DETAILED ACTION
Notice of 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 .
Response to Arguments
Applicant's arguments filed 04/07/2026 have been fully considered but they are moot in view of the new grounds of rejection.
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) 2, 3, 5, 6, 9-16, and 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farr (US 2008/0208006, of record) in view of Goldfain (US 2015/0133732, of record) in view of “In Vitro Studies and Safety Assessment of Doppler Ultrasound as a Diagnostic Tool in Rhinosinusitis” by P. Sahlstrand-Johnson. Ultraso. Med. Biol. Vol. 36, No. 12, pp.2123-2131. 2010 (Johnson).
Regarding claims 2, 9, 15, and 22, Farr discloses an otoscope system and method of using, the otoscope system comprising: a speculum configured to be advanced at least partially into an ear canal of a subject, the speculum comprising a speculum housing comprising a light conducting element, wherein a transmitted optical illumination is conducted by total internal reflection via the light conducting element, wherein the speculum housing has a lumen therewithin, and wherein the speculum housing is configured to allow a reflected signal from a tympanic membrane of the ear to propagate within the lumen from a distal end of the speculum housing to a proximal portion of the speculum housing ([0084], [0085], Fig. 10b: “OE vision module 550” receives the reflected signal). Farr does not explicitly disclose a processor, wherein the processor is configured to distinguish viral effusion from bacterial effusion of a fluid associated with the tympanic membrane based at least in part on the reflected signal which is considered a measurement signal generated by the tympanic membrane. However, Goldfain teaches using reflected light to distinguish between bacterial and viral fluid in the middle ear ([0022]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the classification of Goldfain to the reflected light captured by Farr, as to provide a means to distinguish between viral and bacterial fluid. While Farr teaches that the otoscope may be equipped with an ultrasound generator configured to direct a non-contact measurement wave to the tympanic membrane and a detector to receive the reflected non-contact measurement wave ([0059]), neither Farr nor Goldfain explicitly disclose an ‘excitation’ wave that is used to distinguish between viral and bacterial diffusion. However, Johnson clearly teaches that viral effusions are associated with low viscosity, bacterial effusions are marked by higher viscosity, and that ultrasound Doppler interrogation could reveal this difference (p.2124). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the known difference in viscosity as taught by Johnson, to the ultrasound otoscope of Farr and Goldfain, as to provide robust detection and distinction between viral and bacterial effusions.
Regarding claims 3 and 16, Farr discloses that the speculum housing comprises a light conducting core (Fig. 10b).
Regarding claims 5 and 21, Farr discloses that the speculum is removably connected to the otoscope ([0084]: “disposable ENT speculum 900”).
Regarding claims, 6 and 19, Farr discloses that the speculum housing when connected to the otoscope is axially aligned with a focal axis of an optical assembly (Fig. 10b: “OE vision module 550” is aligned with a focal axis of the speculum).
Regarding claim 8, while Farr does not explicitly disclose that the at least one lens has a focal axis and a focal length which is longer than a distance from the lens to a central obstruction within the speculum.
Regarding claims 10, 11, and 23, Farr does not explicitly disclose that both non-contact measurement and reflected signals are ultrasound signals and that hey are transmitted through the speculum housing. However, Farr does teach that ultrasound imaging and optical illumination systems and vision modules may be used together ([0059]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the integrated imaging system taught by Farr, as to provide multi-modal imaging.
Regarding claim 12, Farr discloses that the reflected signal is an image ([0085]: “transfers image data from the sensor”).
Regarding claims 13 and 14, Farr discloses that the speculum housing and light conducting element have a frustoconical shape (Fig. 10b: “900”, “906”).
Regarding claim 18, Farr discloses that at an optical assembly, directing a reflected optical illumination toward a detector to form an image on the detector (Fig. 10b: “OE vision module 550”).
Regarding claim 20, while Farr does not explicitly disclose that the optical assembly comprises a focus within a range from 12-25 mm from a distal tip of the otoscope and a depth of field of greater than 0.5 mm at a distance 12-25 mm from the distal tip of the otoscope, Farr teaches an imaging otoscope, which to one of ordinary skill in the art, would have found it obvious that there is a range of focus with respect to the imaging device and that this range may be adjusted using the appropriate and conventionally known optical elements.
Claim(s) 4, 7, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farr (US 2008/0208006, of record) in view of Goldfain (US 2015/0133732, of record) in view of “In Vitro Studies and Safety Assessment of Doppler Ultrasound as a Diagnostic Tool in Rhinosinusitis” by P. Sahlstrand-Johnson. Ultraso. Med. Biol. Vol. 36, No. 12, pp.2123-2131. 2010 (Johnson), as applied to claims 3 and 16 above, in view of Heine (US 3840004, of record).
Regarding claims 4 and 17, neither Farr, Goldfain, nor Johnson explicitly disclose that the speculum housing comprises an opaque shell. However, Heine teaches that a speculum is made from opaque plastic (2:1-3). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the opaque speculum of Heine to the otoscope of Farr and Goldfain, and Johnson, as to provide a conventional speculum.
Regarding claim 7, neither Farr, Goldfain, nor Johnson explicitly disclose that the optical assembly comprises at least one lens. However, Heine teaches the use of a magnifying lens (1:10). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the lens of Heine to the otoscope of Farr, Goldfain, and Johnson, as to provide a conventional optical element to direct received light.
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 extension fee 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 date of this final action.
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/JASON M IP/Primary Examiner, Art Unit 3793
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