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 .
Terminal Disclaimer
The terminal disclaimer filed on 06/10/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Patent number 12213781 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Examiner notes that the 112(b) rejections are withdrawn in view of the amendments to the claims.
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive. For example, applicant argues “while Le provides ranges of ‘bend radius’ values for the shaft 180 of between 1-10 mm (see e.g. para. 0174), this range is limited to the shaft 180 itself (see Fig. 3) but does not provide any information about the bend radius for a rigid portion of the probe which includes optical components. In rejecting claim 1, the examiner argues that the rigid portion in claim 1 may include as little as a single optical element such as a prism (see Office Action at p. 6). While Le describes several combinations of optical elements which together could have a length of about 1.15 mm (see paras. 0192-0193), Le does not provide any information about the radius of curvature (referred to as ‘bend radius’ in Le) that a probe can achieve when the probe includes a rigid portion in the .75-1.5 mm range.” (REMARKS pg. 8). First examiner notes that applicant’s arguments that the bend radius are limited to the shaft itself is not found persuasive, as [0181] is specifically directed to the stiffness of the probe 1 which may be approximated by summing the stiffness of the catheter sheath and the stifness of the rotating shaft 180, therefore, takes into account other elements with respect to the probe 1 as a whole and [0181] is further specifically directed to the distal end of the probe 1 which would include the rigid portion. Furthermore, examiner notes that applicant’s arguments are directed to features which are not claimed (i.e. a bend radius or radius of curvature for a rigid portion of the probe). In other words, applicant’s arguments appear to be that the bend radius or radius of curvature of the rigid portion is not within the claimed range, however, it is noted that the claim merely recites that the rigid portion of the optical probe is configured to insert into a structure with… a radius of curvature of between 2-6 mm. Examiner notes that the distal end of the probe 1 and/or shaft 180 having a bend radius which may be anywhere from 1 mm – 100 mm provides support that the probe (or distal end thereof) is configured to insert into a corresponding structure with a bend radius (or radius of curvature) of 1 mm-100 mm, where it is noted that since the distal end of the probe is configured to bend with a radius of curvature of 1 mm-100 mm and therefore configured to insert into a structure which may have a radius of curvature of 1 mm – 100 mm, such that the rigid portion is therefore considered to be configured to be inserted into such a structure accordingly. In other words, there is no requirement that the rigid portion has the recited radius of curvature, but rather that the rigid portion is configured to insert into a structure which has a radius of curvature of between 2-6 mm. The rigid portion of Le therefore reads on the requirements of the claim.
Furthermore, it is noted that the “rigid portion” and length thereof of Le is interpreted in a manner which is consistent with applicant’s originally filed specification. See at least [0069] which discloses in some embodiments, waveguide 406, spacer 408, GRIN lens 410, and prism 412 (or a portion of these components) can be relatively rigid in comparison to optical fiber 302 and/or drive shaft 404, and the length of the rigid portion of these components can affect the radius of curvature through which optics 400 can be bent and the rigid length can be shorter on the order of .75 to 1.5 mm. Examiner notes that since the prism, spacer, and GRIN lens (considered a portion of the components listed by applicant) is within the recited and if optics 400 are configured to penetrate to about 360 degrees into the cochlea (i.e., 2r radians), the rigid length can be shorter (e.g., on the order of about 0.75 to 1.5 mm), where it is noted that the rigid length Le is within the range of .75 to 1.5 mm as noted in the rejection below and would therefore function in the same manner as recited/disclosed by applicant. Therefore, as noted above, the rigid portion is considered to be configured to insert into a structure with a cross-sectional area of 2 mm x 3 mm and a radius of curvature of between 2-6 mm due to its size and length, in addition to the disclosed bend radius of the probe/optical fiber of Le.
For at least the reasons listed above, applicant’s arguments against the teachings of Le are not found persuasive.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (provisional application). The disclosure of the invention in the provisional application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62538491, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. For example, the provisional application 62538491 provides support for a proof of concept of using micro-optical coherence tomography to image a cochlea, but does not provide support for the structural makeup of the optical coherence tomography tool/system of claim 1 nor the structural makeup of the device required to perform the method of imaging on the human cochlea of claim 19. For this reason, the effective filing date for claims 1-21 of the current application appears to be 07/30/2018 and has thus been examined as such.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 15, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Le et al. (US 20130331689 A1 and included in applicants IDS), hereinafter Le.
