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 .
Response to Amendment
The amendment filed on 11/14/2025 has been entered. Claims 1, 11, 17 and 19 have been amended. Claims 7-8, 12, 15, 18 and 20 have been cancelled. Claims 1-6, 9-11, 13-14, 16-17 and 19 remain pending.
The previously raised objection for Claim 17 is withdrawn because the issue has been properly corrected.
The previous rejections for Claims 1-6 and 9-10 under 35 U.S.C. 112(b) remain because the previously raised issues have not been corrected.
The previous rejections for Claims 11, 13-14, 16-17 and 19 under 35 U.S.C. 101 are withdrawn.
Response to Arguments
On Page 10-11 of Remarks, the Applicant argues that, with respect to the amended Claim 1, the reference Wang fails to teach “compute a ratio of the first intensity value and the second intensity value”, “determine a distance between the distal end of the optical fiber and the target based on the ratio” and “determine the reflectivity of the target based in part of the distance”, and that the rejection of the amended Claim 11 and Claim 17 using the reference Wang has the same issue.
The Examiner respectfully disagrees. In Equations 25-27, Wang computes a “ratio” (see details in section of U.S.C. 103 rejection), computes reflectivity according to longitudinal distance (Wang, Column 20 Line 65 to Column 21 Line 1, “By varying the path length difference in the system and record the oscillation waveforms we can therefore acquire the reflection coefficient r as a function of the longitudinal distance z, or depth”), and discloses a relationship between signal intensity, distance and/or reflectivity, which is also disclosed in Equation 15. In current office action, for a rejection with reference of more explicit and clear disclosure, Ono et al (US 20010021011 A1) is introduced to teach Wang in rejecting the amended Claims 1, 11 and 17.
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.
Claims 1-6 and 9-10 are 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.
With regard to Claim 1, on line 8 it recites “the reflected light”. On lines 6-7, two types of reflected light are recited, including “to reflect a portion of the laser light from the proximal end” on line 6 and “to receive reflected laser light into the distal end”. It is unclear which of these two types is referred to by the term “the reflected light” on line 8. For present purposes of examination, the term “the reflected light” is interpreted as the portion of light that emit the distal end and then after reflection is received into the distal end. Clarification is required.
With regard to Claims 4 and 6, relative term “approximately” is a relative term that is used for all the values of wavelength, which renders the claims indefinite. The term “approximately” is not defined by the claims or the specification. Clarification is required.
Claims 2-3, 5, 9-10 are also rejected under 35 U.S.C. 12(b) because they inherit the indefiniteness of the claim(s) they respectively depend upon.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 9-11, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (US 7831298 B1; hereafter Wang), in view of Ono et al (US 20010021011 A1; hereafter Ono).
With regard to Claim 1, Wang discloses a system, comprising:
a first laser source to generate laser light of a first wavelength (λ1 in Fig. 25);
a second laser source to generate laser light of a second wavelength (λ2 in Fig. 25) (Wang, Column 32, Lines 5-6; “FIG. 25 shows an optical device 2500 that uses two or more different light sources 2510 at different optical wavelengths … ”);
an optical fiber (Wang, Column 32, Lines 20-24; “… to combine these optical waves into a common optical path, i.e., the common optical waveguide 271. The light director 210 directs the combined optical radiation to the probe head 220 via a common waveguide 272.”) having a distal end (the lower end of “Dual-Mode Waveguide 272” in Fig. 25) and a proximal end (the left end of 271 in Fig. 25), the optical fiber configured to receive laser light from the first and second laser sources at the proximal end (Wang, Column 32, Lines 20-22; “… to combine these optical waves into a common optical path, i.e., the common optical waveguide 271.”), to reflect a portion of the laser light from the proximal end (Wang, Column 33, Lines 52-54; “With this arrangement not all the light power will be multiplexed into the optical fiber, as loss of optical power occurs at each reflector.”), to emit a portion of the laser light out of the distal end (Wang, Column 32, Lines 24-27; “The probe head 220 … split a portion of light from the multiplexed or combined optical radiation as the probe light and direct this probe light to the sample 205.”), and to receive reflected laser light into the distal end (Wang, Column 32, Lines 27-29; “The reflected light from the sample 205 is collected by the probe head 220 …”);
