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 § 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.
Claim(s) 1-2, 4, 12-13 and 15-20 is/are rejected as being unpatentable over Kaiser further in view of Andersen US 2018/0206788.
Regarding claim 1, Kaiser discloses a device for detecting brain activity of a mammal, the device comprising at least one earpiece configured to be worn on an ear of the mammal, the earpiece ([¶13,24] earpiece housing comprises element 140) comprising:
a main body comprising a housing portion configured to be received in the ear conch of the ear of the mammal ([FIG1][¶13,24] housing 140 which is received in the conch) and an elongation portion which extends transversally from a lateral wall of the housing portion along an elongation axis ([FIG1][¶47] portion 142 extends from the lateral wall of 140), the elongation portion being configured to be inserted into an ear canal of the ear of the mammal ([FIG1] the elongation portion fits within the ear), and
an earmold configured to be inserted into an ear canal of the ear of the mammal ([FIG1][¶11] the earpiece tip indicated by 112), said earmold having a channel extending along a earmold axis ([FIG1][¶24] interface 120), and a skirt surrounding the channel ([FIG1][¶11] elastic substrate 112), the channel being adapted to receive said elongation portion to removably mount the earmold onto the main body ([¶12] the elastic tip portion is removable and replaceable from the portion 142), at least the skirt of the earmold being made of an elastically deformable material ([¶32] substrate 112 is made of elastic material), said earmold comprising at least one electrode assembly, the electrode assembly comprising a measurement electrode arranged on an outer surface of the skirt of the earmold to contact the ear canal and configured to deliver an electrical signal representative of the brain activity of the mammal, said electrical signal having an electrical intensity ([¶8] three electrodes on substrate 12 are used for sensing);
a processing unit arranged in the housing portion of the main body ([FIG1] signal acquisition subsystem 130), said earpiece comprising at least one first electrical track arranged in said channel of the earmold and connected to the measurement electrode, and at least one second electrical track arranged in said elongation portion of the main body and configured to convey the electrical signal delivered by at least one measurement electrode to the processing unit ([FIG1][¶27,47] electrical tabs 122), wherein the electrode assembly comprises a preamplifier having an intensity gain adapted to adapt the electrical intensity of the electrical signal delivered by the measurement electrode of said electrode assembly ([¶11,12,50] the preprocessing includes amplifiers), the preamplifier being positioned upstream of the processing unit in a direction of propagation of the electrical signal delivered by the measurement electrode of said electrode assembly ([¶50] the amplification happens before signal processing so it is upstream), so that the processing unit is configured to process the electrical signal adapted in intensity from the electrode assembly ([¶50] subsystem 130 processes the intensity or amplitude)
Kaiser does not specifically disclose the preamplifier of the electrode assembly is housed in the elongation portion. Andersen teaches a similar in-ear bio signal monitoring device that uses electrodes to collect EEG signals ([¶36]) that has a preamplifier located in what would be the elongation portion that extends into the ear ([FIG8][¶61]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Kaiser with the amplifier of Andersen as that arrangement allows for the flexibility and compressibility of the in-ear component.
Regarding claim 2, Kaiser discloses the preamplifier is adapted to amplify the electrical intensity of the electrical signal detected by the measurement electrode of the electrode assembly ([¶11,12,50] the preprocessing includes amplifiers which boost the signal).
Regarding claim 4, Kaiser discloses the preamplifier presents a working frequency range extending from 0.1 Hz to I kHz ([¶84] the system processes signals from 0.5 Hz to 50 Hz which is a narrower range inside of the claimed range).
Regarding claim 12, Kaiser the earpiece is further configured to transmit a sound signal into an ear canal by means of at least one electroacoustic transducer housed in the elongation portion ([¶64] the earpiece can have a speaker), the preamplifier being attached to the electroacoustic transducer along a circumferential direction of the elongation axis ([FIG1] processing circuitry is along a circumferential direction of the axis).
Regarding claim 13, Kaiser discloses the earmold is arranged to be rotatable about the elongation axis on the elongation portion so as to allow the measurement electrode to be directed to an area of the brain of said mammal ([¶59,70] the earpiece can be rotated to be positioned in the ear), the second electrical track extending in a circumferential direction around the elongation axis on at least a portion of an outer surface of the elongation portion, the first electrical track presenting an end portion extending radially with respect to the elongation axis to be in contact with the second electrical track ([FIG1][¶27,47,60] electrical contacts 144).
