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 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.
Claims 1-14 are 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 1 recites the limitation “it” in line 4. There is insufficient antecedent basis for this limitation in the claim, as it is unclear to which entity “it” refers. For examination purposes, the limitation will be read as referring to the system. Dependent claims 2-14 are necessarily rejected as depending upon a rejected base claim.
The following limitations in claims 1, 4, 8, and 10 have insufficient antecedent basis:
Claim 1: “the diagnosis,” “the electroencephalographic signal,” “the electrooculography signal,” “the electromyography signal,” “the mouth,” “the nose,” “the respiration rhythm,” “the signal,” “the carbon dioxide”
Claim 4: “the walls”
Claim 8: “the limbs”
Claim 10: “the detected signal,” “the data”
Dependent claims 2-3, 5-7, 9, and 11-14 are necessarily rejected as depending upon rejected base claims.
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.
Claims 1-3, 5-8, 10, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Opperman et al. (US Patent No. 10,786,693), hereinafter Opperman.
Regarding claim 1, Opperman discloses a biomedical parameters monitoring system for a diagnosis of sleep disorders (col 6, lines 64-66: “the present invention is envisioned as being usable with systems such as sleep masks, anesthesia delivery systems, oxygen masks and the like”),
including a plurality of sensors reading a series of biometric parameters (col 11, lines 29-34: “a breathing mask or system with one or more of the sensors mentioned herein such as gas sensors, organic compound (volatile or non-volatile) sensors, flow sensors, temperature sensors, heat flux sensors, respiration sensors, pressure sensors, physiological electrodes such as ECG, EMG, EOG, and EEG”)
and one or more external devices collecting the data read by the sensors to make the diagnosis (Fig. 5: processor 125; col 64, lines 47-52: “The processor 125 comprises an algorithm which receives the sensor signals, and uses the measured values to calculate a plethora of metrics related to […] biometric breathing conditions, health, environment, metabolic conditions, and the like”),
wherein the system includes a facial support on which at least one sensor is mounted for reading an electroencephalographic signal, an electrooculography signal, and an electromyography signal (Fig. 1: breathing mask 10; col 43, lines 36-41: “Different types of sensors for measuring physiological signals from the subject can be used preferably when these sensors can be incorporated into a facemask. These sensors include electrodes for measuring electro-physiological signals such as EEG, ECG, EMG, ENG, ERG, EOG and the like”),
in which the facial support has a central part, suitable for being located at a mouth and a nose (Figs. 1-5: breathing mask 10 configured to be positioned at a mouth and nose),
on which a sensor is mounted to read a respiration rhythm and a signal of carbon dioxide emitted (col 10, lines 43-60: “the systems, devices, and methods, and particularly the sensors, of the present invention are designed to be either interchangeable between breathing mask and nasal cannula breathing systems, or are adapted to be used with one or the other [...] Physiological data such as the subject's ventilation, fractional concentration of expired oxygen (FEO.sub.2), fractional concentration of expired carbon dioxide (FECO.sub.2), breath-by-breath volume (BV), breath frequency (BF), […] are among the many types of data, profiles and metrics that can be acquired”),
wherein each of the sensors is provided with a radio transceiver to transmit data to said one or more external devices (col 11, lines 42-45: “The sensors in the mask or system can be tethered wirelessly or by electrical connection. The wireless tethering can be through radio frequency”).
Regarding claims 2-3, Opperman discloses the system of claim 1 as described previously. Opperman further discloses wherein the facial support has a mask configuration, and the central part of the facial support is concave and protruding (Figs. 1-3: breathing mask 10 having a concave, protruding mask configuration).
Regarding claim 5, Opperman discloses the system of claim 1 as described previously. Opperman further discloses wherein a sensor for measuring heart rate, blood oxygen saturation and movement is mounted on the facial support (col 22, lines 52-53: “a pulse oximeter may be incorporated into a mask”).
Regarding claim 6, Opperman discloses the system of claim 1 as described previously. Opperman further discloses wherein a sensor for reading respiratory sound and for reproducing sound or voice messages is also mounted on the facial support (col 21, lines 10-13: “These sensors or devices, also preferably measure nasal pressure, respiratory inductance plethysmography, thoracic impedance, expired carbon dioxide, tracheal sound, snore sound, blood pressure and the like;” col 61, lines 64-67: “One or more microphones may be incorporated into the breathing mask 10. The primary microphone allows the subject to communicate with other team members or remote monitoring stations and personnel”).
Regarding claim 7, Opperman discloses the system of claim 1 as described previously. Opperman further discloses wherein the system includes a sensor for measuring thoracic expansion and a sensor for measuring abdominal expansion (col 21, lines 28-36: “Respiration belts can be used to measure a subject's abdominal and/or thoracic expansion over a measurement time period. The respiration belts may contain a strain gauge, a pressure transducer or other sensors, which can indirectly measure a subject's respirations and the variability of respirations by providing a signal, which correlates to the thoracic/abdominal expansion/contractions of the subject's abdominal cavity”).
Regarding claim 8, Opperman discloses the system of claim 1 as described previously. Opperman further discloses wherein the system includes sensors for measuring movement of the limbs (col 45, lines 4-5: “Accelerometers may be used to measure determine the subject's body position and orientation”).
