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
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 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) 2, 4-6, 10, 12, 14-16, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Besslen (Pub. No.: US 2004/0167404) in view of Seth et al (Pub. No.: US 2013/0289353).
Regarding claims 2, 5-6, 12, 15, Bessler discloses a device for characterizing a tympanic membrane of a subject the device comprising:
a transducer configured to transmit a transmit signal comprising waves to the tympanic membrane [see 0007, 0018, 0023, 0026];
a detector configured to receive a receive signal from the tympanic membrane generated in response to the transmitted waves [see 0007, 0023, 0026, 0038, 0044] by disclosing the transducer was operated in transmitter-receiver mode such that the same transducer was used for pulse generation and detection of echoes in A-mode [see 0038]
a processor configured to distinguish a type of effusion associated with the tympanic membrane between serous effusion, mucoid effusion, purulent effusion, or a combination thereof based on the received signal from the tympanic membrane and the optical signal [see 0006-0007, 0033, 0040, 0042-0043].
Bessler doesn’t disclose an optical signal directed to a region of interest on the tympanic membrane.
Nonetheless, Seth et al disclose an optical signal directed to a region of interest on the tympanic membrane [see 0052] by disclosing accurate and stable positioning of the laser diode module so that the beam could be aimed through the opening of the speculum and illuminate onto the tympanic membrane surface [see 0052, 0056-0058].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bessler and Seth et al by using an optical signal directed to a region of interest on the tympanic membrane; so that the beam could be aimed through the opening of the speculum and illuminate onto the tympanic membrane surface [see 0052].
Regarding claims 4, 14, Bessler discloses wherein the transducer is configured transmit the transmit signal through the air to the tympanic membrane [see 0026, 0029].
Regarding claims 6, 16, Bessler discloses wherein the transmit signal comprises a continuous wave (CW) transmit signal or a pulsed transmit signal [see 0023, 0025-0026].
Regarding claims 10, 20, Bessler discloses wherein the transducer has a repetition rate of less than 15Khz [see 0038] by disclosing frequency of pulse repetition of 100 Hz [see 0038].
Claim(s) 3, 8, 13, 18 are rejected under 35 U.S.C. 103 as being unpatentable over Besslen (Pub. No.: US 2004/0167404) in view of Seth et al (Pub. No.: US 2013/0289353) as set forth in claim 2 above and further in view of Combs et al (US Pat: 5, 868, 682).
Regarding claims 3, 13, Bessler discloses the presence of fluid behind the membrane 6 fold decrease of the echo amplitude at center frequency, allowing for high accuracy detection of the fluid presence behind the membrane [see 0040];
wherein a characterization of the type of effusion is based a determination of one or more of a viscosity of a fluid adjacent to the tympanic membrane [see 0008, 0015, 0030-0033] or a mobility of the tympanic membrane, the one or more of the viscosity of the fluid or the mobility of the tympanic membrane based at least in part on a phase output [see 0008, 0015, 0030-0033, 0046].
Bessler discloses the differentiation between serous (thin) and mucoid (thick) and purulent effusion fluid by analysis of the ultrasonic signal attenuation of the echo signal reflected from the back of the inner ear. The attenuation is determined, for example, by comparing power spectra obtained by Fourier transformation of the original and reflected pulse. The center frequency shift resulting from attenuation of the echo is correlated with the viscosity of the fluid [see 0025]
Bessler and Seth et al don't mention wherein the receive signal from the tympanic membrane is representative of a phase and an amplitude of reflected waves from the tympanic membrane and wherein the phase output comprises a comparison a phase of the transmitted waves to the phase of the reflected waves.
Nonetheless, Combs et al disclose wherein the receive signal from the tympanic membrane is representative of a phase and an amplitude of reflected waves from the tympanic membrane [see column 6 lines 50-65, column 7 lines 1-65, column 8 lines 1-10, fig 4] and wherein the phase output comprises a comparison a phase of the transmitted waves (which a low amplitude wave, emphasis added) to the phase of the reflected waves (which is a large wave due to the presence of effusion, emphasis added) [see column 6 lines 50-65, column 7 lines 1-65, column 8 lines 1-10, fig 4]
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bessler, Seth et al and Combs et al by having the receive signal from the tympanic membrane is representative of a phase and an amplitude of reflected waves from the tympanic membrane and the phase output comprises a comparison a phase of the transmitted waves to the phase of the reflected waves; because an ear is shown to have effusion, the middle ear effusion limits ear drum vibration which causes large reflective waves [see column 7 lines 28-33].
Regarding claims 8, 18, Bessler discloses the differentiation between serous (thin) and mucoid (thick) and purulent effusion fluid by analysis of the ultrasonic signal attenuation of the echo signal reflected from the back of the inner ear. The attenuation is determined, for example, by comparing power spectra obtained by Fourier transformation of the original and reflected pulse. The center frequency shift resulting from attenuation of the echo is correlated with the viscosity of the fluid [see 0025].
Bessler and Seth et al don't disclose the mobility of the tympanic membrane is a scattering metric.
