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 .
Claim Status: Claims 1-15, 19-27, 29-33, 35-36, 39-53, 63, 70, 74, 82, 104, and 114 are pending. Claims 2-9, 26, 27, 43-48, 50-51, 53, 63, 70, 74, 82, 104, and 114 have been withdrawn from consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 15, 2025 has been entered.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitation “the imaging light source” on page 4 uses a different word for the claim element “a first light source”. Please amend “the imaging light source” to “the first light source” to keep the term consistent. Appropriate correction is required.
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, 10-15, 19-25, 29-33, 35-36, 39-42, 49, and 52 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.
Re Claims 1 and 36, the limitation “the image signal” on page 4 is indefinite, because it lacks antecedent basis.
Indefiniteness of the independent claims render their dependent claims indefinite.
Re Claims 1 and 36, the limitations “the first light source is configured to provide image data to the processor for use in imaging tissue” and “the imaging light source is configured to provide image data to the processor for use in imaging the patient’s tissue” are indefinite, because sufficient structure is not recited in order to perform the claimed function of “providing image data to the processor”. A light source alone cannot provide an image data.
Response to Arguments
Applicant's arguments filed December 15, 2025 have been fully considered but they are not persuasive.
Re Claims 1 and 36, On pages 15, 17, and 18 of the Remarks, 1) Applicant made an argument that Applicant’s system first requires (i) imaging a first portion of the patient’s tissue, then subsequently (ii) interrupting blood flow in a second portion of the patient’s tissue; and then subsequently (iii) cutting a third portion of the patient’s tissue, as recited in the claims. Applicant further argued that “the third light source is configured to break molecular bonds of the patient’s tissue after the second light source is incident upon the second portion of the patient’s tissue”. Applicant further made an argument that Wach is using an OCT probe to monitor an entirely different process that is described by the Applicant and does not teach the ordered steps of imaging, blood flow interruption and possible tissue cutting as recited in the claims and described in the specification. Applicant made an argument that Applicant’s system does not require the addition of a light absorber as Wach’s OCT system.
This argument has been considered but is not persuasive.
The claimed invention is a ----system claim not a method claim.
Additionally, the three light sources are claimed as follows:
a first light source coupled to an optical fiber configured to provide a signal for use in imaging tissue when the first light source is incident upon a first portion of the tissue wherein the first light source comprises an optical coherence tomography light source;
a second light source coupled to the optical fiber configured such that the second light source coagulates a second portion of the patient's tissue when the second light source is incident upon the second portion of the patient's tissue, wherein the second light source is configured to emit energy at a wavelength in a range of 350 nm to 2200 nm, wherein: the second portion of the patient's tissue is located within the three-dimensional region specified by the user interface of the patient's tissue;
a third light source coupled to the optics fiber configured such that the third light source breaks molecular bonds of the patient's tissue when the third light source is incident upon a third portion of the patient's tissue wherein:
the first light source is configured to provide image data to the processor for use in imaging tissue after positioning the second light source on the second portion of the patient's tissue and before breaking the molecular bonds of the patient's tissue with the third light source;
the second light source is configured to emit energy at an amplitude and frequency sufficient to modify at least the quaternary structure of tissue proteins in blood vessels without completely breaking a majority of the molecular bonds of the patient's tissue,
the third light source is configured to break molecular bonds of the patient's tissue after the second light source is incident upon the second portion of the patient's tissue;
wherein the third light source is a tunable semiconductor laser seeded fiber amplified source configured to emit energy at wavelength in a range of 1800 nm to 2200 nm.
As shown in the claim language above, there are no method steps of (i) imaging a first portion of the patient’s tissue, then subsequently (ii) interrupting blood flow in a second portion of the patient’s tissue; and then subsequently (iii) cutting a third portion of the patient’s tissue. Bolded claim languages are all intended use and are not method steps. The first light source is only required to be configured to provide imaging light, and it is not a sensor configured to provide image data to a processor. Claim language of “after positioning the second light source … and before breaking the molecular bonds … with the third light source” is merely an intended use, and does not narrow the structure of “first light source”. Similarly, the second light source is only required to be configured to coagulate to a degree to modify at least the quaternary structure of tissue proteins in blood vessels without completely breaking a majority of the molecular bonds of the patient's tissue. However, the second light source is not required to coagulate a second portion of the patient’s tissue; it only needs to be capable of performing the function. Therefore, the location of the second portion of the patient’s tissue is also merely an intended use. Additionally, the second light source only needs to be configured to have to energy intensity that would coagulate by modifying the quaternary structure of tissue proteins in blood vessels without breaking the majority of the molecular bonds. It does not require to modify the quaternary structure of tissue proteins in blood vessels without breaking the majority of the molecular bonds, which is only an intended use. Also, modifying the quaternary structure of tissue proteins in blood vessels without breaking the majority of the molecular bonds doesn’t equate to “interrupting blood flow in a second portion of the patient’s tissue” as Applicant claims. Similarly, the third light source is only required to be capable of breaking molecular bonds. However, it does not require to “break molecular bonds of the patient’s tissue after the second light source is incident upon the second portion of the patient’s tissue”, which is only an intended use.
