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 .
Corrected Final Office Action
This is to provide a corrected final office action to the amendments filed 12/5/2025. The previously mailed office action (2/5/2026), while rejected as a final rejection, was inadvertently labeled as a non-final rejection in the heading and is being withdrawn.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the previous combination of reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Claim 1 has been modified from canceled claim 4 to specify the cap being “hemispherical” in shape. In view of the amendment, an updated search was conducted resulting in the modified 103 Rejection set forth below.
Applicant argues “the hemispherical rounded end could reduce insertion trauma of the human cochlea…feature not taught in Stankovic…” (Pages 1 and 2 of Remarks). Claim 1 does not make any reference to the cochlea or the need to reduce trauma while insertion of the probe into the cochlea. Under broadest reasonable interpretation, the claim language is directed to an imaging tool with components that are typically common for an optical imaging based probe.
Claim 23 makes reference to “the cochlea” and is dependent on claim 1. Since claim 1 does not recite “insertion of the imaging tool into an anatomical region such as the human cochlea”, it is suggested claim 1 be modified to include insertion of the probe into an anatomical region such as the cochlea and specify the depth of insertion into the cochlea by the hemispherical cap tip at the distal end of the imaging tool.
In view of lack of additional specific arguments with respect to the remaining references, the rejections are maintained.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 23 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23 recites the limitation "tool can be inserted to a depth of at least 25 mm into the cochlea" in line 4. Claim 23 is modified to be dependent on claim 1 and claim 1 makes no mention of a specific anatomical body part, specifically the probe being adapted to be inserted into an anatomical region such as the human cochlea. There is insufficient antecedent basis for this limitation in the claim. It is suggested claim 1 language be modified to include the use of the imaging tool with respect to the cochlea and depth of insertion of the tool to reduce insertion trauma of the human cochlea (as set forth in the Remarks).
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) 1-7, 9-11, 16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strankovic et al. (2019/0029570) in view of Hatzilias et al. (2015/0035943).
With respect to claim 1, 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] but does not explicitly teach of a hemispherical cap coupled to the distal end of the sheath. In a related field of endeavor Hatzilias et al. teach of an ear probe 106 with light source 116, optical element 118 and a cap 127 mounted or coupled on the tip of the probe or to the distal end of the sheath [0086] that is hemispherical in shape (fig. 17A, 22). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Hatzilias et al. to modify Strankovic et al. to provide a tip that is shaped to conform to the contour of the ear canal and reduce discomfort and be able to effectively navigate the ear canal to generate a model of the ear canal using the determined geometry of the ear canal [Hatzilias, 0009, 0010].
With respect to claim 5, Strankovic et al. in view of Hatzilias et al. teach of a rotary junction [0062] coupled to the proximal end of the waveguide 406 and the proximal end of the driveshaft 404 wherein the waveguide 406 and the optical probe head 402 are rotatably disposed within the flexible sheath 418 [0062, 0068].
With respect to claim 6, Strankovic et al. in view of Hatzilias et al. teach of the probe head to comprise a spacer 408 at the proximal end wherein the distal end of the waveguide is coupled to the proximal end of the spacer 408 [0064, 0065, 0069].
With respect to claims 7 and 9-11, Strankovic et al. in view of Hatzilias et al. teach of the spacer 408 to comprise a conical shape such as the prism 412 having a narrow proximal end adjacent the waveguide 406 and a reflector to reflect light from the waveguide 406 away from a central axis of the waveguide [0066]. 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].
With respect to claim 16, Strankovic et al. in view of Hatzilias et al. teach of the optical waveguide to comprise a single mode fiber 402 [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].
With respect to claim 18, Strankovic et al. in view of Hatzilias et al. teach of the probe head to have a length of about 1. 5 mm or longer [0069] and therefore under broadest reasonable interpretation, reads on the claimed length of 1.7 mm, as there is variability to the length range.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strankovic et al. in view of in view of Hatzilias 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].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strankovic et al. in view of in view of Hatzilias et al. and further in view of Halperin et al. (2003/0199755). Strankovic et al. do not explicitly teach of a low friction sheath. In a related field of endeavor Halperin et al. teach of a catheter assembly that includes a low friction sheath [0040] which may be incorporated relative to the flexible sheath (as set forth by Strankovic reference). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Halperin et al. to modify the previous references to provide for an improved system and method for guiding and/or providing visualization during procedures [Halperin, 0021].
Claim(s) 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strankovic et al. in view of in view of Hatzilias et al. and further in view of Simaan et al. (2011/0066160). Strankovic et al. teach of the sheath and optical probe head with length of about 1.5 mm and therefore reads on the claimed length of 1.7, as there is variability to the length range [0069], defining the maximum rigid length of the imaging and the distal portion of the imaging took can be inserted into a curved sample having a radius of curvature of at least 2 mm (fig. 3). Strankovic et al. do not explicitly teach of the sheath diameter specific range and the depth of insertion into the cochlear and teach of the optical probe to have a relatively small diameter on the order of microns to a few millimeters [0048] but do not teach of the specific diameter. In a related field of endeavor Simaan et al. teach of a probe for insertion of cochlear implants where the depth of insertion is about 27 mm [0108]. Simaan et al. also teach of the sheath having a diameter of 0.6 mm or 600 µm diameter of the tip [0170]. Strankovic et al. teach of the distal portion of the imaging tool to comprise of at least a portion or bare portion of the optical waveguide, probe head, and sheath (claim 1). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Simaan et al. to modify the previous references to ensure optimal depth of insertion of the probe for increased safety and accuracy [Simaan, 0114, 0115].
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Strankovic et al. in view of in view of Hatzilias et al. and further in view of Chou et al. (2021/0212707). Strankovic et al. do not explicitly teach of the claimed bending stiffness range. In a related field of endeavor Chou et al. teach of a catheter system where the distal portion has a bending stiffness in the range between 0.0225-0.225 Nmm2 [0138]. The claimed range of 7.58 * 10-8Nm2 is converted to 0.0758 Nmm2 and therefore the disclosed range 0.0225-0.225 Nmm2 falls in the claimed range. Chou et al. also teach of a flexural stiffness in the range of 0.05-0.5 Nmm2 which also is supported by the claimed range of being less than 7.58 * 10-8Nm2. Therefore, under broadest reasonable interpretation, the Chou reference teaches of the bending stiffness of the tool to fall in the claimed range. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Chou et al. to modify the previous references to provide desired flexibility to the distal end to effectively navigate and reach the angular bends with respect to navigating the anatomical targets [Chou, 0139].
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).
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