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 .
Specification
Amendment to the specification filed 2/18/26 is entered.
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) 1-2, 4-7, 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feng (CN203777146 U) in view of Monroe et al. (US Patent No. 5919130).
Regarding Claim 1, Feng discloses an otoscope comprising: a body comprising a speculum receiving portion at a first end of said body (see below); an ENT speculum (2) connectable to the speculum receiving portion (Fig. 3), the speculum (2) comprising a longitudinal axis (see below) along which is arranged: a tapered distal portion (see below) having a tool access bore (see below) therethrough, a proximal portion (see below) comprising a connector and having a proximal aperture(fitting around receiving portion of body in Fig. 3) therethrough, and an intermediate portion (see below) intermediate the distal portion and the proximal portion (see below), the distal, intermediate and proximal portions being arranged axially along said longitudinal axis (fig. 1), wherein said proximal aperture and tool access bore are aligned such that they form a first viewing passage (see below), and said otoscope further comprising: an optical output (4) connected to a second end of the body, comprising a viewing aperture which forms a second viewing passage (see below); a handle (7) attachable to the body and comprising a light emitter(6+8+10, Fig. 3 [0013]); wherein said intermediate portion (see below) comprises a tool entry aperture (“passage” 1) through which an ENT tool can access the tool access bore without passing through said proximal aperture in the connector [0014]; wherein the proximal portion of the speculum attaches to the speculum receiving portion such that the first and second viewing passages are aligned (shown below).
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Feng is silent to the first end of the body comprising one or more optics (e.g. lenses).
Monroe discloses an otoscope in the same field of endeavor which comprises an otoscope body (28, fig. 14) with specula (74) attached. The tip of the otoscope received in the specula(74) includes a lens (40) to focus an image of the target (col. 9; ln. 25-57). It would have been obvious to one having ordinary skill in the art before the effective filing date to include a lens within the first end of the body of Feng as taught by Monroe in order to focus the image of the target.
Regarding Claim 2, said tool entry aperture(“passage” 1 of Feng) is configured such that an ENT tool can access the tool access bore at an angle incident to said longitudinal axis (tool can come at an angle and intersect the longitudinal axis through the passage).
Regarding Claim 4, said tool entry aperture is formed as a cut-away portion of the intermediate portion (fig. 2 , Feng).
Regarding Claim 5, said connector is a threaded connector, (see Feng translation of [0014], “the speculum 2 end in a projecting thread, 3 is provided with a corresponding screw thread in speculum 2, in endoscopic device 2 and 3 through screw thread connection”).
Regarding Claim 6, the proximal portion of the speculum (2) comprises radially outwardly protruding protrusions (see Feng figures below).
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Regarding Claim 7, the speculum (2) is single-use (the speculum, regardless of material, is fully capable of being discarded after a single use).
Regarding Claim 9, the distal, intermediate and proximal portions are formed from a single piece of material (shown as single piece in Feng Fig. 1-2).
Regarding Claim 10, the device of Feng in view of Monroe is described in the rejection of claim 1 above. However, Feng is silent to wherein the distal portion is removable from the intermediate and proximal portions. However, it would have been obvious to one having ordinary skill in the art to make the speculum in a variety of pieces such that the distal portion would be removable in order to have interchangeability of the distal portion to adjust the length of the speculum or tip material. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961)
Regarding Claim 11, the optical output (4, Feng) comprises an eyepiece (“observing magnifier” [0005]).
Regarding Claim 12, (as best understood) the eyepiece comprises one or more magnification lenses or optics (described as a magnifier by Feng, see [0005, 0014]).
Claim(s) 13 s/are rejected under 35 U.S.C. 103 as being unpatentable over Feng (CN203777146 U) in view of Monroe et al. (US Patent No. 5919130) in further view of Perkins et al. (US Patent No. 11096627 B2).
Regarding Claim 13, Feng in view of Monroe discloses the otoscope as described in the rejection of claim 1 above. However, Feng in view of Monroe is silent to a portable electronic device comprising a camera, a display and a camera adapter for attaching the otoscope of claim 1 to the portable electronic device such that the camera is aligned with the second viewing passage.
Perkins discloses an otoscope (160, Fig. 2f-2i, col. 9; ln. 5-21) with viewing device in the same field of endeavor. Perkins teaches attaching a portable electronic device (smart phone) comprising a camera, a display with a camera adapter to an otoscope to align with the viewing window of the otoscope (col. 9; ln. 5-52) in order to be able to use the single otoscope under different operating modes due to the capabilities of the smart phone (col. 1; ln. 15-26).
It would have been obvious to one having ordinary skill in the art before the effective filing date to use a smart phone (having camera and display) with a camera adapter with the otoscope of Feng in view of Monroe as taught by Perkins in order to allow the user to use different operating modes of a smart phone to assist in diagnosing or treating the patient.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feng (CN203777146 U) in view of Monroe et al. (US Patent No. 5919130) in further view of Clark et al. (US Publication No. 2023/0172427 A1).
