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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/26/2024 has been placed in record and considered by the examiner.
Claim Objections
Claims 2 – 13 are objected to because of the following informalities:
Regarding claim 2, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 3, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 4, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 5, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 6, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 7, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 8, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 9, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 10, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 11, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 12, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Regarding claim 13, line 1 states “Front-end communication unit” it should state “The front-end communication unit” instead.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. 101 because giving its broadest and reasonable interpretation of a claim drawn to a computer-readable storage medium typically covers form of non-transitory tangible media and transitory propagating signal per se.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1 and 8 – 15 are rejected under 35 U.S.C. 103 as being unpatentable over Worrell et al. (US 2014/0018779 A1 as filed in IDS) in view of Ohlander et al. (US 2009/0177145 A1).
Regarding claim 1, Worrell discloses a front-end communication unit for an implant communication system (Patient Care Unit, Fig. 7, element 102/103) comprising: a communication interface (wireless communication device, Fig. 7, element 250) configured to read out data from external wireless instruments (the patient care device is capable of obtaining medical data from a variety of external wireless instruments; Page 7, Paragraphs 0121 – 0122), and a control unit (Processing Device; Fig. 7, element 230) communicatively connected to the communication interface (the processing device 230 is connected to the wireless communication device 250), the control unit being configured to transfer the data read out by the communication interface to a back-end communication unit (the processing device is capable of using different wireless communication devices to transfer the data obtained by the patient care unit; Page 6, Paragraph 0114), wherein the front-end communication unit is configured to receive audio input and provide audio output (the patient care unit includes audio codec and amplifier device( Fig. 7, elements 260 and 264); Page 6, Paragraphs 0115 – 0116), and wherein the communication interface comprises an LTE and/or 5G interface, configured to receive incoming voice calls and to initiate outgoing voice calls (the patient care unit also includes LTE modem (Fig. 7, element 252) for cellular communication; Page 6, Paragraph 0114 and Page 13, Paragraphs 0197 – 0200).
However, Worrell does not specifically disclose a communication interface configured to read out data from an implantable medical device.
In an analogous art, Ohlander discloses a communication interface configured to read out data from an implantable medical device (an implantable medical device (Fig. 3, element 20) is implanted in a patient (Fig. 3, element 40) and the implantable medical device transfers its data to one or more extracorporeal devices, i.e. Home Monitoring Unit, Cellular Device or a Remote Monitoring Device; Page 6, Paragraph 0059).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the technique of Ohlander to Worrell to provide an effective patient monitoring system to measure and collect patient status for therapeutic purposes over a long term period to improve patient care (Ohlander: Page 2, Paragraphs 0018 – 0022).
Regarding claim 8, the combination of Worrell and Ohlander, specifically Worrell discloses wherein the front-end communication unit is configured, upon a change of information displayed on a screen of the front-end communication unit, to generate an audio output corresponding to the information displayed on a screen of the front-end communication unit (the patient care unit includes a display and speaker that generate audible sounds or instructions provided by the patient care device; Page 6, Paragraphs 0111 – 0115).
Regarding claim 9, the combination of Worrell and Ohlander, specifically Worrell discloses wherein the front-end communication unit is configured, upon a status change of the front-end communication unit, to generate an audio output corresponding to the status change of the front-end communication unit (reminders and alerts can be provided by the patient care unit such as audible or visible alarms; Page 13, Paragraphs 195).
Regarding claim 10, the combination of Worrell and Ohlander, specifically Worrell discloses wherein the front-end communication unit is configured, when a user interaction with the front-end communication unit is required, to generate an audio output corresponding to the required user interaction with the front-end communication unit (reminders and alerts can be provided by the patient care unit such as audible or visible alarms; Page 13, Paragraphs 195).
Regarding claim 11, the combination of Worrell and Ohlander, specifically Worrell discloses wherein the front-end communication unit is configured to receive and process audio input whenever there is no audio output (the microphone operates to detect sounds generated by the patient; Page 6, Paragraph 0115).
Regarding claim 12, the combination of Worrell and Ohlander, specifically Worrell discloses wherein in case of an operating error and/or technical malfunction of the front-end communication unit, the front-end communication unit is configured to call a service center of a healthcare provider (during the validation process the user will be presented with some options and even if the user makes a mistake, he will be given an opportunity to either call or cancel in reaching a healthcare provider; Page 14, Paragraph 0212).
