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 .
Response to Arguments
Applicant's arguments filed 6/11/2026 have been fully considered but they are not persuasive. Applicant argues that the Neev reference does not describe the tapered shape in the text and that the representation in the figure is schematic where the “individual parts cannot be taken to be literal representations of the actual components”. While the exact shape is not disclosed in the text, the figures represent the overall connection and orientation of the components of the cochlear coupler probe 127 and under broadest reasonable interpretation of the figure 1, the spacer 120 clearly has a distinct and narrow ending or shape relative to the optical coupler 125. It is well known in the art for the spacers or coupling sections connected to optical waveguides and fibers in micro-optical imaging systems are typically tapered at the end. The claim language does not provide any further structure to the spacer beyond a “tapered shape having a narrow proximal end” which is coupled to the distal end of the optical waveguide. Under broadest reasonable interpretation of figure 1, the spacer has a tapered shape at the tip which is coupled to the distal end of optical waveguide.
“FIG. 5(A) shows an exploded-view diagram of the optical probe head which depicts (from left/proximal to right/distal) the relative positions of the single mode fiber (SMF), multi-mode fiber (MMF), spacer, GRIN lens (which is inserted into a distal end of the spacer), a reflector prism, and a reflector cap (which houses the reflector prism and attaches to the distal end of the spacer). The spacer may include a cylindrical neck region at its proximal end and a cylindrical distal portion, where the neck region has a smaller diameter than the distal portion, and wherein the two cylindrical portions are joined by a tapered region therebetween. The SMF is inserted into a proximal end of the spacer, in the proximal portion of the narrow neck region, while the MMF is inserted further into the narrow neck region of the spacer, adjacent to a distal end of the SMF (see FIG. 3)” [0031, present application].
As per the specification (above paragraph), the spacer is disclosed to include a “cylindrical neck region at its proximal end and a cylindrical distal portion where the neck region has a smaller diameter than the distal portion” where the “MMF is inserted into the narrow neck region of the spacer adjacent to distal end of the SMF”. The present claim language with respect to a “tapered shape having narrow proximal end” is quite broad and does not adequately define figure 5 and the corresponding text sections. The Neev reference does not disclose the particular arrangement as disclosed in figure 5 and paragraph [0031] of present application. Therefore, it is suggested claim 7 be modified to further define the spacer as set forth in the above underlined section.
Other Relevant Prior Art (with respect to spacers):
Paschalis (2020/0379189) (previously cited): Discloses spacers 303a with a tapered shape having a narrow proximal end and coupled to distal end of optical waveguide (fig. 3).
For these reasons, the 103 Rejection is maintained and repeated below.
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.
Claim(s) 7, 9-11, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neev (2013/0046357) in view of Stankovic et al. (2019/0029570) and further in view of Bergman et al. (2012/0281071).
With respect to claim 7, Neev teaches of a system and method for imaging and treatment of disorders including hearing impairment where 3-dimensional imaging of the cochlear surface 205 and layers below the cochlear surface 207 are provided [0021]. Neev teaches of an external member such as a flexible endoscope or other larger diameter cover or sheath [0022] that includes a portion of the optical waveguide or optical fiber 110 or 290 or 320 or 415 with a proximal and distal end and the distal end of the fiber or waveguide is disposed within the endoscope or cover (fig. 1-4). Neev teaches of the optical probe head (fig. 1) to be coupled to the distal end of the optical fiber/waveguide wherein the optical probe head comprises a spacer 120 at a proximal end and the spacer comprises a tapered shape having a narrow proximal end and the distal end of the optical waveguide 110 is coupled to the proximal end of the spacer 120 (see figure below with tapered shape of spacer 120 coupled to the distal end of optical waveguide 110, fig. 1, [0020]).