Regarding claim 10, Opperman discloses the system of claim 1 as described previously. Opperman further discloses wherein each of the sensors includes an energy accumulator and a management module for charging/discharging the energy accumulator to supply energy to the sensor components, wherein inside the sensor the detected signal is amplified, converted by an analog-digital converter, and sent to a microcontroller connected to the radio transceiver which communicates the data sampled over time to the external device (col 49, lines 47-66: “The one or more electronic components may include circuitry for […] electrode amplifiers, signal filters, analog to digital converter, RF output antenna, RF input antenna, RF output/input antenna, […] a DC power source and combinations thereof. The one or more electronic components may comprise one processing integrated circuit, multiple integrated circuits, single function components or combinations thereof, which can perform all of the necessary functions of detecting the sensor or physiological signal(s), transmitting a signal corresponding to the sensor signal(s) to a receiving unit and optionally receiving a signal from a remote transmitter. These one or more electronic components can be assembled on a printed circuit board or by any other means known to those skilled in the art”).
Regarding claim 13, Opperman discloses the system of claim 1 as described previously. Opperman further discloses wherein the facial support is made of soft elastic material (col 57, lines 54-56: “The breathing mask 10 is constructed of flexible, non-irritant materials commonly known to those of skill in the art for producing such masks”).
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.
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.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Opperman in view of Kayyali et al. (US Patent No. 9,615,773), hereinafter Kayyali.
Regarding claim 4, Opperman teaches the system of claim 1 as described previously, but does not explicitly teach wherein walls of the central part of the facial support are provided with ventilation inlets. However, in an analogous art, Kayyali teaches a mask-shaped biomedical monitoring system wherein walls of a facial support are provided with ventilation inlets (Fig. 8: air ports 210) to allow for breathing by the user (col 26, lines 18-20: “The mask 106 shown in FIG. 8 includes air ports 210 to allow for relatively unhindered breathing by the subject, while the mask is worn”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Opperman by providing air ports on the mask, as taught by Kayyali, in order to allow for breathing by the user, as taught by Kayyali.
Regarding claim 14, Opperman teaches the system of claim 1 as described previously, but does not explicitly teach wherein the facial support is provided with adjustable straps. However, Kayyali further teaches adjustable straps for the mask (Fig. 6: strap 208), which allows the mask to be held tightly over the user’s mouth and nose (col 25, lines 42-44: “The mask is held tightly over the subject's mouth and nose by a strap 208 used to secure the mask to the subject 200”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the system of Opperman with adjustable straps, as taught by Kayyali, in order to allow the mask to be held tightly over the user’s mouth and nose, as taught by Kayyali.
Claims 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Opperman in view of Mumford et al. (US PGPub No. 2007/0208269), hereinafter Mumford.
Regarding claim 9, Opperman teaches the system of claim 1 as described previously, but does not explicitly teach wherein pockets are formed in the facial support, inside which the sensors mounted on the facial support are received. However, in an analogous art, Mumford teaches a mask-shaped biomedical monitoring system having pockets inside with sensors are received, which provides a removable attachment means for electrodes requiring minimal preparation of the user’s skin (par. 0063: “the attachment means may be circular apertures, or a cutout portion, with an inner metallic contact, which may be a metallic ring. The apertures are sized to receive cylindrical electrodes which have a plastic portion, a solid conductive gel portion and a metallic conductor disposed there between. […] These electrodes require minimal preparation of the skin of the CPAP wearer 18 and the electrodes can be used for several nights before having to be replaced”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the system of Opperman with apertures in the mask, as taught by Mumford, so that electrodes requiring minimal preparation of the user’s skin can be removably attached, as taught by Mumford.
Regarding claim 11, Opperman teaches the system of claim 1 as described previously. Opperman further teaches wherein the sensor for reading the electroencephalographic signal and the electrooculography signal and the sensor for reading the electromyography signal are connected to respective electrodes mounted on the facial support (col 59, lines 46-53: “At least one electrode, preferably a dry surface electrode, may be included, either in the mask or otherwise on the subject’s body. Dry surface electrodes may be used to detect and measure electroencephalography (EEG), electrocardiography (ECG), electromyography (EMG), electrooculography (EOG), heart rate, or other physiological signals which may be used to help determine the subject's physiological state”). Opperman is silent with respect to the placement of conductors between sensors and electrodes and does not explicitly teach wherein the conductors are incorporated into the facial support. However, Mumford further teaches incorporating wires in the mask assembly so that the mask can be used with peel and stick electrodes (par. 0064: “The peel and stick electrode may be held in place by a fastener that ensures that the metallic backing makes electrical contact with a corresponding wire in the mask assembly 12”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate wires in the mask assembly, as taught by Mumford, so that the mask could be used with peel and stick electrodes, as taught by Mumford.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Opperman in view of Mumford and further in view of Mendes et al. (WO 2016/166740), hereinafter Mendes.
Opperman in view of Mumford teaches the system of claim 11 as described previously. The combination does not explicitly teach wherein the electrodes are each provided with an elastically retractable contact tip. However, in an analogous art, Mendes teaches a biomedical monitoring system using electrodes each with an elastically retractable contact tip (par. 0012: “the electrode comprises a plurality of retractable electrode pins”), which provides an improved mechanical interface capable of adjusting for small movements (par. 0005 and 0007: “The electrodes present as key features: avoidance of preparation for signal acquisition (i.e. no need for electrolytic gel); and a mechanical interface which allows a better adaptation of the electrode to any form of the scalp surface. […] Small movements of the cap or electrode, for instance generated by the difference of pressure applied between the top and side of the inner cap, do not affect the acquisition of the signals once the electrode pins has the ability to actively shape and compensate these movements”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the electrodes of the combined system by providing the electrodes with elastically retractable contact tips, as taught by Mendes, for an improved mechanical interface, as taught by Mendes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Platt et al. (US PGPub No. 2004/0035423) teaches a biomedical sleep monitoring system with a mask made of soft plastic material with ventilation holes.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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