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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because: reference characters “50” and “52” appear to be used to refer to “in-link” / “out-link” communications/signal pathways in Figs. 1, 3 [see ¶¶0068, 0071], structural elements of capsule 17 in Fig. 2C, and data in Fig. 19 [reference character 50 only]; reference character “54” appears to be used to refer to a user interface [mobile device] and the act of the user interface performing wireless communication in Fig. 3; reference character “320” appears to be used to refer to an electromagnetic transmitter block / out-link TX carrier [see ¶0134] and a frequency in Fig. 14; reference character “86” appears to be used to refer to two different elongated pads in Fig. 21A; reference character “46” appears to be used to refer to the capsule and cap in Fig. 22.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “system 260A” in ¶¶0078-0080.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference characters “51” in Fig. 2C; “262” in Fig. 6C; “R3” in Fig. 9.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 10 and 13-15 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 10 recites the limitation “the timing of the peaks in the ECG signal” [line 2], which lacks antecedent basis, as claims 2 and 10 fail to previously define any timing of any peaks of any ECG signal, and further renders claim 13 indefinite, as it is not clear whether claim 13 is meant to define “a timing of peaks of an ECG signal” or whether claim 13 is meant to be dependent from any of claims 7-9, which define an ECG signal, such that claim 10 would refer to a timing of peaks of the ECG signal as defined by any of claims 7-9. For examination purposes, the Examiner has interpreted the indefinite limitation to read “[[the]] a timing of [[the]] peaks in [[the]] an ECG signal”.
Claim 13 recites the limitation “the ECG” [line 2], which lacks antecedent basis, as claims 2 and 13 fail to previously define “an ECG”, and further renders claim 13 indefinite, as it is unclear whether claim 13 is meant to recite “an ECG” to define a new element of an ECG signal or whether claim 13 is meant to be dependent from any of claims 7-10 which define an ECG / ECG signal. For examination purposes, the Examiner has interpreted the indefinite limitation to read “[[the]] an ECG”.
Claim 14 recites the limitation “the peak of QRS” [line 2], which lacks antecedent basis, as claims 2 and 14 fail to previously define “a peak of QRS”, and further renders claim 14 indefinite, as it is not clear whether claim 14 is meant to define “a peak of QRS” or whether claim 14 is meant to be dependent from at least claim 10, which is considered to define QRS amplitudes. For examination purposes, the Examiner has interpreted the indefinite limitation to read “[[the]] a peak of QRS”.
Claim 15 recites the limitation “the data points representing a pulse of ECG” [line 2], which lacks antecedent basis, as claims 2 and 15 fail to previously define any data points representing a pulse of ECG, and further renders claim 15 indefinite, as it is not clear whether claim 15 is meant to define the physiological signals as comprising “data points representing a pulse of ECG” or whether claim 15 is meant to be dependent from any of claims 7-10 and 13, which define the physiologic signals as being an ECG / ECG signal / feature of [an] ECG [see corresponding § 112(b) rejection of claims 10 and 13 above]. For examination purposes, the Examiner has interpreted the indefinite limitation to define the physiologic signals as comprising data points representing a pulse of ECG.
Claim Rejections - 35 USC § 101
Examiner’s Note Regarding § 101 Analysis: The Examiner notes that claim(s) 2 recites a judicial exception [“wherein the physiologic signals received by the reader can be compared to a previously collected physiologic signal to determine whether the signals received by the reader are from the same patient of the previously collected physiologic signal”] at Step 2A Prong 1, which is considered to be an abstract idea that may be performed in the mind or by hand by merely observing at least a limited amount of known and / or collected data and drawing mental conclusions therefrom, under no particular time constraints. However, the Examiner further notes that claim(s) 2 recites limitations directed towards a “medication device having an electronic transmission capability that is configured to transmit data wirelessly via an antenna, wherein the data includes physiologic signals corresponding to measurement of one or more physiological parameters of a patient who ingested the medication device”, “a power source coupled to the medication device and configured to harvest energy when at least one electrode of the power source chemically interacts with a patient’s stomach acid…”, and “a reader…” that is / are considered to integrate the judicial exception into a practical application at Step 2A Prong 2 and allow the invention to amount to significantly more than the judicial exception at Step 2B.
Claim Rejections - 35 USC § 102
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.
Claim(s) 2-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Reilly (US-20110009715-A1), which incorporates Robertson (PCT/US2008/52845 corresponding to US-20100185055-A1) by reference.
