DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
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).
Claim 1-5, 28-31 and 39 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2010/0191136 A1 to Wolford in view of US 5,277,193 A to Takishima et al. (“Takishima”) and further in view of US 7,809,442 B2 to Bolea et al. (“Bolea ‘442”).
As to claim 1, Wolford discloses a system for detecting and treating sleep apnea, said system comprising:
one or more physiological sensors configured to generate a signal (see Fig 3, element 115);
a sensor processing unit comprising a processor and coupled with the one or more physiological sensors, the sensor processing unit configured to process the signal of the one or more physiological sensors and to extract information related to an apneic or snoring state of a subject to obtain a signal relating to sleep-disordered breathing (see [0023] – “Referring to FIG. 2, the main control unit 130 includes a controller (such a microprocessor 132) for implementing and controlling software algorithms designed for detecting the data signals from the sensors 115 (“detecting circuit 134”), judging and comparing the data signals to a given criteria for calculating vital statistics and determining an apnea state (“judging circuit 136”), and for outputting control signals to the vibration devices 120 upon detecting an apnea state (“wireless/wired signal outputting circuit 138”).”);
the sensor processing unit including a communications module (see Fig 2, element 138); and
the system further comprising a therapeutic device configured to communicate with the communications module (see [0026] – “An example wireless configuration can be a wireless LAN option to permit the main control unit 130 to be moved about the patient room or to other rooms in the NICU or ICU. Using 802.11b technology, the main control unit 130 can be designed to be integrated into an existing wireless network. As shown in FIG. 3, one or more of the gel mattress 110, position sensors 115, vibration devices 120 and main control unit 130 can be configured with tiny transceivers including associated radio and microprocessor components, such that signal communication between components is wireless.”) and comprising a bio-feedback mechanism configured to stimulate an anatomical region of the subject for an apnea or snoring event, wherein the therapeutic device is configured to stimulate a nerve or muscle in the region of a neck that is associated with breathing (see [0033] – “In an example, given algorithm functions under controller 132 can generate specific control signals to be sent by the wireless/wired outputting circuit 138 so that the vibration devices 120 are energized in a particular sequence, such as starting at the feet and moving upward toward the chest and neck area of the patient.”).
Wolford fails to disclose wherein the therapeutic device comprises electrodes and is configured for electrical stimulation to produce tetanic contraction of a genioglossus muscle.
In a similar invention, Takishima teaches an apnea therapeutic device having a bio-feedback mechanism comprising electrodes and is configured for electrical stimulation to produce tetanic contraction of a genioglossus muscle (see col 1, lns 43-48 and col 2, ln 1-11 – “To attain the above object of the present invention, there is provided…an electric stimulating wave generating circuit which, when apnea has continued for 5 to 10 seconds after its detection by said detection signal generator, starts to operate and generates electric stimulating waves having a frequency of 40 to 100 Hz and a pulse peak value of 1 to 50 V; and a stimulating circuit composed of genioglossus stimulators which are supplied with the output of the said electric stimulating wave generating circuit... The inventors of this application have clarified by experiments that the upper airway can be recovered from obstruction which causes apnea stimulating the genioglossus, which is one of the dilator muscles of the upper airway, with pulses of a frequency of 40 to 150 Hz, a peak value of 1 to 50 volts and rise-up time constant of 0.2 seconds or more, and that control of the start and stop of the electric stimulation with apnea detection signals would make it possible to automatically take measures to deal with apnea even at night when it is particularly difficult to find a fit of apnea.”).
It would have been obvious to one of ordinary skill in the art to modify the apnea and therapeutic device of Wolford to further include the electrical stimulation of Takishima in order to provide the predictable result of preventing sleep apnea.
Neither Wolford nor Takishima discloses wherein the electrical stimulation progressively increases according to a plurality of increases of an amplitude parameter.
However, in a similar device, Bolea ‘442 discloses a similar stimulation for a similar purpose and further teaches wherein the electrical stimulation progressively increases according to a plurality of increases of an amplitude parameter (see col 40, ln 33-46). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the stimulation provided by Takishima to include the progressively increased stimulation provided by the Bolea ‘442 reference in order to achieve the predictable result that is a system that will wake the user during sleep less frequently and that “learns” from past stimulation paradigms and results thereof.
As to claim 2, Takishima further discloses wherein the therapeutic device is configured to noninvasively stimulate the nerve or muscle (see treatment of claim 1).
As to claim 3, Takishima further discloses wherein the therapeutic device is configured to stimulate a hypoglossal nerve region (see Fig 5).
As to claim 4, Wolford further discloses wherein the therapeutic device further comprises a vibratory stimulation element (see [0033] and treatment of claim 1).