Regarding claim 1,
Le teaches an optical coherence tomography (OCT) imaging tool (at least fig. 3 (1) and corresponding disclosure in at least [0097] which discloses imaging probe 1 configured for optical coherence tomography), comprising:
An optical waveguide (at least fig. 3 (128 and 180) and corresponding disclosure in at least [0120] which discloses tube 180 and optical waveguide 128 may function as a rotating tubular shaft during use. Examiner notes that in combination the optical fiber (128) and the tube (180) surrounding the optical fiber have been interpreted as the optical waveguide in in its broadest reasonable interpretation and in light of applicant’s specification [0012] which discloses the optical waveguide comprises an optical fiber surrounded by a cladding (e.g. a tube)) having a proximal end and a distal end ([0153] which discloses the rotating shaft (i.e. 128 and 180) may have a stiffness at a distal section that is much less than the stiffness at a proximal section thus has a proximal and distal end)
A portion of the optical waveguide (128 and 180) disposed near the distal end of the optical waveguide (128 and 180) having an increased flexibility with respect to the proximal end of the optical waveguide ([0153] which discloses the rotating shaft (i.e. 128 and 180) may have a stiffness at a distal section that is much less than the stiffness at a proximal section)
a sheath (at least fig. 3 (111) and corresponding disclosure in at least [0122]) surrounding the portion of the first optical waveguide (at least fig. 3)
and an optical probe (at least fig. 3 (1) and corresponding disclosure in at least [0096]) coupled at the distal end of the optical waveguide (128 and 180) (Examiner notes the probe 1 is at least coupled to the optical waveguide 128 and 180 via the grin lens 130 as disclosed in [0131]) , the optical probe (1) comprising:
an optical element (at least fig. 3 (134) and corresponding disclosure in at least [0111]) coaxially aligned with a central axis of the distal end of the optical waveguide (128 and 180),
the optical element (134) being configured to rotate about the central axis and redirect light emitted (at least fig. 3 (28) and corresponding disclosure in at least [0098]) by the optical waveguide (128) toward a circumference of the optical probe (1) from the central axis ([0124] which discloses the optical element 134 is configured to rotate about the axis of the waveguide 128. Examiner notes the light (28) is redirected toward a circumference of the optical probe (1) in at least fig. 3),
the optical element being disposed within a housing (at least fig. 3 depicts the optical element disposed within component 110. Additionally/alternatively see at least fig. 15 (196) and corresponding disclosure in at least [0139] or fig. 16 (160) and corresponding disclosure in at least [0140])
the optical probe comprising a rigid portion comprising the optical element (Examiner notes that the optical element is a prism, GRIN lens, and spacer, or GRIN lens and spacer alone is considered to be rigid and thus the portion including the optical element, GRIN lens, and spacer constitutes the rigid portion) and
the rigid portion of the optical probe being configured to insert into a structure with a diameter of 2mmx 3 mm ([0129] which discloses In some embodiments, the working distance is within an imaging range of the minimal and maximal diameters of the lumen to be imaged. For example, in some embodiments, the lumens in a patient to be imaged may be anywhere from 100 um to 50000 um (i.e. .1mm-50 mm) in diameter. Examiner notes that such a range of lumens would include regions in which the cross-sectional area is 6 mm or 2 mm x 3 mm. In such cases, the working distance of the imaging probe 1 may be configured to provide such imaging range. Examiner thus notes that the probe and rigid portion thereof is configured to be inserted into a structure with a diameter between .1 mm and 50 mm thus regions in which the cross-sectional area is 2mm x 3 mm) and a radius of curvature of between 2-6 mm ([0174] which discloses the bend radius of the shaft 180 at the distal end may be anywhere from 1 mm to 100 mm, more preferably anywhere from 1 mm to 20 mm, and even more preferably 1 mm to 10 mm and [0181] which discloses at the distal end of the probe 1, the bend radius achievable may be anywhere from 1 mm to 100 mm).
wherein the rigid portion of the optical probe has a length of between .75 mm to 1.5 mm ([0192]-[0193] which discloses having a spacer length of 250 microns and polymer gradient index lens with a length of 600 microns and a prism with a length of 300 microns thus a rigid length of 850 microns (.85 mm) in a rigid portion interpreted to include the spacer and Grin Lens or 1150 microns (1.150 mm) in a rigid portion which includes the spacer, GRIN lens, and prism).