a light detector to measure intensity of the reflected light (Wang, Column 32, Lines 36-39; “Accordingly, an array of different optical detector modules 2540 are used to respectively receive and detect the separated beams of different wavelength bands.”); and
a processor and memory comprising instructions (Wang, Column 33, Lines 3-6; “FIG. 26 shows one implementation 2600 of the device 2500 in FIG. 25 where a digital signal processor (DSP) 2610 is used to process the detector outputs from the detector module 2540 … ”) that when executed by the processor cause the processor to determine whether a reflectivity (SAM (spectral absorbance mapping)) of a target is greater than or equal to a threshold reflectivity (Wang, Column 36, Lines 29-33; “… the optical probing module 3320 is used to measure each SPN identified by the CT scan. This is a differential diagnosis and the optical measurement is analyzed to determine whether each SPN is benign or malignant.”) based on the measured intensity of the reflected light (Wang, Column 32, Lines 66-67; “Each reflectance map is formed by radiation within the band of one light source. These reflectance maps can then be used to derive SAM using an algorithm based on the principles outlined by Equations (15) through (17).”),
wherein the light detector measures a first intensity value of the reflected light corresponding to the laser light of the first wavelength and a second intensity value of the reflected light corresponding to the laser light of the second wavelength (Wang, Column 32, Lines 39-42; “The light at the two different selected optical wavelengths λ1 and λ2 from the optical head is directed to a wavelength demultiplexer which separates the received light into two different optical paths that lead to two different optical detector modules D1 and D2, respectively. The detector signals from the detector modules D1 and D2 are then processed by a DSP module to obtain two cross-sectional reflectance images of the tissue at the two chosen wavelengths: A(λ1, x, z) and A(λ2, x, z).” Figs. 25 and 37 demonstrate the separation of the signals using a demultiplexer), and
wherein the instructions, when executed by the processor, further cause the processor to:
compute a ratio of the first intensity value and the second intensity value (Wang, Column 41, Eq (27) computes a ratio of Eq (26) over Eq (25), where Eq (25) corresponds to an intensity value of wavelength λ1 and Eq (26) an intensity value of λ2. Note that, disclosed as a method of voxel-wise mapping, each of Eq (25) and Eq (26) is expressed as a ratio of intensities of reflected light at two different z locations (z0-Δz/2 and z0+Δz/2), which can be interpreted as an intensity value corresponding to a wavelength value); and
determine the reflectivity of the target based in part of the distance (Wang, Column 20 Line 65 to Column 21 Line 1, “By varying the path length difference in the system and record the oscillation waveforms we can therefore acquire the reflection coefficient r as a function of the longitudinal distance z, or depth.”. In the Application, the term “reflection coefficient” (in Equation 1) and “reflectivity” (in Equation 6) are treated equally, both denoted as R).
Wang does not clearly and explicitly disclose determining a distance between the distal end of the optical fiber and the target based on the ratio.
Ono in the same field of endeavor discloses determining a distance between the distal end of the optical fiber and the target based on the ratio (Ono, Para 0118;“Based on the ratio of the intensity of the first reflected light and a half of the intensity of the second reflected light, the depth-direction distance to the subject can be calculated”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang, as suggested by Ono, in order to calculate a distance to a target or subject. One of ordinary skill in the art would have been motivated to make the modification for the benefit of providing the position information of a target relative to the probe head, which could guide and therefore improve precision of the following treatment.
With regard to Claim 9, Wang and Ono disclose the system of Claim 1. Wang further discloses wherein one or more of the first and second laser sources comprise a polarization maintaining pigtailed fiber laser (Wang, Column 29, Lines 31-33; “A broadband or low-coherence light from Broadband Light Source 201 is directed to a probe head 2110 by means of polarization-maintaining waveguides 271 and 272”), a single mode pigtailed fiber laser (Wang, Column 11, Lines 9-10; “… where light in a single mode is used as the input light.”), or a free space laser.