Regarding claim 2, O’Reilly, which incorporates Robertson by reference, teaches
An electronic medication adherence system comprising:
a medication device having an electronic transmission capability that is configured to transmit data wirelessly via an antenna [The ingestible device may comprise, for example, a microchip. The microchip may be independently deployed. The microchip may also be attached to, embedded in, or otherwise integrated with a medication, e.g., a pill (refer to IEM system, infra) (O’Reilly ¶0125); The ingestible devices 300a gather/collect/generate IEM data via various methods, e.g., ingestion timing, contact with alimentary system substances, sampling, etc. Further, various ingestible event marker data source devices 300 communicate the IEM data via various methods, e.g., wireless methods (O’Reilly ¶0134); The signal generation component may include a distinct transmitter component that serves to transmit the generated signal to a remote receiver, which may be internal or external to the patient, as reviewed in greater detail below. The transmitter component, when present, may take a number of different configurations, e.g., depending on the type of signal that is generated and is to be emitted… In certain embodiments, the transmitter component is made up of one or more wires, e.g., in the form of antenna(e) (Robertson ¶0075), wherein O’Reilly incorporates the IEM system of an IEM and a signal receiver as taught by Robertson by reference (see O’Reilly ¶¶0134-0136)], wherein the data includes physiologic signals corresponding to measurement of one or more physiological parameters of a patient who ingested the medication device [the IEM data may be associated with a unique identifier, e.g., heart rate variability, breathing rate, and/or heart rate (ECG) patterns associated with a particular individual (O’Reilly ¶0115); The IEM data associated with the IEM system include personal data, e.g., physiologic data generated by the IEM… IEM data, e.g., derived metrics and/or combined metrics aggregated with various physiologic data such as time of ingestion data combined with data identifying the ingested substance and physiologic data such as ECG data, temperature, etc. (O’Reilly ¶0137)];
a power source coupled to the medication device and configured to harvest energy when at least one electrode of the power source chemically interacts with a patient's stomach acid, wherein the power source is configured to store the harvested energy and deliver the energy to power transmission [In certain of these embodiments, the battery power source may be viewed as a power source that exploits electrochemical reaction in an ionic solution such as gastric fluid, blood, or other bodily fluids and some tissues. FIG. 1 provides a diagrammatic representation of an identifier according to an embodiment of the invention. First and second electrode materials (32 and 33) are in an ionic solution 39 (e.g., stomach fluid). This configuration creates a low voltage (V-) and a high voltage (V+) as applied to an electronic circuit 40. The two outputs of that electronic circuit 40 are E0 41 and E1 42, which are the signal-transmission electrodes (Robertson ¶0058), wherein O’Reilly incorporates the IEM system of an IEM and a signal receiver as taught by Robertson by reference (see O’Reilly ¶¶0134-0136)]; and
a reader for receiving the data indicating the presence of the medication device in a patient's body or digestive tract and the physiologic signals corresponding to measurement of one or more physiological parameters of the patient who ingested the medication device [The IEM may be associated, for example, with a receiver, i.e., a device capable of receiving the IEM data on ingestion and further capable of measuring additional IEM data on response to the ingestion event(s) (O’Reilly ¶0079); The IEM data receivers 300b include devices capable of receipt of IEM data 200. Receipt may be, for example, via wireless or wired channels, etc. The IEM data receiver 300b may also transmit or otherwise forward data. In various aspects, the IEM data receiver 300b may perform, facilitate, or enable various other functionalities related to the IEM data 200 and/or other data (O’Reilly ¶0140)];
wherein the physiologic signals received by the reader can be compared to a previously collected physiologic signal to determine whether the signals received by the reader are from the same patient of the previously collected physiologic signal [the IEM data may be associated with a unique identifier, e.g., sample data reflective of physiologic patterns associated with a particular individual such as heart rate variability, breathing rate, and/or heart rate (ECG) patterns. For example, a portion or all of the IEM data may be compared with a unique identifier generated by or stored on the receiver (O’Reilly ¶0082); When the receiver is affixed or otherwise associated with an individual, programming logic associated with the receiver may receive actual data samples of the individual, e.g., from data sources such as heart devices, etc. The receiver may communicate the actual data samples received from the data sources and the unique identifier(s) received from the IEM(s) to a computer-related device, e.g., a server, which may compare the actual data samples of the individual with the unique identifier to verify that the medication was actually ingested by the particular patient for whom it was prescribed (O’Reilly ¶0118)].