Applicant’s argument that Applicant’s system does not require the addition of a light absorber as Wach’s OCT system is not persuasive. The transitional phrase of claims 1 and 36 is “comprising”; therefore, the claims are open-ended. Wach’s OCT system that uses a light absorber still reads on the claim.
2) On page 16 of the Remarks, Applicant made an argument that Cho’s disclosure of wavelengths for the second light source and the third light source don’t read on the claimed wavelengths.
This argument has been considered but is not persuasive.
The claim recites that the second light source is configured to emit energy at a wavelength in a range of 350 nm to 2200 nm.
In col. 5, lines 43-56 of Cho discloses a second light source configured to coagulate with a light having a wavelength ranging from 0.8 to 1.1 microns. Cho’s second light source is configured to emit a light at a wavelength that lies within the range of 350 nm to 2200 nm, and therefore reads on the claim limitation.
The claim recites that the third light source is configured to emit energy at wavelength in a range of 1800 nm to 2200 nm.
In col. 5, lines 43-56 of Cho discloses a third light source configured to cut tissue with a light having a wavelength ranging from 1.4 to 2.1 microns. Cho’s second light source is configured to emit a light at a wavelength that lies within the range of 1800 nm to 2200 nm, and therefore reads on the claim limitation.
3) On page 17 of the Remarks, Applicant made an argument that Cho does not teach or suggest coupling the laser light into a fiber optic bundle that is used for imaging and it does not teach coupling the light emission from the three lasers into a single optic fiber. Applicant further argued that Cho does not teach using a diagnostic beam that is used for controlling the light dosimetry (on/off) of the various laser sources.
This argument has been considered but is not persuasive.
As shown in fig. 10, three light sources 36a, 36b, 36c are all couple to fiber optics 12.
Col. 3, lines 5-20 of Cho discloses that fiber optics 12 is a single optical fiber.
Applicant’s argument that Cho does not teach using a diagnostic beam that is used for controlling the light dosimetry (on/off) of the various laser sources is not persuasive, because that feature is not claimed.
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
4) On pages 18 and 19 of the Remarks, Applicant made an argument that modifying Cho in view of Gannot, Wach, Webster, Grego, and Murphy-Chutorian is impermissible, as there is no motivation to combine or no reasonable expectation of success. Applicant argued that cited rational underpinning does not contemplate or address “an optical control module configured to receive output data from the processor, configured such that the processor directs the optics control module to: receive the image signal obtained from the imaging light source, wherein the image signal obtained from the imaging light source is used to orient or position the second light source and the third light source; control a pulse profile, a pulse energy and a pulse repetition rate of the third light source; and control at least one of the pulse profile, pulse energy and pulse repetition rate to adjust a tissue removal rate”.
This argument has been considered but is not persuasive.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Webster has been relied on to teach most of the limitations, except “adjusting a tissue removal rate”, which is taught by Murphy-Chutorian. Webster and Grego were relied on to provide motivation for modifying Cho as modified by Wach, the motivation being modifying the control parameters based on the feedback of imaging signals for good accuracy (Webster, para. [0421]), controlling the tissue removal efficiency (Webster, para. [0310]), providing accurate sub-surface imaging of highly scattering tissue with high spatial resolution in vivo by using OCT and using the imaging in conjunction with tissue ablation and coagulation (Grego, para. [0005], [0006], [0094], [0051]), and protecting the first light source from back-reflection and redirecting the reflected signal to the detector (Webster, para. [0327], [0075]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 10-15, 19-22, 28, 30, 31, 35, 36, 40-42, 49, and 52 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (US 5,451,221), hereinafter “Cho”, as evidenced by Gannot et al. (US 2006/0052661), hereinafter “Gannot”, in view of Wach (US 2016/0062009), Webster et al. (US 2012/0138586), hereinafter “Webster”, Grego et al. (US 2012/0080612), hereinafter “Grego”, and Murphy-Chutorian et al. (US 2002/0042639).