As to claim 5, Wolford further discloses wherein the therapeutic device is further configured to provide a vibratory stimulus of progressively increasing pulse width and pulse repetition rate ([0033] – the device is capable of delivering such stimulation).
Claim 28 is rejected for the reasons set forth in the treatment of claim 1.
Claim 29 is rejected for the reasons set forth in the treatment of claim 2.
Claim 30 is rejected for the reasons set forth in the treatment of claim 3.
Claim 31 is rejected for the reasons set forth in the treatment of claim 4.
As to claim 39, Takishima further discloses wherein the therapeutic device is configured to invasively and directly stimulate the hypoglossal nerve, wherein the therapeutic device is configured for electrical stimulation with a stimulation frequency, amplitude and pulse duration, and wherein the stimulation frequency is in a range between 50 to 100 Hertz (see treatment of claim 1).
As to claims 42-43, Bolea ‘442 indicates that stimulation is progressively increased and points to amplitude, pulse width, and frequency as being the types of parameters that are adjusted (see col 40, ln 46-49).
Claims 6 and 33 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wolford in view of Takishima and further in view of Bolea ‘442 and further in view of US 2006/0145878 A1 to Lehrman et al. (“Lehrman”).
As to claims 6 and 33, Wolford fails to disclose wherein the therapeutic device comprises a neck patch constructed from biocompatible materials. However, Lehrman discloses such a neck patch (see Fig 4). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the treatment device of Wolford to use the neck patch of Lehrman in order to more particularly apply treatment to an area of interest as taught by Lehrman. While a small difference may be said to be the disclosure of a band by Lehrman instead of the patch as claimed, those having ordinary skill in the art commonly substituted bands for patches and vice versa, as needed, to maintain the balance of comfort and fixation of the device about the user.
Claims 7-13, 27, and 34-35 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wolford in view of Takishima and further in view of Bolea ‘442 and further in view of US 2010/0152600 A1 to Droitcour et al. (“Droitcour”).
As to claims 7-13, 27, and 34-35, Wolford fails to disclose
wherein at least one physiological sensor of the one or more physiological sensors is radar-based and configured to measure physiological motion and derive respiratory motion from the measured physiological motion;
wherein at least one physiological sensor of the one or more physiological sensors is radar based and further configured to detect non-respiratory motion;
wherein the one or more physiological sensors includes a sensor configured to:
generate electromagnetic radiation from a source of radiation, wherein the frequency of the electromagnetic radiation is in the radio frequency range, transmit the electromagnetic radiation towards a subject using one or more transmitters, receive a radiation scattered at least by the subject using one or more receivers, extract a Doppler shifted signal from the scattered radiation, and transform the Doppler shifted signal to a digitized motion signal;
wherein the digitized motion signal comprises one or more frames, wherein the one or more frames include time sampled quadrature values of the digitized motion signal, and wherein the one or more physiological sensors and the sensor processing unit are configured to:
demodulate the one or more frames using a demodulation algorithm executed by one or more processors to isolate a signal corresponding to a physiological movement of the subject or part of the subject, analyze the signal to obtain information corresponding to a non-cardiopulmonary motion or other signal interference, and process the signal to obtain information corresponding to the physiological movement of the subject or part of the subject, substantially separate from the non-cardiopulmonary motion or other signal interference;
wherein at least one physiological sensor of the one or more physiological sensors is a radar based sensor;
wherein the at least one physiological sensor is further configured to detect a heart rate of the subject, the heart rate being used to confirm an apnea indicated by other measurements;
wherein the at least one physiological sensor comprises multiple antenna hardware to track movement of subject while sleeping;
wherein at least one physiological sensor of the one or more physiological sensors is a non-contact physiological motion sensor.
