative of ... CPR therapy having been applied to the patient, making a second determination, based on the received electrocardiogram signals, that the cardiac arrhythmia is shockable by the wearable medical device", and "in response to the second determination resulting in an indication that the cardiac arrhythmia is shockable by the wearable medical device, providing, using the output device, an indication that [a] treatment shock is about to be delivered to the patient”, remarks pages 8 and 9.
With respect to a processor configured for, among other things, " ... received electrocardiogram signals, that [a] cardiac arrhythmia is shockable or non- shockable by [a] wearable medical device", as set forth above Kaib discloses a garment that includes a waistband configured to be worn about a torso of a patient (harness 110)(Figs. 1A and 1B; [0045]) a therapy electrode that is disposed in the garment and that is configured to apply a treatment shock to the torso of the patient (therapy electrodes 114a-114b)(Figs. 1A and 1B; [0046] and [0048]) an output device (audible means via loudspeaker)([0047] and [0048]); and a processor configured (of control unit 120)(Figs. 1A and [0047]-[0049]); with respect to making a first determination, based on In response to the first determination resulting in an indication that the cardiac arrhythmia is non-shockable by the wearable medical device, the processor is further configured for, among other things, "providing, using [an] output device, , "after detecting information from [a] CPR sensor indicative of ... CPR therapy having been applied to the patient, making a second determination, based on the received electrocardiogram signals, that the cardiac arrhythmia is shockable by the wearable medical device", and "in response to the second determination resulting in an indication that the cardiac arrhythmia is shockable by the wearable medical device, providing, using the output device, an indication that [a] treatment shock is about to be delivered to the patient, as set forth above such limitations are taught by Centen in Figs. 1-2, and 11-14 in conjunction to [0040]-[0048], [0098]-[0128] and [0135]-[0157]; e.g., Figs. 13-14 [0142]-[0145]) and, in response to detecting an absence of chest compressions or improper positioning of the CPR sensor (Figs. 13 and 14; [0141]+; note steps 108-112), providing, using the output device, feedback to assist in delivering effective CPR(Figs. 13 and 14; [0141]+; note steps 108-112; again Figs. 13 and 14; [0141]+; note steps 108-112; also [0139]+), the guidance comprising feedback related to at least one of a rate or a depth of chest compressions (Figs. 13 and 14; [0141]+; note steps 108-112; e.g. step 110 and [0147]).
With respect to “instructions for a rescuer to unfold [a] flap from [a] first position to [a] second position, such that the flap is unfolded away from [a] waistband and positioned at [a] center of [a] chest of [a] patient", such new limitations as instructing a user/rescuer to manipulate the flap (e.g., a flap as taught by Pavelka and Williams) to be unfolded from first position to a second position, are taught by the newly cited reference to Doherty as set forth above. Within the modified Kaib such instruction would have been to positioned the flap at a center of a chest of a patient (e.g., note Williams’s Figs. 1 and 2 as the flap/pocket (with a c CPR sensor) in a second position, as well as Pavelka’s Fig. 2 as the flap in a second position (at user’s center of the chest).
With respect to claim 111, as set forth above the claim amended to recite similar limitations as amended claim 91, and the examiner maintains his position that the prior art teaches and suggested all the limitations as set forth 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 AMIR ARIE KLAYMAN whose telephone number is (571)270-7131. The examiner can normally be reached Monday-Friday; 7:00 AM-4:30 PM.
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/A.A.K/Examiner, Art Unit 3711 4/28/2026
/JOHN E SIMMS JR/Primary Examiner, Art Unit 3711
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