Re Claims 1 and 31, Cho discloses a system comprising:
a first light source (col. 5, lines 43-56, Laser source 36c) coupled to an optical fiber (As shown in fig. 10, three light sources 36a, 36b, 36c are all coupled to fiber optics 12; Col. 3, lines 5-20, fiber optics 12 is a single optical fiber) configured to provide a signal for use in imaging tissue when the first light source is incident upon a first portion of the tissue (col. 5, lines 43-56, Laser source 36c generates light preferably having a wavelength ranging from about 632 nm to 670 nm at a power ranging between 1 to 5 milliwatts. This range of 60 wavelengths and power is suitable for targeting tissue.).
a second light source (col. 5, lines 43-56, Laser source 36b) coupled to the optical fiber (As shown in fig. 10, three light sources 36a, 36b, 36c are all coupled to fiber optics 12; Col. 3, lines 5-20, fiber optics 12 is a single optical fiber) configured such that the second light source coagulates a second portion of the patient's tissue when the second light source is incident upon the second portion of the patient's tissue (col. 2, lines 12-31, “A second laser source generates light of a second wavelength for coagulating tissue.”; col. 3, lines 22-37, “to coagulate prostate gland tissue so that bleeding does not occur when the tissue is cut”, col. 5, lines 25-42, “By simultaneously cutting and coagulating tissue, bleeding is minimized”), wherein: the second portion of the patient's tissue is located within the three-dimensional region specified by the user interface of the patient's tissue (Examiner notes that this is an intended use. Cho’s light source is capable of performing coagulation at a second portion of the patient’s tissue however the second portion is determined);
wherein the second light source is configured to emit energy at a wavelength in a range of 350 nm to 2200 nm (col. 5, lines 43-56, Laser source 36b generates light having a wavelength ranging from 0.8 to 1.1 microns);
a third light source (col. 5, lines 43-56, Laser source 36a) coupled to the optics fiber (As shown in fig. 10, three light sources 36a, 36b, 36c are all coupled to fiber optics 12; Col. 3, lines 5-20, fiber optics 12 is a single optical fiber) configured such that the third light source breaks molecular bonds of the patient's tissue when the third light source is incident upon a third portion of the patient's tissue wherein: the third light source is configured to break molecular bonds of the patient's tissue after the second light source is incident upon the second portion of the patient's tissue (col. 2, lines 12-31, “a first laser source for generating light of a first wavelength for cutting tissue”; col. 3, lines 22-37; col. 5, lines 25-42; Examiner notes that “after the second light source is incident upon the second portion of the patient's tissue” is an intended use, and Cho’s laser source 36a is capable of performing the function.),
wherein the third light source is configured to emit energy at wavelength in a range of 1800 nm to 2200 nm (col. 5, lines 43-56, Laser source 36a generates light having a wavelength ranging from 1.4 to 2.1 microns).
Cho does not expressly use the language of the second light source being configured to emit energy at an amplitude and frequency sufficient to modify at least quaternary structure of tissue proteins in blood vessels without completely breaking a majority of the molecular bonds of the tissue. However, modification of at least quaternary structure of tissue proteins without completely breaking a majority of the molecular bonds of the tissue is what is happening in coagulation.
Gannot discloses biological implications based on the degree of laser-induced heating (para. [0023]) and teaches that 60 degrees Celsius induces permanent denaturation of proteins and collagen leading to tissue coagulation and shrinkage generally in blood vessels (para. [0023]). It also teaches that 60 degrees Celsius used for tissue coagulation does not completely break a majority of the molecular bonds of the tissue, where the breaking of the majority of the molecular bonds of the tissue occurs at a higher temperature of 100 degrees Celsius where water molecules start to vaporize and cavitation bubbles cause ruptures and thermal decomposition of tissue fragments, whereby adjacent tissue is preserved (para. [0023]).
Given the mechanism of how the coagulation works, Cho’s coagulation would perform the function of modifying at least quaternary structure of tissue proteins in blood vessels without completely breaking a majority of the molecular bonds of the tissue.
Examiner notes that the limitation “a first light source configured to provide a signal for use in imaging tissue when the first light source is incident upon tissue” is an intended use. There is no structure in this limitation that performs the imaging of tissue or delivers light to an imaging device.
Cho is silent regarding the third light source being a tunable semiconductor laser seeded fiber amplified source configured to emit energy at wavelength in a range of 1800 nm to 2200 nm.
Cho is silent regarding wherein the first light source comprises an optical coherence tomography light source, wherein the first light source is configured to provide image data to the processor for use in imaging tissue after positioning the second light source on the second portion of the patient's tissue and before breaking the molecular bonds of the patient's tissue with the third light source.