However, in a similar device for measuring respiration, Droitcour discloses
wherein at least one physiological sensor of the one or more physiological sensors is radar-based and configured to measure physiological motion and derive respiratory motion from the measured physiological motion (see [0031] -- “One embodiment includes a system for sensing a physiological motion including one or more antennas configured to transmit electromagnetic radiation, one or more antennas configured to receive electromagnetic radiation, at least one processor configured to extract information related to cardiopulmonary motion by executing at least one of a demodulation algorithm, a non-cardiopulmonary motion detection algorithm, a rate estimation algorithm, a paradoxical breathing algorithm and a direction of arrival algorithm, and a communications system configured to communicate with an output device, the output device configured to output information related to the cardiopulmonary motion. In one embodiment, a vital signs monitor is configured to monitor at least one of a respiration rate, a heart rate, a depth of breath, respiratory waveform, heart waveform, tidal volume activity and degree of asynchronous breathing in one or more subjects. In one embodiment, an apnea detection system is configured to monitor at least one of a respiration rate, a heart rate, a depth of breath, tidal volume and paradoxical breathing and the presence or absence of breathing in one or more subjects.”;
wherein at least one physiological sensor of the one or more physiological sensors is radar based and further configured to detect non-respiratory motion (see above, heart rate);
wherein the one or more physiological sensors includes a sensor configured to:
generate electromagnetic radiation from a source of radiation, wherein the frequency of the electromagnetic radiation is in the radio frequency range (see [0031]), transmit the electromagnetic radiation towards a subject using one or more transmitters (see [0031]), receive a radiation scattered at least by the subject using one or more receivers, extract a Doppler shifted signal from the scattered radiation, and transform the Doppler shifted signal to a digitized motion signal (see [0042]-[0054]);
wherein the digitized motion signal comprises one or more frames, wherein the one or more frames include time sampled quadrature values of the digitized motion signal (see [0036]), and wherein the one or more physiological sensors and the sensor processing unit are configured to:
demodulate the one or more frames using a demodulation algorithm executed by one or more processors to isolate a signal corresponding to a physiological movement of the subject or part of the subject (see [0042]), analyze the signal to obtain information corresponding to a non-cardiopulmonary motion or other signal interference, and process the signal to obtain information corresponding to the physiological movement of the subject or part of the subject, substantially separate from the non-cardiopulmonary motion or other signal interference ([0036]);
wherein at least one physiological sensor of the one or more physiological sensors is a radar based sensor (see above);
wherein the at least one physiological sensor is further configured to detect a heart rate of the subject, the heart rate being used to confirm an apnea indicated by other measurements (see [0193]);
wherein the at least one physiological sensor comprises multiple antenna hardware to track movement of subject while sleeping (see [0240);
wherein at least one physiological sensor of the one or more physiological sensors is a non-contact physiological motion sensor (see [0031]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the breathing sensor of Wolford for the non-contact physiological sensor of Droitcour to provide the predictable result of making it easier for the patient to sleep while also monitoring heart rate in conjunction with respiration.
Claim 32 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wolford in view of Takishima and further in view of Bolea ‘442 and further in view of US 2010/0174341 A1 to Bolea et al. (“Bolea ‘341”).
As to claim 32, Wolford does not appear to disclose wherein the therapeutic device comprises a vibratory stimulus of progressively increasing pulse width and pulse repetition rate.
However, in a related process, Bolea ‘341 discloses the use of a therapeutic device comprises a vibratory stimulus of progressively increasing pulse width and pulse repetition rate (see [0114]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the bio-feedback mechanism of Wolford with the vibratory stimulus of progressively increasing pulse width and pulse repetition rate of Bolea ‘341 in order to achieve the predictable result of gently waking the subject.
Claims 36, 38 and 41 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wolford in view of Takishima and further in view of Bolea ‘442 and further in view of an article entitled “Electrical stimulation of the hypoglossal nerve in the treatment of obstructive sleep apnea” by Kezirian et al. (“Kezirian”).
As to claim 36, Takishima further discloses wherein the therapeutic device is configured for electrical stimulation with a stimulation frequency, amplitude and pulse duration, wherein the stimulation frequency is in a range between 50 to 100 Hertz ((see col 1, lns 43-48 and col 2, ln 1-11), but fails to disclose wherein the therapeutic device is configured to invasively and directly stimulate the hypoglossal nerve.
This is shown by Kezirian (see Fig 1 and associated text). It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the noninvasive stimulation of Takishima to invasively and directly stimulate the hypoglossal nerve in order to achieve the predictable result of precisely controlling where along the nerve that the stimulation is placed.
As to claims 38 and 41, neither Wolford nor Takishima discloses wherein the therapeutic device is configured to provide stimulation at the onset of inspiration to obtain an improvement in respiratory airflow. Kezirian does teach that providing stimulation at the onset of inspiration to obtain an improvement in respiratory airflow (see p. 301 – Timing of the stimulation with respect to the respiratory pattern). It would have been obvious to one of ordinary skill in the art at the time the invention was made to implement this instruction by Kezirian for this expressed purpose.
Claims 37 and 40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Wolford in view of Takishima and further in view of Bolea ‘442 and further in view of Kezirian and further in view of US 5,190,053 A to Meer.
As to claim 37 and 40, none of the above references disclose wherein the therapeutic device is configured to provide stimulation with the pulse duration in a range of durations, wherein the range of durations comprises a pulse duration of about 0.4 milliseconds. However, Meer discloses a similar stimulation scheme and duration (see col 6, ln 40-47 – approximately 0.4 milliseconds). It would have been obvious to one of ordinary skill in the art at the time the invention was made to perform the stimulation duration of Meer as Meer teaches that such durations are successful in treating apnea.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot given the new grounds of rejection.
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 Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-F, 830am-5pm.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 571-272-5596. 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.
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791