DETAILED ACTION
Response to Arguments
Applicant's arguments filed 4/3/2026 have been fully considered but they are not persuasive.
Applicant argues that Magnussen does not disclose “outputting an effusion metric” because Magnussen discloses middle-ear resonance to diagnose bone-related pathologies, not effusion, and an effusion is “an abnormal collection of fluid”.
The Examiner disagrees and respectfully submits that the limitation “effusion metric” is not defined in Claims 2 and 15. Under broadest reasonable interpretation, the limitation “effusion metric” is interpreted as set forth in the claims in light of the specification and claims that further define the effusion metric. Specifically, Claim 19 defines effusion metric as based on a corner frequency in a frequency response function and Claim 11 defines it as a comparison of corner frequency to a threshold frequency. The specification a [0007], [0021] and [0028] describe the effusion metric in terms of the transfer function and the corner frequencies and Magnussen discloses exactly this at [0075] and [0076]. The output of Magnussen’s analysis is structurally the same metric Applicant’s dependent claims identify as the effusion metric.
Furthermore, the Applicant’s argument that Magnussen is limitation to bone-related pathology is unpersuasive. At [0010] of Magnussen, it is taught that middle-ear pathology generally alters tympanometry shapes and shift resonance frequency, and explicitly cite otosclerosis as one example (stiffness shift) and ossicular discontinuity as another (mass shift). These are the same mass/stiffness the Applicant’s specification attributes to fluid at [0019]-[0022] – the prior art of record and the Applicant’s specification use the same physical measurements to characterize a middle-ear state.
Additionally, even accepting the Applicant’s arguments that Magnussen characterizes bone-related pathologies, that characterization still reads on the broadly claimed “effusion metric” under broadest reasonable interpretation. The claim requires only that the metric be based at least in part on the comparison of the input waveform with the output waveform” it does not require the metric to diagnose effusion, only that it be in some way informative of effusion status. Magnussen’s resonance-shift provides that information, especially when Applicant’s own specification describes effusion detection in the same mass/stiffness/corner-frequency terms Magnussen uses.
The Applicant argues that the claimed effusion metric “improves treatment choices” for viral vs. bacterial infections and addresses clinical dilemma not addressed in Magnussen.
The Examiner disagrees and respectfully submits that the Applicant’s arguments are not commensurate in scope with the claimed invention. Claims 2 and 15 only recite generating, receiving, comparing, and outputting steps – the claims require no diagnostic, no distinction between viral and bacterial infection, no correlation with fluid type, and no treatment. A statement of purpose of intended use in the specification does not impose a limitation upon the claim. If the Applicant intends the metric to have a diagnostic for effusion, that limitation must appear in the claim.
Applicant argues that dependent Claims 3-14 and 16-22 recite additional elements and are therefore patentable for the same reasons as Claims 2 and 15. The Examiner disagrees and respectfully submits that because the rejections of Claims 2 and 15 are maintained, this argument is unpersuasive. Furthermore, it is noted that Claims 3-7 and 18-22 were indicated as allowable, and the Applicant has not pointed out any deficiencies with respect to rejected dependent Claims 9, 10, 12-14, 16 and 17.
The Applicant argues that Claim 11 is patentable over Magnussen in view of Ozturk because Ozturk does not disclose an input waveform distinct from the output waveform. The Examiner disagrees and respectfully submits that Magnussen supplies the argued limitation through wideband acoustic immittance analysis at [0075]. Ozturk is replied upon for the threshold frequency corresponding to normal versus mucoid tympanic membranes. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 102 - MAINTAINED
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.
Claim(s) 2, 9, 10, 12-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20190038189 A1 to Magnussen et al. (hereinafter, Magnussen).