Regarding claim 13, the combination of Worrell and Ohlander, specifically Worrell discloses wherein the front-end communication unit is configured to automatically transmit a session ID to a service center of a healthcare provider and to initiate a voice call to a field representative upon completion of a predetermined workflow of the front-end communication unit (whenever there is either a video or voice call between the patient care unit and server or healthcare professional, it would have been obvious to one of ordinary skill in the art to recognize that a session ID (not shown) is always included during the process of establishing communication; Page 7, Paragraphs 0125 – 0130).
Regarding claim 14, the claim is interpreted and rejected for the same reason as set forth in claim 1.
Regarding claim 15, the claim is interpreted and rejected for the same reason as set forth in claim 14.
Claims 2 – 7 are rejected under 35 U.S.C. 103 as being unpatentable over Worrell and Ohlander and further in view of Patnaikuni et al. (US 12,097,374 B2).
Regarding claim 2, the combination of Worrell and Ohlander does not specifically disclose wherein the front-end communication unit comprises an audio processing unit configured to process the audio input by means of a voice recognition algorithm, wherein the audio input is configured to process user commands and/or user questions directed to the front-end communication unit.
In an analogous art, Patnaikuni discloses wherein the front-end communication unit comprises an audio processing unit configured to process the audio input by means of a voice recognition algorithm (client device 120 (i.e. a laptop computer, a tablet computer, a smart phone, etc.) includes an audio processing unit; Col. 3, lines 39 – 55), wherein the audio input is configured to process user commands and/or user questions directed to the front-end communication unit (the user interacts with the client device using interaction program 200 which identifies a voice command of a user; Fig. 2 and Col. 6, lines 7 – 53).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the technique of Patnaikuni to the combination of Worrell and Ohlander in order to make use of voice interaction to monitor health related issues in a more meaningful and natural way that will ultimately benefit the user having the implanted device (Patnaikuni: Col. 2, lines 23 – 45).
Regarding claim 3, the combination of Worrell, Ohlander and Patnaikuni, specifically Patnaikuni discloses wherein the audio processing unit is configured, whenever a user command and/or user question directed to the front-end communication unit is recognized by the voice recognition algorithm, to perform a predefined function associated with the user command and/or user question (Col. 6, lines 25 – 53).
Regarding claim 4, the combination of Worrell, Ohlander and Patnaikuni, specifically Patnaikuni discloses wherein the audio output comprises audible status information of the front-end communication unit and/or the implantable medical device, and wherein the audio output further comprises audible instructions directed to a user of the front-end communication unit (the user interacts with the client device 120 which can be a laptop computer, a tablet computer or a smart phone and those devices include a speaker that can provide audio feedback to the user when interacting with them via voice command; Col. 3, lines 39 – 55 and Col. 6, lines 25 – 53).
Regarding claim 5, Worrell discloses wherein the communication interface further comprises a mobile interface different from the LTE and/or 5G-interface, configured to receive incoming voice calls and to initiate outgoing voice calls (as shown in Fig. 40, the patient care unit 102 includes two tups of mobile interface, one for audio and another one for data and video; Page 13, Paragraph 0197).
Regarding claim 6, the combination of Worrell, Ohlander and Patnaikuni, specifically Ohlander discloses wherein the communication interface comprises a Bluetooth-interface configured to connect to the implantable medical device and/or to connect to a mobile communication device, in particular a smartphone (implantable medical device communicates with a smartphone via RF communication unit 37 using spread spectrum frequency hopping (i.e. Bluetooth); Page 6, Paragraph 0059).
Regarding claim 7, the combination of Worrell, Ohlander and Patnaikuni, specifically Ohlander discloses wherein the communication interface comprises a WiFi-interface configured to transmit the data read out from the implantable medical device to a back-end communication unit of the implant communication system (implantable medical device communicates with a smartphone via RF communication unit 37 using WLAN; Page 6, Paragraph 0059).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hatlestad et al. (US 2011/0251506 A1) discloses an advanced patient management with composite parameter indices
McDermott (US 2008/0167531 A1) discloses a system and method to monitor battery status in an implantable medical device
Zhang et al. (US 2006/0116594 A1) discloses a method and apparatus for arrhythmia classification using atrial signal mapping
Bardy (US 2004/0044274 A1) discloses a system and method for providing feedback to an individual patient for automated remote patient care
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Un C Cho whose telephone number is (571)272-7919. The examiner can normally be reached 9AM-5PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/UN C CHO/Supervisory Patent Examiner, Art Unit 2413
Prosecution Insights