However, Wach discloses a light source configured to break molecular bonds of the tissue when the light source is incident upon a portion of the tissue (para. [0316], [0321], [0325], tissue cutting) and teaches that the light source is a tunable semiconductor laser seeded fiber amplified source configured to emit energy at a wavelength in a range of 1800 nm to 2200 nm (para. [0319], The infrared laser 2505 can be a semiconductor laser, an eximer laser, a tunable laser, or a gas laser, for example. In one exemplary embodiment, the infrared laser 2505 is a Nd:YAG laser or some other laser that outputs light between about 600 nanometers and 3,500 nanometers.; para. [0073], [0074] discloses silicon optical amplifier, erbium doped fiber amplifier, and erbium doped waveguide amplifier which further provide active manipulation of light).
Wach further discloses that the tip of the surgical handpiece can comprise optical coherence tomography to provide images for viewing by the surgeon or sensor data for automatic feedback control where the monitoring information can feedback to the microprocessor for controlling light and/or ink delivery (para. [0321]), which reads on “the first light source comprises an optical coherence tomography light source, wherein the first light source is configured to provide image data to the processor for use in imaging tissue after positioning the second light source on the second portion of the patient's tissue and before breaking the molecular bonds of the patient's tissue with the third light source”. Examiner notes that the language “after positioning the second light source on the second portion of the patient's tissue and before breaking the molecular bonds of the patient's tissue with the third light source” is an intended use, and Wach’s OCT system is configured to provide image data to the processor for use in imaging tissue and capable of performing the function in the specific timing.
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Cho, by configuring the light source to be a tunable semiconductor laser seeded fiber amplified source configured to emit energy at a wavelength in a range of 1800 nm to 2200 nm, and configuring the first light source to comprise an optical coherence tomography light source, wherein the first light source is configured to provide image data to the processor for use in imaging tissue after positioning the second light source on the second portion of the patient's tissue and before breaking the molecular bonds of the patient's tissue with the third light source, as taught by Wach, for the purpose of limiting the depth of the tissue that is cut by the laser light such that non-targeted tissue wouldn’t be damaged (para. [0311]-[0317]) and controlling light and/or ink delivery and viewing of the surgical site by the surgeon (para. [0321]).
Cho and Wach are silent regarding the first light source configured as a broadband optical coherence tomography light source.
Cho and Wach are silent regarding an optical control module configured to receive output data from the processor, configured such that the processor directs the optics control module to: receive the image signal obtained from the imaging light source, wherein the image signal obtained from the imaging light source is used to orient or position the second light source and the third light source; control a pulse profile, a pulse energy and a pulse repetition rate of the third light source; and control at least one of the pulse profile, pulse energy and pulse repetition rate to adjust a tissue removal rate.
Cho and Wach are silent regarding a user interface communicatively coupled to a processor, wherein the user interface is configured to: display examination images of the patient’s tissue obtained with the first light source; and specify a three-dimensional region of the patient’s tissue for removal.
Webster discloses systems for coherent imaging and feedback control for cutting biological tissue (para. [0071], [0144], [0146], [0181], [0322], [0324], [0326], [0333], [0340]) and teaches that the first light source comprising an optical coherence tomography light source (fig. 1, imaging optical source 18, imaging light 20, optical interferometer 22, interferometry output 24; para. [0168], fig. 24, [0265], [0298], [0319], [0358], medical imaging field, para. [0411], [0424]) and that the first light source configured as a broadband optical coherence tomography light source (para. [0257], [0343], [0345], [0349], broadband source).
Webster further teaches an optical control module (para. [0024], a feedback controller) configured to receive output data from a processor (para. [0023], interferogram processor), configured such that the processor directs the optics control module to: receive the image signal obtained from the imaging light source (para. [0024], the feedback controller performs an analysis based on the interferometry output and generates feedback control that controls depth cutting relative to an interface that is closest to the cutting laser), wherein the image signal obtained from the imaging light source is used to orient or position the other light source (para. [0254], control parameters based on their positions; para. [0009], a feedback controller that controls at least one processing parameter of the material modification process based on the interferometry output, para. [0010], [0011], [0012]-[0015], [0017], [0022]-[0027], feedback controller that controls depth cutting based on depth measurement, [0028], [0034], [0035], [0065], [0147]-[0151], [0173]-[0178], [0190]-[0198]; para. [0007], [0027], focal position of the beam, [0052], [0080], [0104], [0174], [0212], [0246], [0254], [0260]); and control a pulse profile, a pulse energy and a pulse repetition rate of the third light source (para. [0426], control parameters, claim 125, pulse repetition rate of the beam, pulse energy of the beam, pulse shape of the beam; para. [0007], [0027], [0052], [0080], [0104], para. [0200]-[0212]).