Regarding Claim 2, Magnussen discloses a method of characterizing an ear, the method comprising inter alia:
generating, with an excitation source, dynamic volume or pressure in an ear canal ([0006] “…ear probe has a loudspeaker for emission of sound…”) with a speculum tip coupled to the ear canal ([0006] “…an ear probe is inserted in the ear canal…”), the dynamic volume or pressure being based on an input waveform ([0006] “… typically a 226 Hz pure tone, towards the tympanic membrane…”);
receiving one or more pressure sensor measurements from a pressure sensor coupled to the speculum tip coupled to the ear canal, the one or more pressure sensor measurements comprising an output waveform ([0006] “emitted sound is reflected and picked up by a microphone of the ear probe”);
comparing the input waveform for the dynamic volume or pressure with the output waveform ([0075] “…determining wideband acoustic immittance F(f) as a function of frequency f based on the output audio signal and the input audio signal…”); and
outputting an effusion metric based at least in part on the comparison of the input waveform with the output waveform ([0186] “…identifying a possible middle ear resonance of a possible plurality of middle ear resonances based on another determined wideband acoustic immittance F(f) than the admittance Y(f), by calculating the admittance Y(f) based on the determined wideband acoustic immittance F(f)…”.).
Regarding Claim 9, Magnussen discloses the method of claim 2, wherein the input waveform of the excitation source is sinusoidal ([0006] “… typically a 226 Hz pure tone, towards the tympanic membrane…” as Hz is cycles per second and a cycle refers to a repeating oscillation that is represented by a sine or cosine function, which are inherently sinusoidal pure tones, by having a single frequency, amplitude and phase).
Regarding Claim 10, Magnussen discloses the method of claim 9, wherein the input waveform of the excitation source and the output waveform of the one or more pressure measurements are acquired over several frequencies ([0009] “With the so-called sweep pressure method, the frequency of the pure tone is held constant while the static pressure is varied; and with the so-called sweep frequency method, the static pressure is held constant at specified intervals while the frequency of the pure tone is varied.”) to determine a corner frequency ([0076] “…identifying a middle ear resonance based on the determined wideband acoustic immittance F(f) at a resonance frequency fres at which an acoustic admittance Y(f)=G(f)+jB(f) corresponding to, or calculated from, the determined wideband acoustic immittance F(f) fulfils that the conductance G(fres) is a global or local maximum of the conductance G(f) and that the gradient B′(fres) of the susceptance B(f) is a global or local minimum of the gradient B′(f).” here the global or local maximum is the corner frequency).
Regarding Claim 12, Magnussen discloses the method of claim 2, wherein the excitation source comprises a moveable diaphragm ([0073] “…providing an output audio signal to the loudspeaker for conversion into sound for transmission towards a tympanic membrane of the ear and spanning a frequency range…”) or a source of differential pressure coupled to the speculum tip with a hose ([0095] “…the ear probe may have a static pressure output port and an air conduit connected to the static pressure output port, and the cable interconnecting the housing of the apparatus with the ear probe may comprise an air conduit for interconnection of the air conduit of the ear probe with the air pump or compressor for applying the static pressure p to the ear canal…”).
Regarding Claim 13, Magnussen discloses the method of claim 2, wherein the excitation source comprises a diaphragm or piston enclosed in the speculum tip or a mount for the speculum tip ([0031] “The ear probe may accommodate one of, or both of, the loudspeaker and the microphone.”).
Regarding Claim 14, Magnussen discloses the method of claim 2, wherein the excitation source is coupled to a source of greater or lower air pressure through one or more valves ([0095] “…the static pressure p in the ear canal can be controlled utilizing the air pump or compressor.”).