Regarding claim 3, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the reader is in wireless communication with the medication device and configured to receive the data [O’Reilly ¶0140].
Regarding claim 4, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the data is encoded for transmission [The digital transmission aspects include on/off keying, frequency-shift keying, amplitude-shift keying, phase-shift keying, e.g.,… higher order and differential encoded (O’Reilly ¶0161)].
Regarding claim 5, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the power source comprises a pair of electrodes [Robertson ¶0058, wherein O’Reilly incorporates the IEM system of an IEM and a signal receiver as taught by Robertson by reference (see O’Reilly ¶¶0134-0136)].
Regarding claim 6, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the medication device comprises a sensor configured to detect one or more physiological parameters [O’Reilly ¶¶0134, 0137].
Regarding claim 7, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the physiologic signals are from measurement of the patient's ECG [O’Reilly ¶¶0115, 0137].
Regarding claim 8, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the physiologic signals are a characteristic of the patient's ECG signal [O’Reilly ¶¶0115, 0137].
Regarding claim 9, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the physiologic signals correspond to an ECG signal [O’Reilly ¶¶0115, 0137].
Regarding claim 10, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the physiologic signals comprise signals corresponding to the timing of the peaks in the ECG signal [O’Reilly ¶¶0115, 0137], heart rate [O’Reilly ¶0115], ratio of P to QRS or T to QRS amplitudes, duration of P-R or R-T timing or QRS duration [O’Reilly ¶¶0115, 0137].
Regarding claim 11, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the physiologic signals are signals corresponding to breath rate [O’Reilly ¶0115], muscle activity, acoustic information [With respect to IEM data processing associated with physiologic parameter metrics, aspects include, for example,… sound,… derived electromyography (EMG) (O’Reilly ¶0176)], blood flow [IEM data processing related to impedance includes, for example, respiration, fluid status, Galvanic skin response, blood flow, etc. (O’Reilly ¶0178)], pulse oximetry [IEM data processing related to optical includes, for example, hematocrit, O2 saturation, pulse oximetry, etc. (O’Reilly ¶0180)], or body movement [IEM data processing related to acceleration, includes, for example, direct acceleration, which includes total activity and derived acceleration, which further includes activity type (O’Reilly ¶0179)].
Regarding claim 12, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the previously collected physiologic signal of the patient is measured by the reader [In addition to receiving a signal from an identifier of an ingestible event marker, the signal receiver may further include one or more distinct physiological parameter sensing abilities. By physiological parameter sensing ability is meant a capability of sensing a physiological parameter or biomarker, such as, but not limited to: heart rate, respiration rate, temperature, pressure, chemical composition of fluid, e.g., analyte detection in blood, fluid state, blood flow rate, accelerometer motion data, IEGM (intra cardiac electrogram) data, etc. (Robertson ¶0151), wherein O’Reilly incorporates the IEM system of an IEM and a signal receiver as taught by Robertson by reference (see O’Reilly ¶¶0134-0136)].
Regarding claim 13, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the physiologic signals are timed relative to a feature of the ECG [O’Reilly ¶¶0115, 0137].
Regarding claim 14, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the physiologic signals are timed relative to the peak of QRS [O’Reilly ¶¶0115, 0137, wherein assessing ECG patterns is considered to be defined by QRS amplitudes].
Regarding claim 15, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein principal component analysis is used for feature extraction from the data points representing a pulse of ECG [IEM data processing related to EKGs includes, for example, compression data, e.g., wavelet and ICA/PCA (O’Reilly ¶0177)].
Regarding claim 16, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein multiple physiologic signals are used simultaneously [O’Reilly ¶¶0115, 0137].
Regarding claim 17, O’Reilly, which incorporates Robertson by reference, teaches
The system of claim 2, wherein the physiologic signals received by the reader can be continuously compared to a previously collected physiologic signal of the patient to determine whether the person wearing the reader is the same as the person who provided the previously collected physiologic signal [One example of processing is analysis of the IEM data 200 to determine degree of patient adherence to medication regimen, i.e., determine if the patient ingested the prescribed medication in the right dosage at the prescribed time interval(s) (O’Reilly ¶0267), wherein assessing compliance of the patient to ingest the IEM at certain time intervals, as assessed by the reader (O’Reilly ¶0079), is considered to read on the reader “continuously” comparing received signals to a previously collected physiologic signal (O’Reilly ¶¶0082, 0118)].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791