With regard to Claim 10, Wang and Ono disclose the system of Claim 1. Wang further discloses comprising a wave division multiplexer (WDM) coupled to a proximal end of the optical fiber, the WDM to arrange the laser light of the first wavelength and the laser light of the second wavelength to enter a proximal end of the optical fiber at one or more of a same point and a same angle (Wang, Column 32, Lines 19-21; “An optical multiplexer 2520 is used to receive the optical radiations from different light sources 2510, to combine these optical waves into a common optical path …”).
With regard to Claim 11, Wang discloses at least one non-transitory computer-readable medium comprising a set of instructions that, in response to being executed by a processor circuit, cause the processor circuit (Computing and control module 3350 in Fig. 33) to:
generate, during a surgical laser procedure (Wang, Column 2, Lines 50-64; “… a medical device includes a bronchoscope … and a laser therapy module comprising a power delivery optic fiber having a portion inserted into the working channel of the bronchoscope to deliver a treatment laser beam to the target area.”), a control signal to cause a first laser source to generate laser light of a first wavelength (λ1 in Fig. 25) and to cause a second laser source to generate laser light of a second wavelength (λ2 in Fig. 25) different than the first wavelength (Wang, Column 32, Lines 5-6; “FIG. 25 shows an optical device 2500 that uses two or more different light sources 2510 at different optical wavelengths …”), wherein the laser light of the first wavelength and the laser light of the second wavelength are combined into a composite laser beam in a surgical laser system (Wang, Column 32, Lines 19-21; “An optical multiplexer 2520 is used to receive the optical radiations from different light sources 2510, to combine these optical waves into a common optical path …”), wherein the surgical laser system is coupled to an optical fiber (Wang, Column 32, Lines 46-48; “The multiplexed light radiations are delivered to the tissue through the optical waveguide 272 or fiber and the probe head 220.”) and the optical fiber emits, during the surgical laser procedure, the composite laser beam from a distal end of the optical fiber (Wang, Column 32, Lines 24-27; “The probe head 220 … split a portion of light from the multiplexed or combined optical radiation as the probe light and direct this probe light to the sample 205.”) and receives, during the surgical laser procedure, reflected light, wherein the reflected light is a reflection of the composite laser beam off a target (Wang, Column 32, Lines 27-29; “The reflected light from the sample 205 is collected by the probe head 220 …”);
receive, from a light detector (Wang, Column 32, Lines 36-39; “Accordingly, an array of different optical detector modules 2540 are used to respectively receive and detect the separated beams of different wavelength bands.”) during the surgical laser procedure, a first intensity value of a first portion of the reflected light and a second intensity value of a second portion of the reflected light, wherein the first portion has the first wavelength and the second portion has the second wavelength (Wang, Column 32, Lines 39-42; “The light at the two different selected optical wavelengths λ1 and λ2 from the optical head is directed to a wavelength demultiplexer which separates the received light into two different optical paths that lead to two different optical detector modules D1 and D2, respectively.”);
compute, during the surgical laser procedure, a ratio of the first intensity value and the second intensity value (Wang, Column 41, Eq (27) computes a ratio of Eq (26) over Eq (25), where Eq (25) corresponds to an intensity value of wavelength λ1 and Eq (26) an intensity value of λ2. Note that, disclosed as a method of voxel-wise mapping, each of Eq (25) and Eq (26) is expressed as a ratio of intensities of reflected light at two different z locations (z0-Δz/2 and z0+Δz/2), which can be interpreted as an intensity value corresponding to a wavelength value);
determine, during the surgical laser procedure, the reflectivity of the target based on the distance (Wang, Column 20 Line 65 to Column 21 Line 1, “By varying the path length difference in the system and record the oscillation waveforms we can therefore acquire the reflection coefficient r as a function of the longitudinal distance z, or depth.”. In the Application, the term “reflection coefficient” (in Equation 1) and “reflectivity” (in Equation 6) are treated equally, both denoted as R); and
determine, during the surgical laser procedure, whether a reflectivity (SAM (spectral absorbance mapping)) of a target is greater than or equal to a threshold reflectivity (Wang, Column 36, Lines 29-33; “… the optical probing module 3320 is used to measure each SPN identified by the CT scan. This is a differential diagnosis and the optical measurement is analyzed to determine whether each SPN is benign or malignant.”).