Regarding claim 3,
Le further discloses wherein the proximal end of the optical waveguide has a first diameter, the optical waveguide tapering to a second diameter that is smaller than the first diameter such that the portion of the optical waveguide is the second diameter (In some embodiments, the variable stiffness of the tube 180 along the length of the probe 1 may be achieved by varying the diameter of the tube 180 (see also FIG. 28). Examiner notes that the portion at which the optical element exists/rigid portion is considered the second diameter to which the optical waveguide tapers to)
Regarding claim 4,
Le further teaches wherein the portion of the first optical waveguide (128 and 180) having an increased flexibility comprises an optical fiber (at least fig. 3 (128) and corresponding disclosure in at least [0111]. [0111] which discloses optical waveguide 128 is an optical fiber) surrounded by a cladding (at least fig. 3 (180) and corresponding disclosure in at least [0120]) which is etched to remove material around the circumference of the first optical waveguide ([0155] which discloses variable stiffness along the length of tube is achieved by providing cutouts (i.e. etchings to remove material) from the wall of the tube (i.e. cladding) 180), thereby decreasing the young’s modulus elasticity of the portion of the optical waveguide ([0173] which discloses reducing stiffness of the shaft by reducing the modulus of elasticity (i.e. young’s modulus). Examiner notes that by providing cutouts to vary the stiffness, the young’s modulus (and thus the stiffness) is necessarily decreased).
Regarding claim 15,
Le further discloses wherein the optical waveguide is configured to rotate within the sheath ([0147] which discloses the optical waveguide is configured to rotate during use).
Regarding claim 17,
Le further discloses further comprising a micromotor ([0196] which discloses motor 402 may be implemented inside of the probe) coupled to the optical element, wherein the micromotor (402) is configured to rotate the optical element within the housing ([0147] which discloses a motor system for rotating an optical waveguide inside the imaging probe and [0124] which discloses the waveguide, grin lens, and optical element 134 are configured to rotate about the axis. Examiner notes rotation of the optical waveguide by the micromotor would necessarily cause the optical element to rotate within the housing).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Le in view of Sillard et al. (US 2019035841 A1 and included in applicant’s IDS), hereinafter Sillard.
Regarding claim 2,
Le, as modified, teaches the elements of claim 1 as previously stated. Le further teaches wherein the optical waveguide (128 and 140) comprises an optical fiber core (at least fig. 3 (142) and corresponding disclosure in at least [0111]) and cladding (at least fig. 3 (140) and corresponding disclosure in at least [0111]) coaxially surrounding the optical fiber core (142).
The cladding appears to be a refractive index trench in its broadest reasonable interpretation because it is hollow (i.e. trenched) to provide the core and would necessarily have a refractive index.
Nonetheless, Sillard in a similar field of endeavor involving optical fibers, teaches an optical waveguide (at least fig. 1 (10) and corresponding disclosure in at least [0061]) comprising an optical fiber core (at least fig. 1 (11) and corresponding disclosure in at least [0061]) and a refractive index trench (at least fig. 1 (13) and corresponding disclosure in at least [0061]) coaxially surrounding the optical fiber core (11) (at least fig. 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of modified Le to include a refractive index trench as taught by Sillard in order to reduce bend losses (Sillard [0018]).
Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Le in view of Tearney et al. (WO2017049085A1 and included in applicant’s IDS), hereinafter Tearney. Examiner notes that citations are with respect to the copy provided herein.
Regarding claim 5,
Le, as modified, teaches the elements of claim 5 as previously stated. Le fails to explicitly teach further comprising a second optical waveguide disposed between the distal end of the optical waveguide and the optical element, wherein the second optical waveguide is configured to act as a mirror tunnel that causes light emitted from the distal end of the optical waveguide and received at a proximal end of the second optical waveguide with a signal propagation mode to be emitted from a distal end of the second optical waveguide with multiple propagation modes towards the optical element.