Webster further discloses applying a material processing beam to at least one of: hard biological tissue and soft biological tissue (para. [0071], [0143], [0181]) and teaches that at least one of the pulse profile, pulse energy, and pulse repetition rate can be controlled to adjust a tissue removal efficiency (para. [0310], Increased material removal efficiency is observed by increasing the repetition rate of the ablation laser source. Pulses with half the energy but twice the repetition rate are more effective at ablation than pulses with twice the energy but half the repetition rate; para. [0396], An ICI system can control the rate of perforation by signaling a change in process parameters (e.g. pulse energy) based on the processed interferometry signals it measures; para. [0309], Once cutting is initiated, material removal was approximately linear with pulse number).
Additionally, Grego teaches optical coherence tomography used for endoscopic observation (para. [0004], para. [0035]-[0041]) and teaches that OCT provides subsurface imaging with high spatial resolution within a depth range of 1 to 4 mm in vivo with no need for fluorescent labeling of the tissue. OCT has been demonstrated to provide accurate sub-surface imaging of highly scattering tissues in the mucosa of gastrointestinal, respiratory, and urogenital tracts as well as in the oral cavity and in the endothelium of vascular tissue. The imaging capabilities of OCT permits accurate non-invasive diagnosis and staging of cancers and other pathologies that heretofore have been difficult to diagnose at an early stage because of relatively poor visualization available with white light endoscopy (para. [0005], [0006]).
Webster further discloses a user interface (para. [0345], image display) communicatively coupled to a processor, wherein the user interface is configured to: display examination images of the patient’s tissue obtained with the first light source; and specify a three-dimensional region of the patient’s tissue for removal (para. [0345], the spectral interferogram data is passed to electronic processing which generates the electronic feedback control for the surgical laser and robotic controlled focusing head. In addition, an output is generated for an image display. Para. [0346], The surgeon can use the image display to image the target area (and below) before he/she starts the surgical laser. The imaging system can also be used to fine tune the position of the surgical laser using co-registration with other imaging modalities. This would allow the surgeon to look at a small volume of the treatment area in real-time using the ICI, inline coherent imaging, in the context of larger anatomical features).
Additionally, Grego further discloses a user interface, wherein the user interface is configured to allow a user to: display examination images of the patient’s tissue obtained with the first light source; and specify a three-dimensional region of the patient’s tissue for removal (para. [0007], [0008], [0036], OCT providing a 3D volumetric image; para. [0006], A computer system performs the processing steps of image acquisition, analysis and display).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Cho as modified by Wach, by configuring the first light source to be as a broadband optical coherence tomography light source and adding an optical control module configured to receive output data from the processor, configured such that the processor directs the optics control module to: receive the image signal obtained from the imaging light source, wherein the image signal obtained from the imaging light source is used to orient or position the second light source and the third light source; control a pulse profile, a pulse energy and a pulse repetition rate of the third light source, and control at least one of the pulse profile, pulse energy, and pulse repetition rate to adjust a tissue removal efficiency, as taught by Webster, for the purpose of modifying the control parameters based on the feedback of imaging signals for good accuracy (Webster, para. [0421]), controlling the tissue removal efficiency (Webster, para. [0310]), providing accurate sub-surface imaging of highly scattering tissue with high spatial resolution in vivo by using OCT and using the imaging in conjunction with tissue ablation and coagulation (Grego, para. [0005], [0006], [0094], [0051]), and protecting the first light source from back-reflection and redirecting the reflected signal to the detector (Webster, para. [0327], [0075]).
Furthermore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Cho as modified by Wach, Webster, and Grego, by adding a user interface, wherein the user interface is configured to allow a user to: display examination images of the patient’s tissue obtained with the first light source; and specify a three-dimensional region of the patient’s tissue for removal, as taught by Webster and Grego, for the purpose of using the image display to image the target area (and below) before he/she starts the surgical laser (Webster para. [0346]).