Regarding claim 15, Kaiser discloses the at least one electrode assembly includes a plurality of electrode assemblies ([FIG1][¶8] each ear piece has electrodes 114, 116, 118) each comprising one measurement electrode and one preamplifier ([¶57,61] each electrode can have an amplifier).
Regarding claim 16, Kaiser discloses the plurality of electrode assemblies comprises at least first and second electrode assemblies, at least a first measurement electrode of the first electrode assembly being configured to deliver a first electrical signal and a second measurement electrode of the second electrode assembly being configured to detect a second electrical signal ([FIG1][¶8] each ear piece has electrodes 114, 116, 118), said at least first electrical track comprises at least two first electrical tracks, and said at least second electrical track comprises at least two second electrical tracks, said at least two first electrical tracks being electrically insulated from each other, said at least two second electrical tracks being electrically insulated from each other ([¶37,47,48,60] traces 122 and 144), the processing unit being configured to detect brain activity as a function of said first electrical signal delivered by said first measurement electrode and adapted in intensity by a first preamplifier of the first electrode assembly and of said second electrical signal delivered by said second measurement electrode and adapted in intensity by a second preamplifier of the second electrode assembly ([¶11,20,21,76] EEG parameters and mental states are determined from the amplified electrode signals), in particular as a function of a difference between said first electrical signal and said second electrical signal ([¶28,39,83] the differential data is used to determine mental states).
Regarding claim 17, Kaiser discloses the first and second electrode assemblies are arranged on a single earpiece, the first and second measurement electrodes being spaced apart along the earmold axis ([FIG4] electrodes 114, 116 and 118 are spaced apart), the two first electrical tracks being spaced apart along the earmold axis and the two second electrical tracks being spaced apart along the elongation axis ([FIG1] electrical tracks 122 and 144).
Regarding claim 18, Kaiser discloses the device comprises two earpieces configured to be arranged respectively in a first ear canal of the mammal and a second ear canal of the mammal and configured to convey respective electrical signals to the processing unit, and wherein the first and second electrode assemblies are arranged respectively on the two earpieces ([FIG1] earpieces 110 in either ear).
Regarding claim 19, Kaiser discloses the processing unit is further configured to determine physiological or psychological state based on the detected brain activity ([¶11,83] the device determines mental states).
Regarding claim 20, Kaiser discloses computer-implemented method for determining a physiological or psychological state of a mammal with the device according to claim 19 ([FIG1][¶50] earpiece to collect EEG data and determine mental state), said method comprising:
determining an electroencephalogram signal of the mammal based on the delivered electrical signals ([¶11,13] electrodes sense the signals),
determining an amplitude of at least one brain wave in a predefined frequency range as a function of said electroencephalogram signal ([FIG2][¶10] voltage amplitude is analyzed), and
determining a psychic state based on said amplitude of at least one brain wave by comparing said amplitude to a predetermined threshold ([FIG2][¶83] the amplitudes are fed to the model to determine mental states).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser and Andersen further in view of Kilsgaard et al. US 2014/0171775.
Regarding claims 6 and 7, Kaiser discloses using a preamplifier but does not disclose the preamplifier comprises a follower circuit. Kilsgaard teaches a similar EEG measuring earpiece device that does use a follower circuit ([FIG10][¶59] the electrodes are connected to an op amp which is an active follower circuit). Therefore, It would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Kaiser with the specific preamplifier of Kilsgaard in order to act as a low noise amplifier ([¶54]).
Regarding claim 8, Kaiser discloses using a preamplifier but does not disclose the preamplifier comprises an impedance matching circuit. Kilsgaard teaches a similar EEG measuring earpiece where the preamplifier comprises an impedance matching circuit ([¶10]). Therefore, It would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Kaiser with the specific preamplifier of Kilsgaard in order to make processing signals easier.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser and Andersen further in view of LeBoeuf et al. US 2014/0140567.
Regarding claim 9, Kaiser does not disclose the preamplifier is mounted on a printed circuit board of maximum dimension 3 mm. LeBoeuf teaches a similar physiological monitoring device implemented in an earpiece that has the preamplifier mounted on a circuit board ([¶65] a flexible circuit board can mount the electronics). Therefore, It would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the flexible circuit board of LeBoeuf with the device of Kaiser in order to allow the board to find more within a smaller housing. LeBoeuf does not disclose the 3mm dimension, however; at the time the invention was filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to use the 3mm size because Applicant has not disclosed that 3mm or below provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected LeBoeuf, and applicant' s invention, to perform equally well with either the circuit board taught by LeBoeuf or the claimed 3mm board because both boards would perform the same function of mounting the electronics equally well considering the typical size of an earpiece
Therefore, it would have been prima facie obvious to modify LeBoeuf to obtain the invention as specified in the claim because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of LeBoeuf.