Regarding Claim 14, Feng discloses an otoscope comprising: a body comprising a speculum receiving portion at a first end of said body (see below); an ENT speculum (2) connectable to the speculum receiving portion (Fig. 3), the speculum (2) comprising a longitudinal axis (see below) along which is arranged: a tapered distal portion (see below) having a tool access bore (see below) therethrough, a proximal portion (see below) comprising a connector and having a proximal aperture(fitting around receiving portion of body in Fig. 3) therethrough, and an intermediate portion (see below) intermediate the distal portion and the proximal portion (see below), the distal, intermediate and proximal portions being arranged axially along said longitudinal axis (fig. 1), wherein said proximal aperture and tool access bore are aligned such that they form a first viewing passage (see below), and said otoscope further comprising: an optical output (4) connected to a second end of the body, comprising a viewing aperture which forms a second viewing passage (see below); a handle (7) attachable to the body and comprising a light emitter(6+8+10, Fig. 3 [0013]); wherein said intermediate portion (see below) comprises a tool entry aperture (“passage” 1) through which an ENT tool can access the tool access bore without passing through said proximal aperture in the connector [0014]; wherein the proximal portion of the speculum attaches to the speculum receiving portion such that the first and second viewing passages are aligned (shown below); wherein when the handle (7) is connected to the body, light produced by the light emitter (6+8+10) is directed down the speculum towards the tool access bore.
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Feng is silent to the first end of the body comprising one or more optics (e.g. lenses).
Monroe discloses an otoscope in the same field of endeavor which comprises an otoscope body (28, fig. 14) with specula (74) attached. The tip of the otoscope received in the specula(74) includes a lens (40) to focus an image of the target (col. 9; ln. 25-57). It would have been obvious to one having ordinary skill in the art before the effective filing date to include a lens within the first end of the body of Feng as taught by Monroe in order to focus the image of the target. By having optics at the end of the body, the light from the light emitter would pass through the optics before reaching the tool access bore.
Feng in view of Monroe is silent to the components being provided in a kit.
Clark disclose otoscope devices in the same field of endeavor. Clark disclose providing the otoscope devices and specula in a kit along with other components and spare parts [0054]. It would have been obvious to one having ordinary skill in the art before the effective filing date to provide the components of the device of Feng in view of Monroe in a kit as taught by Clark in order to supply all necessary components together to the end user.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feng (CN203777146 U) in view of Monroe et al. (US Patent No. 5919130) in further view of Baker et al. (US Publication No. 2014/0039262 A1).
Regarding Claim 3, the device of Feng in view of Monroe is described in the rejection of claim 1 above. However, Feng is silent to the dimensions of the specula, in particular wherein said intermediate portion is between 20mm and 50mm (2-5 cm) in length.
Baker discloses an otoscope speculum in the same field of endeavor. Baker discloses that the length of the speculum body is 2-5 cm [0024]. It would have been obvious to one having ordinary skill in the art before the effective filing date to make the body of the speculum 5 cm (50 mm) in length as taught by Baker since this is shown to be a suitable dimension for an otoscope speculum. It would have been obvious to dimension the intermediate portion of Feng to be a dimension which falls within the range of 2-5 cm since this is a major portion of the overall speculum and optimizing the length of the intermediate section would allow the device to optimize fit within a patient’s ear canal . "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feng (CN203777146 U) in view of Monroe et al. (US Patent No. 5919130) in further view of Kwong (US Publication NO. 2020/0178776 A1).
Regarding Claim 8, the device of Feng in view of Monroe is described in the rejection of claim 1 above. However, Feng is silent to the material of the speculum being that such that the speculum is autoclavable.
Kwong discloses an otoscope speculum in the same field of endeavor. Kwong teaches that the speculum may be made from materials which allow it to be autoclaved in order to sterilize the speculum [0059]. It would have been obvious to one having ordinary skill in the art before the effective filing date to make the speculum of Feng in view of Monroe from an autoclavable material as taught by Kwong in order to be able to sanitize the speculum.
Response to Arguments
Applicant's arguments filed 2/18/26 have been fully considered but they are not persuasive.
Argument 1: Applicant argues Feng does not teach a “tool access bore” because the term “bore” requires a continuous, circumferential wall or complete, enclosed, tubular structure.
Response: This is not found persuasive because Applicant’s own disclosure refers to the “tool access bore” as element 106B which is clearly an open-sided channel extending through the tapered distal tip (see figure 1A below). In as much as Applicant has a tool access bore extending through the distal tip, Feng also has the identical structure of a tool access bore extending through the distal tip. Further, Applicant’s definition of bore to require a continuous, circumferential wall is not found in the specification so as to require an interpretation other than broadest reasonable interpretation. Arguing that a bore has to be a closed walled tubular structure is arguing a feature which is not supported by Applicant’s disclosure. A bore is defined by Collins Dictionary as “a hole”. Clearly Feng discloses a hole going through the distal tip.
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Argument 2: It would not have been obvious to modify Feng with Monroe because Monroe’s speculum is sealed and incorporating a tool entry aperture would destroy its essential insufflation capability.
Response 2: This is not found persuasive because this argument mischaracterizes the modification made in the rejection under 35 USC 103. The modification made to claim 1 above is modifying the tip of the body of the otoscope of Feng with an internal lens as taught by Monroe. Monroe is not being modified, rather it is being used to teach a lens at the tip of an otoscope body to focus images. The darkly shaded area in the figure below is the tip of the otoscope body of Feng. This speculum receiving portion or tip is the area which is being modified to include an internal lens for the purpose of focusing images as taught by Monroe.
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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.
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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773