Webster discloses at least one of the pulse profile, pulse energy, and pulse repetition rate can be controlled to adjust a tissue removal efficiency (para. [0310], Increased material removal efficiency is observed by increasing the repetition rate of the ablation laser source. Pulses with half the energy but twice the repetition rate are more effective at ablation than pulses with twice the energy but half the repetition rate; para. [0396], An ICI system can control the rate of perforation by signaling a change in process parameters (e.g. pulse energy) based on the processed interferometry signals it measures; para. [0309], Once cutting is initiated, material removal was approximately linear with pulse number); however, Webster is silent regarding at least one of the pulse profile, pulse energy and pulse repetition rate can be controlled to adjust a tissue removal rate.
However, Murphy-Chutorian discloses a method for non-synchronous laser-assisted myocardial revascularization and teaches at least one of the pulse profile, pulse energy, and pulse repetition rate can be controlled to adjust a tissue removal rate (para. [0047], The average power Pav of a repetitively pulsed laser is equal to the energy per pulse times the number of pulses per unit time (Pav =joules/pulse × pulses/second, in watts). The number of tissue parcels ablated per second is equal to the repetition rate of the laser in pulses per second, or hertz. Thus, increasing the pulse repetition rate to increase the average power delivered to the tissue linearly increases the rate of tissue removal.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Cho as modified by Wach, Webster, and Grego, by controlling at least one of the pulse profile, pulse energy and pulse repetition rate to adjust a tissue removal rate, as taught by Murphy-Chutorian, for the purpose of adjusting a tissue removal rate (para. [0047]).
Re Claims 36 and 52, Claims 36 and 52 are rejected under substantially the same basis as Claim 1.
Re Claim 10, Cho discloses that the third light source is configured to break molecular bonds of the tissue coagulated by the second light source when the third light source is incident upon tissue (col. 2, lines 12-31, col. 5, lines 25-42; col. 4, line 66 – col. 5, line 15).
Re Claim 49, Claim 49 is rejected under substantially the same basis as Claim 10.
Re Claim 11, Cho discloses that the third light source is configured to alter the quaternary structure of proteins of the tissue when the third light source is incident upon the tissue (col. 2, lines 12-31, “a first laser source for generating light of a first wavelength for cutting tissue”; col. 5, lines 16-42: light configured to cut tissue will alter the quaternary structure of proteins of tissue).
Re Claim 12, Cho discloses that the first light source, the second light source and the third light source emit light through a single fiber at the same instance (abstract, “A single optical fiber or a bundle of optical fiber can be used to transmit plural wavelengths of light for aiming cutting and coagulating”; col. 2, lines 12-31, col. 4, line 66 – col. 6, line 5).
Re Claim 13, Cho discloses that the single fiber is a component of an endoscope or laparoscope (abstract, fig. 1, col. 3, “endoscopic light delivery system 10 includes a laser source 36 for generating light which is optically coupled to fiber optics 12.”).
Re Claim 14, Cho discloses that the first light source, the second light source, and the third light source emit light through a single fiber at different times (abstract, “A single optical fiber or a bundle of optical fiber can be used to transmit plural wavelengths of light for aiming cutting and coagulating”; col. 4, line 66 – col. 6, line 5, “Alternatively, light generated by laser sources 36a, 36b and 36c does not have to be conveyed by fiber optics 12 simultaneously but can be conveyed sequentially”).
Re Claim 15, Cho discloses that the single fiber is a component of an endoscope or laparoscope (abstract, fig. 1, col. 3, “endoscopic light delivery system 10 includes a laser source 36 for generating light which is optically coupled to fiber optics 12.”).
Re Claims 19 and 20, Cho discloses that the second light source is a laser that emits energy in a range of wavelengths that are absorbed by blood, wherein the blood comprises a mixture of oxy-hemoglobin, deoxy-hemoglobin and water (col. 2, lines 12-31, the second laser source has a wavelength of approximately 0.8 to 1.1 microns).
Re Claim 21, Cho discloses that the second light source is a laser that emits energy in a range of wavelengths that are absorbed by blood, wherein the blood contains hemoglobin that comprises pure oxy-hemoglobin (col. 2, lines 12-31, the second laser source has a wavelength of approximately 0.8 to 1.1 microns).
Re Claim 22, Cho discloses that the second light source is a laser that emits energy in a range of wavelengths that are absorbed by blood, wherein the blood contains hemoglobin that comprises pure deoxy-hemoglobin (col. 2, lines 12-31, the second laser source has a wavelength of approximately 0.8 to 1.1 microns).
Re Claim 30, Cho as modified by Wach, Webster, Grego, and Murphy-Chutorian discloses the claimed invention substantially as set forth in Claim 1.
Cho is silent regarding the first light source being configured as a swept source optical coherence tomography light source.