Tearney, in a similar field of endeavor involving OCT imaging, teaches an optical coherence tomography (OCT) imaging tool (at least fig. 4A/4B and corresponding disclosure in at least [0097] see also at least fig. 14 and corresponding disclosure in at least [00107]) comprising:
An optical waveguide (at least fig. 4A/4B (0401) [0097] and at least fig. 14 [00107] which discloses a single mode fiber) having a proximal end and a distal end (Examiner notes that a single mode fiber would have a proximal end and see at least fig. 14 which depicts the distal end spliced to the multimode fiber see also fig. 4 depicting a proximal and distal end of the optical waveguide 0401)
A second optical waveguide (at least fig. 4A/4B (0402) [0097] and at least fig. 14 (1401) [00107]) disposed between the distal end of the optical wave guide and an optical element (See at least figs. 4 and 14)
The second optical waveguide (0402/1401) being configured to act as a mirror tunnel ([0097] which discloses mirror tunnel 0402 and [00107] which discloses multimode fiber, which is used as a mirror tunnel) that causes light that is emitted from the distal end of the first optical waveguide and received at the proximal end of the second optical waveguide with a single propagation mode to be emitted from the distal end of the second optical waveguide with multiple propagation modes ([0095] which discloses multiple propagation modes are generated by mirror tunnel, although the specific disclosure is related to the elements of fig. 3, it is noted that figs 4A/4B and 14 has the same design and appears to merely be a photograph of the design of fig. 3 and its mirror tunnel would be configured in the same manner (i.e. to generate multiple propagation modes) accordingly. Examiner notes the single mode fiber would necessarily emit a single propagation mode to be received by the proximal end of the second optical waveguide);
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Le to include a second optical waveguide as taught by Tearney in order to provide a lateral resolution better than about 5 microns and a depth of focus more than 1.5 mm (Tearney [0011]). Such a modification allows for more than a 10-fold improvement in resolution while maintaining a similar depth of focus (Tearney [0012]).
Regarding claim 6,
Le further teaches wherein the optical waveguide comprises a single mode optical fiber ([0128] which discloses the optical waveguide 128 may be an optical fiber. The Optical fiber may be a single mode fiber)
Tearny, as applied with respect to claim 5, further teaches wherein optical waveguide comprises a single mode optical fiber and the second optical waveguide comprises a multimode optical fiber ([0095] which discloses a multimode fiber is used as a mirror tunnel)
Regarding claim 7,
Le, as modified, teaches the elements of claim 5 as previously stated. Le further teaches wherein the optical element (134) is a prism ([0104] which discloses beam director (134) is a prism) and the optical probe (1) further comprises spacer (at least fig. 18 (310) and corresponding disclosure in at least [0144]) disposed at the distal end of the optical waveguide (see at least fig. 18 and [0144] which discloses in one or more embodiments (e.g. in any of the embodiments of figs. 3-16), the imagine probe may include a fiber spacer 310 disposed between the optical fiber core 142 and the grin lens 130), and a gradient index (GRIN) lens (at least fig. 3 (130) and corresponding disclosure in at least [0111]) is disposed between the spacer and the optical element (see at least fig. 18).
Le, as currently modified, fails to explicitly teach the spacer disposed at the distal end of the second optical waveguide.
Nonetheless, Tearney further teaches wherein the optical element is a prism (0405/1404), and the optical probe further comprise
a spacer (at least fig. 4A/4B (0403) [0097] and at least fig. 14 (1402) [00107]) disposed at the distal end of the second optical waveguide (1401) (see at least fig. 4A/4B and fig. 14), and
a gradient index (GRIN) lens (at least 4A/4B (0404)[0097] and at least fig. 14 (1403)[00107]) disposed between the spacer (0403/1402) and the prism (0405/1404)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Le, as currently modified, to include the spacer disposed at the distal end of the second optical waveguide as taught by Tearney in order to allow the beam transmitted from the second optical waveguide to diverge (increase in diameter) before optical transmission into the grin lens 130 to thereby achieve a longer or shorter working distance, larger or smaller focus spot size, and/or longer or shorter depth of focus depending on the length of the fiber spacer (Le [0144]).
Regarding claim 8,
Le teaches the elements of claim 1 as previously stated. Le further teaches wherein the optical element is a mirror or prism ([0104]) and the optical probe further comprises a spacer (at least fig. 18 (310) and corresponding disclosure in at least [0144]) disposed between the optical wave guide and the optical element (see at least fig. 18)
Le, as currently modified, fails to explicitly teach wherein the optical element is a polished ball lens and the spacer is disposed between the second optical waveguide and the polished ball lens.