Nonetheless, Combs et al disclose using a scattering metric (reflectivity of the signals, emphasis added) to measure the mobility (limited vibrations of the ear drum (tympanic membrane)) of the tympanic membrane [see column 7 lines 13-65, column 8 lines 1-44] by disclosing an ear 100 is shown to have effusion 110. The middle ear effusion limits ear drum vibration which causes large reflective waves as indicated at 109 and by disclosing the reflectivity at the null point generally indicates middle ear problems when it is greater than 5.0 units on the scale of the Model 501 Acoustic Otoscope [see column 7 lines 29-44].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bessler, Seth et al and Combs et al by using a scattering metric to measure effusion; so that effusion can be measured with high accuracy.
Claim(s) 7, 9, 17, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Bessler (Pub. No.: US 2004/0167404) in view of Seth et al (Pub. No.: US 2013/0289353) as set forth in claim 2 above and further in view of Combs et al (US Pat: 5, 868, 682) as applied to claim 3 above and further in view of Voie et al (Pub. No.: US 2007/0129632).
Regarding claim 7, 17, Bessler discloses the difference between echoes from the membrane-air interface and from the back of inner ear will be in the range of 13.2 mu.s. Selective time-domain gating of pulses will allow distinguishing respective echo sources based on the elapsed time [see 0029].
Bessler, Seth et al, Combs don't disclose wherein the phase output comprises a time delay of the received reflected waves.
`Nonetheless, Voie et al disclose a time delay of the reflected waves [see 0081, 0086].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bessler, Combs et al, Seth et al and Voie et al by using a time delay of the received reflected waves; for accurate diagnosis.
Regarding claim 9, 19, Bessler doesn’t disclose Doppler ultrasound signal.
Nonetheless, Voie et al disclose Doppler ultrasound signal [see 0073].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bessler, Combs et al, Seth et al and Voie et al by Doppler ultrasound signal; Doppler signal technology in ultrasound allows non‑invasive, real‑time measurement of blood flow speed, direction, and vascular resistance, enabling early detection of cardiovascular and vascular diseases without radiation exposure.
Claim(s) 11, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bessler (Pub. No.: US 2004/0167404) in view of Seth et al (Pub. No.: US 2013/0289353) as set forth in claim 2 above and further in view of Heller et al (US Pat: 4, 688, 582).
Regarding claims 11 and 21, Bessler and Seth et al don't disclose advancing a speculum tip into an ear canal of the subject, wherein transmitting the transmit waves to the tympanic membrane comprises passing the transmit signal through the speculum tip advanced into the ear canal, wherein receiving the signal from the tympanic membrane generated in response to the transmitted transmit waves comprises passing the receive signal through the speculum tip advanced into the ear canal and to the detector.
Nonetheless, Heller et al disclose advancing a speculum tip into an ear canal of the subject [see column 2 lines 33-55] by disclosing the distal end of the speculum 17 is adapted to enter the canal of the ear being examined [see column 2 lines 33-55];
wherein transmitting the transmit waves to the tympanic membrane comprises passing the transmit signal through the speculum tip advanced into the ear canal and wherein receiving the signal from the tympanic membrane generated in response to the transmitted transmit waves comprises passing the receive signal through the speculum tip advanced into the ear canal and to the detector [see column 2 lines 33-55 and claims 1, 6, 17, 26] by disclosing a pair of transducers in the form of a speaker 21 and microphone 22 are mounted in the speculum 17 as indicated in FIG. 3. The speaker transmits acoustic signals of uniform frequency into the ear canal and the microphone 22 receives the signals that are reflected back through the canal by the tympanic membrane at the inner end of the canal [see column 2 lines 33-55].
Heller et al disclose a speculum on said casing and including means to sealably engage the canal of an ear being examined, means in the speculum for emitting signals into the ear canal, means in the speculum to receive the signals reflected back through the canal by a tympanic membrane [see claims 1, 6, 17, 26]. The signals that are transmitted and received by the speaker 21 and microphone 22, FIGS. 3 and 8, in the speculum 17 are generated and processed by a custom integrated circuit 79, FIG. 8 [see column 6 lines 15-18].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bessler, Seth et al and Heller et al by advancing a speculum tip into an ear canal of the subject; transmitting the transmit waves to the tympanic membrane comprises passing the transmit signal through the speculum tip advanced into the ear canal and receiving the signal from the tympanic membrane generated in response to the transmitted transmit waves comprises passing the receive signal through the speculum tip advanced into the ear canal and to the detector; the benefits of speculum tips include improved access and visual field, user-friendly design, and optimal manipulation. These features contribute to a more comfortable and efficient examination process, reducing patient anxiety and enhancing the overall experience.
Response to Arguments
Applicant's arguments filed 7/23/2026 have been fully considered but they are not persuasive. .
Applicant argues the cited references don’t disclose "a processor configured to distinguish a type of effusion associated with the tympanic membrane between serous effusion, mucoid effusion, purulent effusion, or a combination thereof based on the receive signal from the tympanic membrane and the optical signal".
The examiner disagrees because Nonetheless, Seth et al disclose an optical signal directed to a region of interest on the tympanic membrane [see 0052] by disclosing accurate and stable positioning of the laser diode module so that the beam could be aimed through the opening of the speculum and illuminate onto the tympanic membrane surface [see 0052, 0056-0058].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Bessler and Seth et al by using an optical signal directed to a region of interest on the tympanic membrane; so that the beam could be aimed through the opening of the speculum and illuminate onto the tympanic membrane surface [see 0052].
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 JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3797