Regarding claim 10, LeBoeuf teaches the printed circuit board is made out of a flexible material, so as to be folded ([FIG8][¶65] the board is flexible).
Regarding claim 11, LeBoeuf teaches the preamplifier is adapted to amplify the electrical intensity of the electrical signal detected by the measurement electrode of the electrode assembly, and wherein said printed circuit board comprises a U-shape so as to embrace additional components embedded in the elongation portion ([FIG8][¶56,65] the board can curve and mounts the amplifiers and other electronic components).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser and Andersen further in view of Tran US 7,558,622.
Regarding claim 5, Kaiser does not disclose the preamplifier is coupled to an ESD circuit. Tran teaches a physiological collecting device that uses an ESD circuit with the amplifiers ([C91 L29-36] ESD and RFI protection circuits are used). Therefore, It would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Kaiser with the ESD of Tran in order to act as prevent RF interference and static damage ([C91 L26-36]).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaiser and Andersen further in view of Bibian et al. US 2011/0295096.
Regarding claim 21, Kaiser does not disclose comprising computing a quality index of the electrical signals delivered by the measurement electrodes based on a correlation computation between a common mode measurement and a difference between said first electrical signal and said second electrical signal or a difference between two electrical signals. Bibian teaches a similar EEG collection device that determines a signal quality based on the difference in signals ([¶67-69] impedance is measured to determine signal quality metrics). Therefore, It would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Kaiser with the signal quality metric of Bibian in order to show the user a state of signal quality ([¶17]).
Response to Arguments
Applicant's arguments filed 1/26/26 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that Kaiser does not disclose the claimed amplifier, Examiner respectfully disagrees. Intensity as it is used in the claims and the specification is not defined as the current of the signal as Applicant argues. Thus, a device that teaches the correct amplifier or buffer reads on the current claim limitations. The amplifier recited is defined as having an intensity gain adapted to adapt the electrical intensity of the electrical signal. The specification does disclose that ultimately this is a unity gain or follower circuit but that is not actually claimed. Having a gain to adapt an electrical intensity of a signal could refer to any gain as it does not place limitations on the gain. Kaiser discloses an amplifier that has high input impedance to amplify the differential from the common-mode signal, just like Applicant’s preamplifiers. Additionally, Kaiser discloses an instrumentation amplifier ([¶51]) which in its basic configuration has a buffer amplifier like the preamplifier claimed.
Regarding Applicant’s arguments against Andersen, Examiner respectfully disagrees. Andersen is relied up to teach the locations of the amplifier not the amplification gain.
Regarding Applicant’s arguments against Kilsgaard, Examiner respectfully disagrees. Kilsgaard does not teach preventing current flow. In ¶24 Kilsgaard teaches that the electrode is capacitive and thus does not require a current between the electrode and the skin and the dielectric coating is to prevent current running in the crossover between the skin and electrode. Additionally, the claim does not require that a current is sensed from the skin just that they “deliver an electrical signal representative of the brain activity.” Kilsgaard is relied on to teach the specific amplifier not the sensing system or electrodes.
Regarding Applicant’s arguments directed to LeBoeuf, Examiner respectfully disagrees. It is unclear what paragraphs Applicant is citing as LeBoeuf only has 84 paragraphs. In addition, LeBoeuf does teach a follower circuit ([FIG3][¶56]).
Regarding Applicant’s argument against Bibian, Examiner respectfully disagrees. Applicant argues that Bibian and the other references as a whole do not teach amplification for the purpose of amplifying the intensity of the signal as part of the impedance measurement process. This is not specifically claimed. The reference teach the appropriate circuits and the claims do not require that this is in terms of or part of impedance measurement. Applicant argues that the intensity amplification is a specific choice over voltage amplification for the reducing of noise and use of dry electrodes but this is not embodied in the claims. The intensity is not clearly set out as current and the structure of the amplification or the circuit should be better defined to clarify that it is a follower circuit that matches input and output voltage to amplify current.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Pedersen et al. US 2019/0253793 specifically figure 13.
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 MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/ Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791
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