Wang does not clearly and explicitly disclose determining a distance between the distal end of the optical fiber and the target based on the ratio of the first intensity value and the second intensity value.
Ono in the same field of endeavor discloses determining a distance between the distal end of the optical fiber and the target based on the ratio of the first intensity value and the second intensity value (Ono, Para 0118;“Based on the ratio of the intensity of the first reflected light and a half of the intensity of the second reflected light, the depth-direction distance to the subject can be calculated”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang, as suggested by Ono, in order to calculate a distance to a target or subject. One of ordinary skill in the art would have been motivated to make the modification for the benefit of providing the position information of a target relative to the probe head, which could guide and therefore improve precision of the following treatment.
With regard to Claim 17, Wang discloses a method for a controller of a surgical laser system (Wang, Fig. 25 shows an optical device that inherently contains a method that controls light emitting and receiving; Wang, Fig. 34 shows the entire surgical laser system), comprising:
sending, during a surgical laser procedure, a control signal to cause a first laser source of the surgical laser system to generate laser light of a first wavelength (Wang, Column 32, Line 5-6; “FIG. 25 shows an optical device 2500 that uses two or more different light sources 2510 at different optical wavelengths…”. The first wavelength corresponds to λ1 in Fig. 25);
sending, during the surgical laser procedure, a control signal to cause a second laser source of the surgical laser system to generate laser light of a second wavelength different than the first wavelength (Wang, Column 32, Line 5-6; “FIG. 25 shows an optical device 2500 that uses two or more different light sources 2510 at different optical wavelengths …”. The second wavelength corresponds to λ2 in Fig. 25), wherein the laser light of the first wavelength and the laser light of the second wavelength are combined into a composite laser beam in the surgical laser system (Wang, Column 32, Lines 19-21; “An optical multiplexer 2520 is used to receive the optical radiations from different light sources 2510, to combine these optical waves into a common optical path …”), wherein the surgical laser system is coupled to an optical fiber (Wang, Column 32, Lines 46-48; “The multiplexed light radiations are delivered to the tissue through the optical waveguide 272 or fiber and the probe head 220.”) and the optical fiber emits, during the surgical laser procedure, the composite laser beam from a distal end of the optical fiber (Wang, Column 32, Lines 24-27; “The probe head 220 … split a portion of light from the multiplexed or combined optical radiation as the probe light and direct this probe light to the sample 205.”) and receives, during the surgical laser procedure, reflected laser light, wherein the reflected laser light is a reflection of the composite laser beam off a target (Wang, Column 32, Lines 27-29; “The reflected light from the sample 205 is collected by the probe head 220 …”);
determining, by at least one of one or more light detectors, a first intensity value based on first reflected laser light corresponding to laser light of a first wavelength (Wang, Column 32, Lines 39-42; “… light radiation centered at the wavelength λ1 … is separated from the rest and sent to the detector module 1 (D1).”);
determining, by at least one of one or more light detectors, a second intensity value based on second reflected laser light corresponding to laser light of a second wavelength (Wang, Fig. 25 shows D2, the intensity of the reflected light corresponding to the laser light of the second wavelength.);
computing, during the surgical laser procedure, a ratio of the first intensity value and the second intensity value (Wang, Column 41, Eq (27) computes a ratio of Eq (26) over Eq (25), where Eq (25) corresponds to an intensity value of wavelength λ1 and Eq (26) an intensity value of λ2. Note that, disclosed as a method of voxel-wise mapping, each of Eq (25) and Eq (26) is expressed as a ratio of intensities of reflected light at two different z locations (z0-Δz/2 and z0+Δz/2), which can be interpreted as an intensity value corresponding to a wavelength value);
determining, during the surgical laser procedure, the reflectivity of the target based on the distance (Wang, Column 20 Line 65 to Column 21 Line 1, “By varying the path length difference in the system and record the oscillation waveforms we can therefore acquire the reflection coefficient r as a function of the longitudinal distance z, or depth.”. In the Application, the term “reflection coefficient” (in Equation 1) and “reflectivity” (in Equation 6) are treated equally, both denoted as R); and
determining, during the surgical laser procedure, whether the reflectivity of the target (SAM (spectral absorbance mapping)) is greater than a threshold reflectivity (Wang, Column 36, Lines 29-33; “… the optical probing module 3320 is used to measure each SPN identified by the CT scan. This is a differential diagnosis and the optical measurement is analyzed to determine whether each SPN is benign or malignant.”).