Tearney further teaches wherein the optical element (at least fig. 4B (0406) [0097]) is a polished ball lens ([0097]) and the optical probe further comprises a spacer (at least fig. 4B (0403) and corresponding disclosure in at least [0097]) is disposed between the second optical waveguide and the polished ball lens (see at least fig. 4B)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of have modified the system of Le, as currently modified, to include a polished ball lens as taught by Tearney in order to provide appropriate focusing for the side-view imaging (Tearney [0097]). Furthermore, such a modification amounts to merely a simple substitution of one known optical element for another yielding predictable results with respect to OCT imaging thereby rendering the claim obvious (MPEP 2143).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Le, as currently modified, to include the spacer disposed between the second optical waveguide and the polished ball lens as taught by Tearney in order to allow the beam transmitted from the second optical waveguide to diverge (increase in diameter) before optical transmission into the polished ball lens of Tearney to thereby achieve a longer or shorter working distance, larger or smaller focus spot size, and/or longer or shorter depth of focus depending on the length of the fiber spacer (Le [0144]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Le in view of Foreign Kazuhiro (JP 2015198723 A and included in applicant’s IDS), hereinafter Kazuhiro. Examiner notes that citations are with respect to the translated copy provided herein.
Regarding claim 9,
Le teaches the elements of claim 1 as previously stated. Le further teaches wherein the optical element has an angled reflective surface that redirects the light emitted by the optical waveguide (128) toward the circumference of the optical probe from the central axis as a beam have a spot profile (at least fig. 4).
While Le teaches an axicon may be present in the imaging probe 1 ([0195]), Le fails to explicitly teach wherein the optical element has a cylindrical bore coaxially aligned with the first optical waveguide, and an angled reflective surface that redirects the light emitted by the first optical waveguide toward the circumference of the optical probe from the central axis as a beam with an annular-shaped profile.
Kazuhiro, in a similar field of endeavor involving OCT imaging, teaches an optical element (at least fig. 3 (4) and corresponding disclosure in at least [0014]), wherein the optical element (4) has a cylindrical bore (at least fig. 3 and [0027] which discloses the mirror is perforated having a through hole formed within), and an angled reflective surface (at least fig. 3) that redirects the light emitted as a beam with a generally annular shaped profile (at least fig. 3. Examiner notes the beam reflected from the angled reflective surface appears to have a generally annular shaped profile), wherein the cylindrical bore passes through the reflective surface (at least fig. 3).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of modified Le to include an optical element as taught by Kazuhiro in order to redirect the light accordingly. Such a modification amounts to merely one known optical element for another yielding predictable results with respect to OCT imaging thereby rendering the claim obvious (MPEP 2143).
Examiner notes in the modified system, the bore as depicted in fig. 3 would necessarily be coaxially aligned with the optical waveguide of Le.
Claims 10-11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Le in view of Taylor et al. (US 20120172893 A1 and included in applicant’s IDS), hereinafter Taylor.
Regarding claim 10,
Le teaches the elements of claim 1 as previously stated. Le fails to explicitly teach a stimulator configured to provide stimulation to a portion of an auditory nerve of a subject; and a conductor coupled to the stimulator, wherein the conductor is configured to transmit a signal from a controller to the stimulator.
Taylor, in a similar field of endeavor involving optical coherence imaging, teaches an optical coherence tomography (OCT) imaging tool (See at least fig. 2 and abstract which discloses an OCT system), comprising:
An optical probe (at least fig. 2 (18) and corresponding disclosure in at least [0026]) comprising an optical waveguide ([0027] which discloses the sensor may comprise an optical waveguide) disposed within a sheath (at least fig. 2 (14) and corresponding disclosure in at least [0024]).
A stimulator (at least fig. 1 (20) and corresponding disclosure in at least [0024]) configured to provide stimulation to a portion of an auditory nerve of a subject ([0024] which discloses the electrode array receives signals which cause the auditory nerve to be stimulated); and
A conductor (at least fig. 1 (22) and corresponding disclosure in at least [0024]) coupled to the stimulator wherein the conductor (22) is configured to transmit a signal ([0024] which discloses the electrode and electrode cable (i.e. conductor) are connected to a stimulator unit. Examiner notes the stimulator unit would transmit the signals to the electrode array via the cable) to the stimulator (20)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of modified Le to include a stimulator and conductor as taught by Taylor in order to provide stimulation to the ear (specifically the cochlea) accordingly. Such a modification amounts to merely a combination of prior art elements according to known techniques to yield predictable results with respect to medical procedures performed in the ear rendering the claim obvious (MPEP 2143).