However, Grego discloses an endoscopic optical coherence tomography (OCT) system coupled to surgical probes (para. [0092], [0093], [0094], fig. 1C, fig. 2). Grego teaches imaging light source being configured as a swept source optical coherence tomography light source (para. [0006]), for the purpose of capturing images of different depths of the tissue (para. [0006]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Cho as modified by Wach, Webster, Murphy-Chutorian and Grego, to add a swept source optical coherence tomography light source as a part of the first light source, as well as incorporating the OCT system, as taught by Grego, for the purpose of capturing images of different depths of the tissue (para. [0006]).
Re Claim 35, Cho discloses that the third light source is a laser configured to emit energy at an amplitude and frequency sufficient to break molecular bonds of tissue (col. 2, lines 12-31, “a first laser source for generating light of a first wavelength for cutting tissue”; col. 4, line 66 – col. 6, line 5, “Laser source 36a generates light preferably having a wavelength ranging from about 1.4 to 2.1 microns which is a wavelength suitable for cutting tissue”).
Re Claim 40, Cho discloses that the coagulating light and the bond-breaking light originate from a common light source (col. 3, lines 5-21, a laser source 36 providing light for both cutting tissue and coagulating tissue).
Re Claims 41 and 42, Cho as modified by Wach, Webster, and Grego discloses the claimed invention substantially as set forth in claims 36 and 40.
Cho discloses that the wavelength for coagulation is 0.8 to 1.1 micron and the light source may be a diode laser, and the wavelength for cutting tissue may be 1.4 to 2.1 micron and may be a Nd YAG laser (col. 5), where Nd:YAG lasers are optically pumped using a flashtube or laser diodes.
Cho is silent regarding the common light source being a diode laser seeded fiber amplified source and wherein the diode laser seeded amplified source is configured to emit energy in a range of wavelengths from 1800 nm to 2200 nm.
However, Wach discloses a light source configured for ablation, incision, cutting, vaporization, and removal of tissue (para. [0316], [0321], [0325], [0329], tissue cutting) and teaches a diode laser seeded amplified source is configured to emit energy in a range of wavelengths from 1800 nm to 2200 nm (para. [0319], The infrared laser 2505 can be a semiconductor laser, an eximer laser, a tunable laser, or a gas laser, for example. In one exemplary embodiment, the infrared laser 2505 is a Nd:YAG laser or some other laser that outputs light between about 600 nanometers and 3,500 nanometers.; para. [0073], [0074] discloses silicon optical amplifier, erbium doped fiber amplifier, and erbium doped waveguide amplifier which further provide active manipulation of light).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Cho as modified by Wach, Webster, Murphy-Chutorian and Grego, by configuring the common light source to be a diode laser seeded fiber amplified source that is configured to emit energy in a range of wavelengths from 1800 nm to 2200 nm, as taught by Wach, for the purpose of having a laser configured to produce various wavelengths (para. [0089]) and managing light flow at the various optical interface (para. [0318], [0156], [0074]).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (US 5,451,221), hereinafter “Cho”, as modified by Wach (US 2016/0062009), Webster et al. (US 2012/0138586), hereinafter “Webster”, Murphy-Chutorian et al. (US 2002/0042639), and Grego et al. (US 2012/0080612), hereinafter “Grego”, and further in view of Wells et al. (US 8,202,268), hereinafter “Wells”.
Re Claim 25, Cho as modified by Wach, Webster, Murphy-Chutorian and Grego discloses the claimed invention substantially as set forth in claim 1, but is silent regarding the third light source being a Tm doped fiber master oscillator power amplifier.
However, Wells discloses an apparatus using a high-power, short-pulsed thulium laser to output infrared laser pulses delivered through an optical fiber, for cutting and ablating biological tissue (abstract), and teaches a Tm doped fiber master oscillator power amplifier (MOPA) (col. 21, lines 25-50, col. 27-29).
At the time of filing, it would have been obvious to one of ordinary skill in the art to modify Cho’s third light source configured to break molecular bonds of tissue to include Well’s MOPA, because such a modification is the result of simple substitution of one known element for another producing a predictable result. More specifically, Cho’s third light source and Well’s MOPA perform the same general and predictable function, the predictable function being breaking molecular bonds of tissue (or ablate or cut). Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself – that is in the substitution of Cho’s third light source by replacing it with Well’s MOPA. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claims 23, 24, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (US 5,451,221), hereinafter “Cho”, as modified by Wach (US 2016/0062009), Webster et al. (US 2012/0138586), hereinafter “Webster”, Murphy-Chutorian et al. (US 2002/0042639), and Grego et al. (US 2012/0080612), hereinafter “Grego”, and further in view of Goell et al. (US 2007/0053640), hereinafter “Goell”.