Wang does not clearly and explicitly disclose determining a distance between the distal end of the optical fiber and the target based on the ratio of the first intensity value and the second intensity value.
Ono in the same field of endeavor discloses determining a distance between the distal end of the optical fiber and the target based on the ratio of the first intensity value and the second intensity value (Ono, Para 0118;“Based on the ratio of the intensity of the first reflected light and a half of the intensity of the second reflected light, the depth-direction distance to the subject can be calculated”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang, as suggested by Ono, in order to calculate a distance to a target or subject. One of ordinary skill in the art would have been motivated to make the modification for the benefit of providing the position information of a target relative to the probe head, which could guide and therefore improve precision of the following treatment.
With regard to Claim 19, Wang and Ono disclose the method of Claim 17. Wang further discloses comprising measuring the first intensity value of the reflected laser light corresponding to laser light of the first wavelength (Wang, Column 32, Lines 39-42; “… light radiation centered at the wavelength λ1 … is separated from the rest and sent to the detector module 1 (D1).”) and measuring the second intensity value of the reflected laser light corresponding to laser light of the second wavelength (Wang, Fig. 25 shows D2, the intensity of the reflected light corresponding to the laser light of the second wavelength.).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Ono, as evidenced by Kou et al (Applied Optics, 32(19): 3531-3540; hereafter Kou).
With regard to Claim 2, Wang and Ono disclose the system of Claim 1. Wang further discloses wherein the first wavelength (λ2 at 910 nm) has a first water absorption coefficient higher than a second water absorption coefficient of the second wavelength (λ1 at 750 nm) (Wang, Column 39, Lines 55-57; “the light source at λ1 may be at 750 nm with a FWHM of about 25 nm and the light source at λ2 may be at 910 nm with a FWHM of about 50 nm.”) (The citation of Wang does not explicitly show the relationship between water absorption coefficient of the two wavelength values, but Kou, Table 2 shows that for light at wavelength of 0.9107 μm (910.7 nm), imaginary part of the refractive index of water (parameter k, proportional to water absorption coefficient) is 5.21x10-7, higher than 1.70x10-7 for light at 0.7496 μm (749.6 nm).).
With regard to Claim 3, Wang and Ono disclose the system of Claim 2, and as evidenced by Kou, the ratio of the first water absorption coefficient (5.21x10-7) to the second water absorption coefficient (1.70x10-7) is at least 2 to 1 (Kou, Table 2 shows that for light at wavelength of 0.9107 μm (910.7 nm), imaginary part of the refractive index of water (parameter k, proportional to water absorption coefficient) is 5.21x10-7, higher than 1.70x10-7 for light at 0.7496 μm (749.6 nm).).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Wang and Ono, in view of Na et al (US 20210381960 A1; hereafter Na).
With regard to Claim 4, Wang and Ono disclose the system of Claim 3, but do not clearly and explicitly disclose wherein the first wavelength is approximately 1330nm to approximately 1380nm and the second wavelength is approximately 1260nm to approximately 1320nm.
Na in an analogous field of endeavor discloses wherein the first wavelength is approximately 1330nm to approximately 1380nm and the second wavelength is approximately 1260nm to approximately 1320nm (Na, Para 0109; “the first wavelength and the second wavelength can be different, which could be … 1310 nm /1350 nm … and/or any other suitable wavelength to perform the sensing.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang and Ono, as suggested by Na, in order to use laser light of the abovementioned wavelength values. One of ordinary skill in the art would have been motivated to make the modification for the benefit of the safety for the user’s vision and at the same time allow the usage of high power light device (Na, Para 0105; “light wavelengths in the near-infrared (NIR, e.g., wavelength range from 780 nm to 1400 nm …) spectrum can be detected. This can more readily allow for Maximum Permissible Exposure (MPE) constraints used to protect bystanders' eyes in the visible spectrum to be satisfied while allowing for higher power light devices (e.g., lasers) to be used.”).
