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 .
This office action is responsive to the application filed 09/27/2023.
The preliminary amendment filed 01/26/2024 is acknowledged.
Claim Status
Claims 1-43 have been cancelled.
Claims 44-63 have been added, and are currently pending in the application.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 01/30/2024, 04/24/2024, and 07/29/2025 have been considered by the examiner.
Claim Objections
Claims 45-62 are objected to because of the following informalities:
Re claim 45, substitute “The device” with -- The speculum -- (see line 1).
Re claim 46, substitute “The device” with -- The speculum -- (see line 1).
Re claim 47, substitute “The device” with -- The speculum -- (see line 1).
Re claim 48, substitute “The device” with -- The speculum -- (see line 1).
Re claim 49, substitute “The device” with -- The speculum -- (see line 1).
Re claim 50, substitute “The device” with -- The speculum -- (see line 1).
Re claim 51, substitute “The device” with -- The speculum -- (see line 1).
Re claim 52, substitute “The device” with -- The speculum -- (see line 1).
Re claim 53, substitute “The device” with -- The speculum -- (see line 1).
Re claim 54, substitute “The device” with -- The speculum -- (see line 1).
Re claim 55, substitute “The device” with -- The speculum -- (see line 1).
Re claim 56, substitute “The device” with -- The speculum -- (see line 1).
Re claim 57, substitute “The device” with -- The speculum -- (see line 1).
Re claim 58, substitute “The device” with -- The speculum -- (see line 1).
Re claim 59, substitute “The device” with -- The speculum -- (see line 1).
Re claim 60, substitute “The device” with -- The speculum -- (see line 1).
Re claim 61, substitute “The device” with -- The speculum -- (see line 1).
Re claim 62, substitute “The device” with -- The speculum -- (see line 1).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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) 44-48, 55, and 62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moehring et al. (US 2020/0107813 A1) (“Moehring”), cited by the applicant.
Re claims 44-45, Moehring discloses a speculum operable to be disposed within an ear of a subject, the speculum comprising:
a housing (451) comprising a light conducting element (452) (fig. 4A; paras. [0007], [0092]), wherein a transmitted optical illumination is conducted by total internal reflection via the light conducting element (para. [0007]), wherein the housing has a lumen therewithin (para. [0007]), and wherein the housing is configured to allow a reflected optical illumination to propagate through the lumen (para. [0007]);
one or more coupling portions (454) which couple the transmitted optical illumination from a light source to the light conducting element, wherein the one or more coupling portions are shaped as a conic section (fig. 4A; paras. [0092]-[0093]); and;
an insert, wherein the insert is configured to be mechanically coupled to the housing (para. [0096] – “A speculum may comprise an inner shell on an inner side of the housing. An inner shell may comprise a shield. A shield may prevent an ultrasound signal from a transducer from being transmitted outside of the speculum.”).
Re claim 46, Moehring further discloses wherein the insert comprises a lens (422) (para. [0095]), an ultrasound transducer (410) (para. [0095]), one or more electrical leads (516) electrically coupled to the ultrasound transducer (para. [0109]), one or more wires electrically coupled to the one or more electrical leads and the ultrasound transducer, or any combination thereof (para. [0116]).
Re claim 47, Moehring further discloses wherein the ultrasound transducer comprises a capacitive micromachined ultrasonic transducer (para. [0076]).
Re claim 48, Moehring further discloses wherein the ultrasound transducer is electrically coupled to the one or more electric leads of the insert by the one or more wires (paras. [0095]-[0096], [0113]).
Re claim 55, Moehring further discloses wherein the light conducting element comprises an ellipsoid shape (para. [0114]).
Re claim 62, Moehring further discloses wherein the housing and the one or more coupling portions are portions of a speculum, wherein the speculum is operably and releasably coupled to an otoscope (paras. [0010], [0024]-[0025]).
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.
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) 59-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moehring in view of Shelton et al. (US 2018/0125346 A1) (“Shelton”), cited by the applicant. The teachings of Moehring have been discussed above.
Re claims 59-60, Moehring fails to specifically teach wherein the housing comprises a proximal sealing member, a distal sealing member, or any combination thereof; and wherein the proximal sealing member and the distal sealing member comprise an elastomeric material configured to seal the housing within the ear of the subject (fig. 6A, para. [0063]).
Shelton discloses an otoscope including housing, wherein the housing comprises a proximal sealing member, a distal sealing member, or any combination thereof; and wherein the proximal sealing member and the distal sealing member comprise an elastomeric material configured to seal the housing within the ear of the subject (paras. [0102], [0107]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the teachings of Moehring and Shelton in order to improve examinations of a subject’s ear.
Claim(s) 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moehring.
Moehring discloses the claimed invention except for wherein the housing is partially or wholly vapor polished, aluminum coated, chrome coated, or any combination thereof.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to form a housing that is partially or wholly vapor polished, aluminum coated, chrome coated, or any combination thereof, since it has bene held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moehring in view of Goldfain (US 2015/0133732 A1), cited by the applicant. The teachings of Moehring have been discussed above.
Moehring discloses a method of using an otoscope, the method comprising:
directing optical illumination of a light source to one or more coupling portions (para. [0092]), wherein the one or more coupling portions are shaped as a conic section (para. [0092]); directing the optical illumination from the one or more coupling portions to a light conducting element (para. [0092]), wherein the optical illumination propagates through the light conducting element by total internal reflection (para. [0007]); and
collecting reflected optical illumination from a target within a lumen of a housing (para. [0007]), wherein the housing comprises a portion of a speculum of an otoscope (para. [0025]).
Moehring fails to teach collimating the optical illumination using the one or more coupling portions.
Goldfain discloses an otoscope and the method using the otoscope, wherein the method includes collimating the optical illumination using the one or more coupling portions (25, 204) (fig. 2, para. [0031]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to combine the teachings of Moehring and Goldfain in order to improve examinations of a subject’s ear.
Allowable Subject Matter
Claims 49-54 and 56-58 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record, taken alone or in combination, fails to teach, the features of claims 49-54 and 56-58.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Priest et al. (US 5,658,235)
Coon et al. (US 11,147,441)
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/APRIL A TAYLOR/Examiner, Art Unit 2876
/THIEN M LE/Primary Examiner, Art Unit 2876