DETAILED ACTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) for failure to particularly point out and distinctly claim the subject matter applicant regards as the invention.
Regarding claim 1, applicant claims an ear system for testing prothesis which comprises a detector on an outer wall of a closed cavity or an inner wall of the closed cavity. This appears consistent with figures 6a and 6b of applicant’s description. However, it then goes on to describe wherein the pressure probe comprises a hydrophone within the closed cavity on the inner surface. It is not clear whether this is a further addition to the pressure probe that has been described as on the outside wall (an embodiment not described in the specification), or if this is a further description of the pressure probe disposed inside the wall. Correction or clarification of this issue is required. Claim 2 suffers the same problem. It is not clear whether this is an attempt to claim the embodiment of fog. 6b (i.e. with the pressure sensor on the outside of the cavity) or if this is claiming a combination of such a pressure sensor with the hydrophone embodiment of fig. 6a, which is not supported by applicant’s specification. The remaining claims are rejected as they inherit this issue.
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, 5, 7, and 9, are rejected under 35 U.S.C. 103 as being unpatentable over Stefanini et al. (WO 2016/097990) in view of Galibois et al. (US 2015/0004584).
Regarding claims 1, 5, Stefanini discloses in fig. 1 a physical ear model (page 2:30 – page 3:11 and fig. 1), Stefanini discloses a first portion simulating a middle ear - see fig. 3, and note that to be consistent with applicant’s claims, the first portion is the collar section 14c of fig. 3, which is between the two chambers 14 and 16, and contains the prothesis P. This section is self-contained between two membranes of sections 14 and 16 and is described in detail in page 6: 12-22. Above this collar section in fig. 2 is part of the outer ear simulation 14 (as per claim 5, and described in page 5: 18-19). Stefanini discloses a second portion with a liquid filled chamber (fig. 3 label 16 and page 5:29 – page 6:3), and a hydrophone mounted on the inner side of this liquid filled chamber (fig. 3 label 16b and also page 6:33 – page 7:2). Stefanini discloses wherein the signal is sent to a device for analysis in page 5: 4-10.
There is no explicit mention of a line through the wall of chamber 16 to access the microphone. However, using lines through walls into sealed chambers is well-established in the medical modeling art, as is disclosed by the system of Galibois in paragraph 0025. It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing, to consider such with the Stefanini system, in order to effectively acquire the desired data.
Regarding claim 7, Stefanini discloses wherein the system components mimic the actual mechanical acoustical properties of an ear (i.e. and its parts, such as those claimed by applicant). See page 7: 28-29.
Regarding claim 9, Stefanini discloses a simulation of the round window in page 6: 4-6.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Steffanini et al. (WO 2016/097990) in view of Galibois et al. (US 2015/0004584) and Nemirovski (US 2002/0143242).
Regarding claims 3 and 4, Stefanini discloses wherein the hydrophone is to be miniaturized in page 7: 1--2. The dimensions are not mentioned. However, similar applications use microphones of about the same size as applicant claims, so as to simulate the acoustical properties of the ear, as described by the ear microphone system of Nemirovsi in paragraph 0076. It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing, to consider these general dimensions with the Stefanini system, so as to accurately model the human ear components.
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Steffanini et al. (WO 2016/097990) in view of Galibois et al. (US 2015/0004584) and also Alexander et al. (US 2004/0076940).
Regarding claim 6, Stefanini does not disclose a flange system to connect the sections. However, this is an established method for linking elements, as is disclosed by the medical modelling system of Alexander in paragraph 0060. It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing, to consider such with the elements of Stefanini, so as to keep them secured as desired.
Claims 10, 12, and 14, are rejected under 35 U.S.C. 103 as being unpatentable over Steffanini et al. (WO 2016/097990) in view of Galibois et al. (US 2015/0004584) and also Dunham (US 2022/0139265).
Regarding claims 10, 12, and 14, Stefanini discloses wherein the model is based upon acoustical properties of static and dynamic parts of the human ear (page 7: 28-29), and wherein the system provides an optical (i.e. graphical) evaluation of the transmission behavior of the inserted prothesis in the human speech frequency range (page 8: 7-18), but does not disclose deriving anatomical data from CT scans, or wherein systems are created by 3D printing. However, these are common technique in the medical modeling art, as is disclosed by the modeling system of Dunham in paragraphs 0102-0104. It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing, to consider this concept with the Stefanini system, in order to provide an accurate model.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Steffanini et al. (WO 2016/097990) in view of Galibois et al. (US 2015/0004584) and also Buras et al (US 2023/0147689).
Regarding claim 11, Stefanini discloses analysis of the simulated transmission and parameter data in page 8: 7-18. There is no mention of AI refinement. However, this concept is established with regard to data analysis, as is disclosed by the training system of Buras in paragraph 0015. It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to consider such with the Stefanini system, in order to provide optimization.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Steffanini et al. (WO 2016/097990) in view of Galibois et al. (US 2015/0004584) and also Burrow (US 2021/0381813).
Regarding claim 13, Stefanini does not disclose the manner in which the liquid tight chamber is filled. However, UV radiation is a long-established method for sealing a chamber, as is disclosed by the system of Burrow in paragraph 0095. It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to consider such with the Stefanini system, in order to effectively seal the chamber.
Remarks
Claims 2 and 8 do not have prior art rejections, but are rejected under 35 U.S.C. 112(b) as described above. Once the 112 issue is resolved, these claims will likely be considered allowable.
Conclusion
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TIMOTHY A. MUSSELMAN
Primary Examiner
Art Unit 3715
/TIMOTHY A MUSSELMAN/Primary Examiner, Art Unit 3715
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