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 .
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 81, 83-91, and 94-102 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 20190142258 A1) in view of Ruppersberg (US 20150351607 A1).
For claim(s) 81 and 91, Shelton teaches
A speculum [500] operable to be disposed within an ear of a subject, the speculum comprising:
a housing [502, 510] comprising a lumen [520, 530] configured to allow a pressure challenge wave to be propagated therethrough,
wherein the housing comprises a distal end [502] sized and shaped to be disposed within an external auditory meatus of a subject;
and a seal [560] comprising a surface sized and shaped to interface with the external auditory meatus,
wherein the seal comprises a compressible member [550, 562] deformable to interface with the external auditory meatus,
and wherein the seal is configured to retain a volume of fluid within the lumen of a speculum of an otoscope in response to one or more of a negative pressure change or a positive pressure change. [¶¶63-64]
Shelton fails to teach the seal comprising silicone.
Ruppersberg teaches an otoscope [Fig(s). 5] with a sealing element [14] comprising silicone. [¶129 ¶221]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the seal of Shelton to be formed with silicone as taught by Ruppersberg in order to ensure patient comfort and material performance. As motivated by Ruppersberg ¶129 ¶221.
For claim(s) 83 and 93, Shelton teaches
wherein the plurality of compressible flanges comprises monotonically decreasing diameters. [Fig. 6]
For claim(s) 84 and 94, Shelton teaches
wherein the volume is disposed on a proximal side of the compressible member. [¶76, Fig. 6]
For claim(s) 85 and 95, Shelton teaches
wherein the volume is disposed on a distal side of the compressible member. [¶76, Fig. 6]
For claim(s) 86-88 and 96-98, Shelton teaches the speculum is releasably coupleable to an otoscope with an ultrasound transducer comprising an indication that a pressure wave is retained in the lumen. [speculum summarized in ¶7 can be coupled for otoscopy (i.e., capable of coupling to the otoscope recited in claim(s) 86-88)]
For claim(s) 89 and 99, Shelton teaches
wherein a most distal of the one or more compressible members comprises a setback of greater than about 2 mm. [¶63]
For claim(s) 90 and 100, Shelton teaches
wherein a most distal of the one or more compressible members is configured to allow the speculum to enter at least about 5 mm within the external auditory meatus. [¶84]
For claim(s) 101-102, Shelton teaches
the compressible member comprises a gel within a volume in an interior portion of the compressible member. [¶76]
Claim(s) 82 and 92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shelton in view of Ruppersberg and Gilad (US 20180000336 A1).
For claim(s) 82 and 92, Shelton fails to teach the seal being a material with a Shore durometer between 40-80 Shore-alpha. However, consider that Shelton does teach in ¶76 that the seal being made of any one or more of a variety of materials including materials with a variety of resiliencies to achieve a seal and ensure durability.
Gilad teaches an otoscopic speculum with a shore durometer including values from about 40-80 shore alpha. [¶50, ¶110]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the seal of Shelton to be formed with the shore durometer values of Gilad in order to ensure the seal aligns with the anatomy of the ear canal. As motivated by Gilad ¶50.
Response to Arguments
Applicant’s arguments with respect to the prior art have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
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).
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/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791
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