Regarding Claim 15, Magnussen discloses a method of characterizing an ear, the method comprising inter alia:
modulating pressure within an ear canal with an excitation source coupled to a speculum tip inserted within the ear canal, the speculum tip forming a seal when inserted into the ear canal ([0158] “The ear probe 12 seals the ear canal 100 with an air tight seal so that the static pressure p in the ear canal 100 can be adjusted with the air pump or compressor 36 as controlled by the processor 28.”);
measuring the pressure within the ear canal with a pressure sensor coupled to the speculum tip ([0158] “… an air pump or compressor 36 accommodated in the housing 14 for provision of a static pressure p in the ear canal 100. The processor 28 is adapted for controlling the static pressure p provided by the air pump or compressor 36 with control signal 34. The static pressure p is applied to the ear canal through an air conduit 38of the cable 18 and through an air conduit (not visible) through the ear probe 12.” indicating that pressure is both modulated and measured through the sealed conduit);
generating an excitation source input waveform, wherein the pressure within the ear canal is modulated based on the excitation source input waveform ([0154] “The housing 14 further accommodates a processor 28 that is adapted for controlling the loudspeaker 16 to emit sound spanning a frequency range by generation of an output audio signal 30 that is input to the loudspeaker 16 for conversion into the corresponding emitted sound transmitted through the air conduit 20 of the cable 18 and through the acoustic output port (not visible) of the ear probe 12 and into the ear canal 100 for propagation towards the tympanic membrane 112 at the end of the ear canal 100.”);
receiving a pressure measurement output waveform based on the measured pressure ([0155] “The processor 28 is also connected to the output of the microphone 22 for reception of the input audio signal 26 generated by the microphone 22 in response to sound received at the input port of the ear probe 12.”);
determining an effect of the excitation source input waveform on the pressure measurement output waveform ([0160] “The processor 28 is adapted for identifying a middle ear resonance…”);
comparing the pressure measurement output waveform with the excitation source input waveform ([0160] “…comparing characteristics of the determined immittance F(f, p) with the characteristics of a resonance…”); and
generating an effusion metric based at least in part on a comparison of the excitation source input waveform with the pressure measurement output waveform ([0163] “The processor 28 is further adapted for identifying one or more middle ear resonances, if any, based on the wideband acoustic immittance F(f) determined at ambient pressure pamb.”).
Regarding Claim 16, Magnussen discloses the method of claim 15, wherein the excitation source is configured to cause a volume change or a pressure change within the ear canal ([0212] “Thus, the processor 28 is adapted for performing wide band acoustic immittance measurements by controlling the air pump or compressor 36 to provide static pressures p spanning a static pressure range…”).
Regarding Claim 17, Magnussen discloses the method of claim 15, wherein the excitation source is a moving diaphragm ([0073] “…providing an output audio signal to the loudspeaker for conversion into sound for transmission towards a tympanic membrane of the ear and spanning a frequency range…”).
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.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Magnussen in view of “Transient responses to tone bursts” to Lewis et al. (hereinafter, Lewis).
Regarding Claim 8, Magnussen discloses the method of claim 2. Sullivan does not expressly disclose wherein the input waveform of the excitation source is trapezoidal. However, Lewis teaches generating controlled acoustic stimuli to the ear canal and interpreting resulting acoustic responses and further teaches using trapezoidal tone burst (Abstract). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modifying the waveform of Magnussen to be the trapezoidal waveform of Lewis, as Lewis teaches in the Abstract in conclusions (1)-(4) that each corner of the trapezoid is an identifiable transient event where the trapezoidal corners act as discrete events enabling time-domain resolution of natural frequencies and further state in the second paragraph of the Abstract that the conclusion is that a trapezoidal waveform would have been well suited to extract temporal information.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Magnussen in view of “The Value of Multifrequency Tympanometry in the Management of Otitis Media with Effusion” to Ozturk et al. (hereinafter, Ozturk).
Regarding Claim 11, Magnussen discloses the method of claim 10. Magnussen does not expressly disclose wherein outputting the effusion metric comprises comparing the corner frequency to a threshold frequency corresponding to one or more of a normal tympanic membrane or a mucoid fluid adjacent to a tympanic membrane (page 7, column 1 “The normal 90% range for middle ear RF was 650 Hz– 1350 Hz in this study.” and “Stiffness and mass components of the middle ear system are frequency dependent. The RF of the middle ear system may be shifted higher or lower compared to normal ears by various pathologies.”) (page 6, column 1 “Mean RF value of the mucoid and the serous groups were 478 Hz (250-650 Hz; SD: 111.6 Hz) and 643 Hz (250-1450 Hz; SD: 282.4 Hz) respectively (p<0.05).”). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the corner frequency of Magnussen to be compared a threshold frequency corresponding to one or more of a normal tympanic membrane or a mucoid fluid adjacent to a tympanic membrane of Ozturk as Ozturk teaches frequency thresholds and diagnostic categorizations demonstrated specificity, giving a clear indication of the normal versus mucoid impacted tympanic membranes (page 4, col. 1).
Allowable Subject Matter
Claims 3-7 and 18-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791
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