Regarding claim 11,
Le as modified, teaches the elements of claim 10 as previously stated. Taylor, as applied to claim 10 above, further teaches wherein the stimulator (20) comprises an electrode ([0024] which discloses stimulator (20) is an electrode array) disposed at an exterior surface of the sheath (14).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Le to include electrodes disposed at an exterior surface of the sheath as taught by Taylor in order to provide stimulation to the cochlea accordingly.
Regarding claim 13,
Le, as modified, teaches the element of claim 10 as previously stated. Taylor, as applied to claim 10 above appears to teach the conductor integrated into the sheath (14).
Nonetheless, It would have been obvious to a person having ordinary skill in the art before the effective filing date to have integrated the conductor of Taylor into the Sheath of Le in order to secure the conductor to the imaging probe when guiding the stimulator to the auditory nerve.
Regarding claim 14,
Le, as modified, teaches the elements of claim 10 as previously stated. Le further teaches wherein the first optical waveguide (128 and 180) is disposed within a first lumen of the sheath (111) (examiner notes the optical waveguide would be disposed within a lumen in order to be included within the sheath which is a separate component).
Le, as modified, fails to explicitly teach a second lumen in the sheath (111) and wherein the conductor of Taylor is disposed within the second lumen.
It appears the conductor of Taylor would require a lumen in order to be placed within the sheath (14).
Nonetheless, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Le to include a second lumen in the sheath and disposing the conductor within a second lumen of the sheath in order to hold the conductor in place accordingly. Such a modification amounts to merely a duplication of parts (e.g. lumens) rendering the claim obvious (MPEP 2144.04).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Le and Taylor as applied to claim 10 above and further in view of Mclaughlin et al. (US 20120287420 A1 and included in applicant’s IDS), hereinafter Mclaughlin.
Regarding claim 12,
Le, as modified, teaches the elements of claim 10 as previously stated. Taylor further teaches wherein the stimulator (20) comprises an electrode ([0024] which discloses stimulator (20) is an electrode array) disposed at an exterior surface of the sheath (14).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Le to include electrodes disposed at an exterior surface of the sheath as taught by Taylor in order to provide stimulation to the cochlea accordingly.
Le, as modified, fails to explicitly teach wherein the stimulator (20) comprises an optrode.
McLaughlin, in a similar field of endeavor involving neural stimulation, teaches an optrode for stimulating neural activity ([0007] which discloses an optrode for optically and electrically stimulating neural activity).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified the system of Le to include an optrode as taught by Mclaughlin in order to optically and electrically stimulate and record neural activity accordingly ([0007]). Such a modification amounts to merely a simple substitution of one known stimulation means for another rendering the claim obvious (MPEP 2143).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Le in view of Kuroiwa (US 20080260342 A1 and included in applicant’s IDS), hereinafter Kuroiwa.
Regarding claim 16,
Le teaches the elements of claim 1 as previously stated. Le further teaches further comprising a driveshaft (at least fig. 20 (412) and corresponding disclosure in at least [0147]) coupled to the optical element (Examiner notes element 426 of fig. 20 is coupled to the optical element via optical waveguide (128)) and wherein rotation of the driveshaft (412) causes the optical waveguide (128) to rotate within the sheath (20) ([0147] which discloses the motor is a technique employed to rotate the optical waveguide (128) inside the imaging probe 1).
Le fails to explicitly teach wherein the drive shaft surrounds the optical waveguide.
Kuroiwa, in a similar field of endeavor involving optical probes, teaches a driveshaft (at least fig. 10B (17) and corresponding disclosure in at least [0079]) coupled to the optical element (15) and surrounding an optical waveguide (12) (at least fig. 10B) such that rotation of the driveshaft causes the optical waveguide (12) and the optical element (15) to rotate ([0082] which discloses as the flexible shaft is rotated, the optical fiber (12) and prism (15) are also rotated).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified they system of Le as currently modified to include a driveshaft as taught by Kuroiwa in order to control rotation and ensure uniform rotation of the optical waveguide along its entire length.
Examiner notes in the modified system the first optical waveguide would thus rotate within the sheath of Le
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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