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wang, Ono and Na, further in view of Koifman et al (US 20130235369 A1; hereafter Koifman) and as evidenced by Kou.
With regard to Claim 5, Wang, Ono and Na disclose the system of Claim 4, but do not clearly and explicitly disclose comprising a third laser source to generate laser light of a third wavelength utilized to characterize a condition of the optical fiber, wherein the third wavelength has a third water absorption coefficient higher than the first and the second water absorption coefficients.
Koifman in the same field of endeavor discloses comprising a third laser source to generate laser light of a third wavelength utilized to characterize a condition of the optical fiber (Koifman, Abstract; “A method of evaluating integrity of a fiber comprises transmitting a measurement light beam through the optical fiber and measuring an intensity of a combined reflection of the measurement light beam.”), wherein the third wavelength has a third water absorption coefficient higher than the first and the second water absorption coefficients (Koifman, Para 0012; “The term "laser" as used herein in this application refers to any type of laser … diode (e.g. in various wavelengths, such as in the range 532-1600 nm)”. As evidenced by Kou in Table 2, light of wavelength 1400-1600 nm has parameter k in range of 1x10-4 ~ 3.39x10-4, much higher than that of the first and the second wavelengths). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang, Ono and Na, as suggested by Koifman, in order to use light with high water absorption coefficient for characterizing a condition of the optical fiber. One of ordinary skill in the art would have been motivated to make the modification for the benefit of minimizing reflection from the tissue or environment so as to directly use the intensity of the reflected signal to assess the distal end of the fiber (Koifman, Para 0031; “When the environment reflection is neglected, the distal end component, P2, is then calculated by summing up P2s and Pr.”).
With regard to Claim 6, Wang, Ono, Na and Koifman disclose the system of Claim 5, but do not clearly and explicitly disclose wherein the third wavelength comprises approximately 1435 nm, approximately 2100nm, or a wavelength between approximately 1870 nm and approximately 2050nm.
Koifman further discloses wherein the third wavelength comprises approximately 1435 nm, approximately 2100nm, or a wavelength between approximately 1870 nm and approximately 2050nm (Koifman, Para 0012; “The term "laser" as used herein in this application refers to any type of laser … diode (e.g. in various wavelengths, such as in the range 532-1600 nm)”) (Koifman further discloses that in absence of environment (including tissue or target) reflection, the calculation of the reflection by the distal end of the fiber would become simpler; Para 0031; “When the environment reflection is neglected, the distal end component, P2, is then calculated by summing up P2s and Pr.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang, Ono, Na and Koifman, as further suggested by Koifman, in order to use one of the abovementioned wavelength values for characterizing the condition of a laser fiber. One of ordinary skill in the art would have been motivated to make the modification for the benefit of simplifying the procedure of the characterization of optical fiber (Koifman, Para 0031; “When the environment reflection is neglected, the distal end component, P2, is then calculated by summing up P2s and Pr.”).
Claims 13-14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Ono, in view of Kowalewski et al (US 10646275 B2; hereafter Kowalewski).
With regard to Claim 13, Wang and Ono disclose the at least one non-transitory computer-readable medium of Claim 11, but do not clearly and explicitly disclose wherein the set of instructions, in response to execution by the processor circuit, further cause the processor circuit to determine that the target is stone based on a determination that the reflectivity is greater than or equal to the threshold reflectivity.
Kowalewski in the same field of endeavor discloses wherein the set of instructions, in response to execution by the processor circuit, further cause the processor circuit to determine that the target is stone (Kowalewski, Column 14, Lines 13-20; “the material type determining logic 518 may determine that the type of the material in the region 506 comprises non-biological material, such as … calcium deposits (e.g., calcium oxide, calcium carbonate, calcium phosphates) …”) based on a determination that the reflectivity is greater than or equal to the threshold reflectivity (Kowalewski, Column 15, Lines 10-15; “The information from the optical property determining logic 516 regarding the determined at least one property of the region 506 may, for example, be compared against information in the library to determine the type of the material in the region 506 ...”. To one skilled in the art, the reflectivity of stone or calcified substances is inherently higher than that of most soft tissue). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang and Ono, as suggested by Kowalewski, in order to determine a target to be stone based on the target’s reflectivity. One of ordinary skill in the art would have been motivated to make the modification for the benefit of detecting stone or calcified substances to prepare for possible ablation treatment (Kowalewski, Column 14, Lines 38-43; “The material distance determining logic 520, and/or the material type determining logic 518, may also determine whether the material in the region 506 is a proper target for laser ablation (e.g., based on the type of the material in the region 506 and/or the distance to the material in the region 506).”).
