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 .
Status of Application
Applicant’s notice of appeal and pre-appeal brief conference request filed 9 March 2026 is on record and has been reviewed. The conclusion of the panel is to re-open prosecution with a corrected rejection of claims 10 and 26, as seen below.
Response to Arguments
Applicant’s arguments, filed 9 March 2026, with respect to the rejections of the pending claims, as amended, under 35 USC 102 and 103 have been fully considered and are partially persuasive.
Applicant argues that there is no motivation to combine Bruce and Hill. Applicant submits that Bruce teaches an ear implant with flanges and Hill teaches the use of a translucent material to visualize obstructions, alleging that the translucent material is intentionally colorless. However “translucent” does not necessarily mean colorless. Translucence occurs when light passes through a material with varying refractive indices, for example, stained glass. The recitation of translucency does not preclude the addition of a pigment.
Applicant argues that Cohan is nonanalagous to Bruce as well as the instantly claimed invention. The Examiner agrees that a periodontal probe is not in the same field of endeavor as ear tubes. However, Hill teaches the use of color in ear tubes in order to verify proper placement. When Applicant claims multiple colors and lengths of visual elements as measurement tools, it is within the skill of a worker in the art to consider other measurement tools. In the instant case, Cohan discloses a tool with a claimed color combination and a length of a visual element as a measurement tool, and is appropriately combined with Hill’s ear tube to arrive at the claimed invention.
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.
Claims 1-4, 11, 12, 14, 21, 23-25, and 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,695,275 to Bruce et al in view of US 2003/0018291 to Hill et al.
In the specification and figures, Bruce suggests the invention substantially as claimed by Applicant. With regard to claims 1-4, 14, 21, 23-25, and 30, Bruce teaches a T-shaped ear tube with a first end 12 with a flange 14 (1st visual element) and a tab 15 (3rd visual element) and a second end 13 with a flange 16 (2nd visual element) and a shaft 10 with a lumen 11 connecting the ends, wherein the tube is a single unitary piece of silicone (see FIG 1 and accompanying text, claim 11, column 1, lines 56-60). Bruce teaches different visual elements at each end, but does not teach that the visual elements comprise a color.
However, Hill discloses an ear tube with a first element translucent stem 10, and a second element arms 22, and a third element transparent collar 50 wherein the arms comprise a color that is visually distinguishable from the translucent stem and transparent collar in order to allow the physician to see the positioning of the arms through the tympanic membrane (see ¶0010, 0029, 0037). It would have been obvious to a person having ordinary skill in the art at the time of filing to provide the ear tube as disclosed by Bruce with a contrasting color scheme, as disclosed by Hill, in order for the physician to visualize the tube placement, as taught by Hill.
With regard to claims 11, 28, Bruce discloses that the distance from flange to flange is 2-3mm, near the range claimed by Applicant (see column 3, lines 20-30). It has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(B).
Claims 10 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,695,275 to Bruce et al in view of US 2003/0018291 to Hill et al., further in view of US 2005/075703 to Hunter et al.
In the specification and figures, the prior art suggests the apparatus substantially as claimed by Applicant. With regard to claims 10 and 26, the prior art does not teach a reflective of fluorescent additive. However, Hunter teaches polymer compositions that may be used in ear stents (see ¶1341, 1349), wherein the polymer may comprise fluorescent materials to be visualized under fluorescent light (see ¶0970). It would have been obvious to a person having ordinary skill in the art at the time of filing to add fluorescent materials as disclosed by Hunter to the ear tube suggested by Bruce and Cohan in order to visualize the implant under fluorescent light, as taught by Hunter.
Claims 12, 29, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over US 4,695,275 to Bruce et al in view of US 2003/0018291 to Hill et al, further in view of US 3,935,640 to Cohan.
In the specification and figures, the cited prior art suggests the apparatus substantially as claimed (see rejections above). With regard to claims 12 and 29, Hill discloses that the color of the first visual element (stem) is visually distinguishable from the second visible element (arms, see above), but does not disclose the claimed color schemes. However, Cohan discloses a tool for measuring depth of insertion comprising a green-yellow-red color scheme with specific lengths in order to measure how far the tool is deployed into patient tissue (see at least column 2, line 56 to column 3, line 4). It would have been obvious to a person having ordinary skill in the art at the time of filing to add the colors and prescribed length markings as disclosed by Cohan to the ear tube suggested by the cited prior art in order to provide a visual indicator of the location of the tool within patient tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799
4 May 2026
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