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Neev does not explicitly teach of the lubricant disposed within the flexible sheath. Neev teaches of imaging of the cochlea at various lengths [0023] but does not explicitly teach of the depth of at least 1 mm. In a similar field of endeavor Strankovic et al. teach of an imaging tool 400 comprising a drive shaft 404 including a proximal end 112 and distal end (114, 402) [0051, 0069, fig. 4], an optical waveguide 106, 406 including a proximal 112 and distal 114 end [0049-0051, 0063, 0064], where the proximal end 112 of the waveguide 106 being disposed within the proximal end of the drive shaft and the distal end 114 of the waveguide 106 extending beyond the distal end of the drive shaft (fig. 1, 0051], and an optical probe head 104 coupled to the distal end of the waveguide 106 [0050]. Strankovic et al. teach of a distal end of the waveguide 406 extending beyond the distal end of the drive shaft 404 comprising a bare portion of the waveguide 406 (fig. 4, 0062), with a lubricant such as hyaluronic acid or glycerol disposed within the flexible sheath [0062]. Strankovic et al. also teach of inserting the probe to a depth of a few millimeters [0048]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Strankovic et al. to modify Neev to more effectively resolve micro sized anatomical features within the cochlea for better diagnostics [Stankovic, 0006, 0007].
With respect to claims 7 and 9-11, Strankovic et al. teach of a reflector cap or sleeve 414 at the distal end with the reflector disposed inside the cap or sleeve 414 [0066-0068] and the sleeve 414 comprises an optical reflective surface formed therein with the prism 412 redirecting light emitted by lens 410 [0066]. But the previous references do not explicitly teach of a hemispherical cap coupled to the distal end of the sheath or a reflector cap at the distal end. In a similar field of endeavor Bergman et al. teach of an optical scanning device for scanning of the ear canal that includes a probe 34 [0032, 0033] where the distal end of the probe is coupled to a hemispherical or dome cap 56 that includes a reflector 48 to reflect light or a reflector cap at the distal end with the reflector disposed within the cap 56 [0034, fig. 3, 4]. Therefore, the reflector cap 56 with reflector 48 comprises an optically reflective surface formed therein. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Bergman et al. to modify the previous teachings to maintain optimal fixed distance with respect to the tissue surface and prevents damage to delicate tissues and accurately measure biological structures.
With respect to claim 16, Neev in view of Strankovic et al. in view of Bergman et al. teach of the optical waveguide to comprise a single mode fiber 110 [Neev, 0020, and fiber 402 Strankovic, 0059] wherein the narrow proximal end of the spacer 408 comprises a multimode fiber disposed therein adjacent to the distal end of the waveguide [0014, 0063].
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Neev in view of Strankovic et al. in view of in view of Bergman et al. and further in view of Casscells, III et al. (2003/0171691). Strankovic et al. teach of a reflector cap or sleeve 414 at the distal end with the reflector disposed inside the cap or sleeve 414 [0066-0068] and the sleeve 414 comprises an optical reflective surface formed therein with the prism 412 redirecting light emitted by lens 410 [0066]. Strankovic et al. do not teach of the prism comprising a reflective coating comprising gold. In a similar field of endeavor Casscells, III et al. teach of a catheter assembly that include a reflector at the tip with a prism comprising reflecting material such as gold [0176]. Strankovic et al. teach of a reflective coating such as a metallic coating [0014, 0058] but do not explicitly teach of a glass material. Casscells, III et al. teach of the use of glass fibers [0176]. Strankovic et al. teach of a GRIN lens 410 disposed within the distal end of the spacer 408 adjacent to the prism 412 [0069, 0070, 0073]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Casscells, III et al. to modify the previous references to use suitable reflector that includes highly IR-reflecting material and effective measure vessel temperatures and differences between regions and identify unstable plaques and better diagnostics [Casscells, 0029].
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: In view of the amendments, claims 1, 5, 6, 18, 21, 23-26, and 34 are allowed. The combined prior art of record does not teach or render obvious an imaging tool comprising:
“a drive shaft including a proximal end and a distal end;
an optical waveguide including a proximal end and a distal end,
the proximal end of the optical waveguide being disposed within the proximal end of the drive shaft, and
the distal end of the optical waveguide extending beyond the distal end of the drive shaft, such that a portion of the optical waveguide is disposed within a flexible sheath and not disposed within the drive shaft;
wherein a lubricant is disposed within the flexible sheath, and
wherein a hemispherical cap is coupled to a distal end of the flexible sheath; and an optical probe head coupled to the distal end of the optical waveguide,
wherein a distal portion of the imaging tool is configured to be inserted into a cochlea to a depth of at least 25 mm”.
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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BR
/BAISAKHI ROY/ Primary Examiner, Art Unit 3797
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