With regard to Claim 14, Wang, Ono and Kowalewski disclose all the limitations of Claim 13 as discussed above, but do not clearly and explicitly disclose wherein the set of instructions, in response to execution by the processor circuit, further cause the processor circuit to generate subsequent control signal to cause the first laser source to stop generating laser light of the first wavelength and to cause the second laser source to stop generating laser light of the second wavelength based on a determination that the reflectivity is not greater than or equal to the threshold reflectivity.
Kowalewski further discloses wherein the set of instructions, in response to execution by the processor circuit, further cause the processor circuit to generate subsequent control signal to cause the first laser source to stop generating laser light of the first wavelength and to cause the second laser source to stop generating laser light of the second wavelength (Kowalewski, Column 14, Lines 49-57; “The material type determining logic 518 and the material distance determining logic 520 may also or alternatively be configured to cause the at least one controller 180 to generate, such as via the I/O device(s) 512, an alert based on the determined type of the material in the region 506 and/or the determined distance to the material. The alert may, for example, prompt a clinician to adjust an intensity of the light source (e.g., laser source 500 or diagnostic light source 502), power off the light source …”) based on a determination that the reflectivity is not greater than or equal to the threshold reflectivity (Kowalewski, Column 15, Lines 10-15; “The information from the optical property determining logic 516 regarding the determined at least one property of the region 506 may, for example, be compared against information in the library to determine the type of the material in the region 506 ...”. To one skilled in the art, the reflectivity of tissue is lower than that of stone or calcified substances.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang, Ono and Kowalewski, as further suggested by Kowalewski, in order to stop generating laser light when the target’s reflectivity is lower than some threshold. One of ordinary skill in the art would have been motivated to make the modification for the benefit of protecting some tissue such as the superior vena cava from being injured by the laser light (Kowalewski, Column 14, Lines 6-13; “the analysis by the material type determining logic 518 may …, which may be particularly useful in assisting a clinician in avoiding dangerous SVC tears when performing ablation using the laser catheter 170.”).
With regard to Claim 16, Wang and Ono disclose all the limitations in Claim 11 as discussed above, but do not clearly and explicitly disclose wherein the set of instructions, in response to execution by the processor circuit, further cause the processor circuit to communicate an indication of the type of the target based on the reflectivity.
Kowalewski in the same field of endeavor discloses wherein the set of instructions, in response to execution by the processor circuit, further cause the processor circuit to communicate an indication (Kowalewski, Column 14, Lines 49-57; “The material type determining logic 518 and the material distance determining logic 520 may also or alternatively be configured to cause the at least one controller 180 to generate, such as via the I/O device(s) 512, an alert based on the determined type of the material in the region 506 …”) of the type of the target based on the reflectivity (Kowalewski, Column 15, Lines 10-14; “The information from the optical property determining logic 516 regarding the determined at least one property of the region 506 may, for example, be compared against information in the library to determine the type of the material in the region 506 ...”.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang and Ono, as suggested by Kowalewski, in order to communicate an indication of the type of the target based on the reflectivity. One of ordinary skill in the art would have been motivated to make the modification for the benefit of planning for the following treatment steps based on the type of target (Kowalewski, Column 14, Lines 38-43; “The material distance determining logic 520, and/or the material type determining logic 518, may also determine whether the material in the region 506 is a proper target for laser ablation (e.g., based on the type of the material in the region 506 and/or the distance to the material in the region 506).”).
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 LEI ZHANG whose telephone number is (571)272-7172. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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/L.Z./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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