Re Claims 23, 24, and 29, Cho as modified by Wach, Webster, Murphy-Chutorian and Grego discloses the claimed invention substantially as set forth in claim 1.
Cho is silent regarding the second light source being a ytterbium fiber laser, or a frequency-doubled ytterbium fiber laser. Cho is also silent regarding the second light source being configured to emit energy in a range of wavelengths including 532 nm.
However, Goell discloses an endoscopic system (para. [0017]) comprising a first light source configured to provide a signal for use in imaging tissue when the first light source is incident upon tissue (para. [0150]); a light source configured to coagulate and ablate tissue when the second light source is incident upon tissue (para. [0161], fig. 6A, laser 510, laser systems 500 or 600 can be used for surgical procedures requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue). Goell teaches that the light source configured to coagulate tissue is an ytterbium fiber laser (para. [0086]), a frequency-doubled ytterbium fiber laser (para. [0086], [0147] – to provide radiation in the green visible light spectrum and can be used for photoablation and photocoagulation), and configured to emit energy in a range of wavelengths that produces green-visible light (para. [0086], [0147].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing, to modify Cho’s second light source configured to coagulate tissue, to include Goell’s an ytterbium fiber laser, a frequency-doubled ytterbium fiber laser, or a coagulation light source configured to emit energy in green-visible light spectrum, because such a modification is the result of simple substitution of one known element for another producing a predictable result. More specifically, Cho’s second light source and Goell’s light source perform the same general and predictable function, the predictable function being coagulation of tissue. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself – that is in the substitution of Cho’s second light source by replacing it with Goell’s light source. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Also, it would have been obvious to one of ordinary skill in the art, to modify the green-visible light spectrum of the second light source in Cho modified by Wach, Webster, Murphy-Chutorian, Grego, and Goell, to be in a range of wavelengths including 532 nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 32, 33, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Cho et al. (US 5,451,221), hereinafter “Cho”, as modified by Wach (US 2016/0062009), Webster et al. (US 2012/0138586), hereinafter “Webster”, Murphy-Chutorian et al. (US 2002/0042639), and Grego et al. (US 2012/0080612), hereinafter “Grego”, and further in view of Marchitto et al. (US 2002/0016533), hereinafter “Marchitto”.
Re Claims 32 and 33, Cho as modified by Wach, Webster, Murphy-Chutorian, and Grego discloses the claimed invention substantially as set forth in Claim 1.
Cho is silent regarding the first light source comprising a multiphoton luminescence light source, or the first light source comprising an optical coherence tomography light source and a multiphoton luminescence light source.
However, Marchitto discloses an endoscopic device with a light source for imaging, OCT system, and a light source for laser treatment (para. [0065], [0052], [0053], [0055], [0068], [0069]; [0039], [0055], [0064], para. [0008]). Marchitto teaches light source being configured as a broadband optical coherence tomography (OCT) light source (claim 9 and 21, para. [0034], [0035], fig. 2), for the purpose of collecting information on HbO2 and Hb as well as information as a function of depth in the sample and visualizing blood vessels below other normally appearing intervening structures that reduce or eliminate the ability to visualize the vessels (para. [0035]). Marchitto teaches the light source comprising a multiphoton luminescence light source (para. [0018], fig. 5, para. [0039]) for the purpose of gathering absorption and scattering imaging information and determining the location of the blood by capturing and comparing white light and infrared images (para. [0039] and [0040]). Marchitto teaches the first light source comprising an optical coherence tomography light source, for the purpose of not requiring an illumination source with a long coherence length (e.g., a laser) and for the purpose of being used with optical fibers and by using several wavelengths of light sequentially, being able to obtain specific images of arteries and veins, as well as a non-invasive measurement of blood oxygen saturation in a particular imaged vessel, and a multiphoton luminescence light source (para. [0039]-[0042]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing to modify Cho as modified by Wach, Webster, Murphy-Chutorian and Grego, by adding a broadband optical coherence tomography light source and a multiphoton luminescence light source as a part of the first light source, as well as incorporating the OCT and multiphoton imaging systems, as taught by Marchitto, for the purpose of by using several wavelengths of light sequentially, being able to obtain specific images of arteries and veins, as well as a non-invasive measurement of blood oxygen saturation in a particular imaged vessel, in case of OCT, and for the purpose of gathering absorption and scattering imaging information and determining the location of the blood by capturing and comparing white light and infrared images, in case of multiphoton imaging (para. [0039]-[0042]).
Re Claim 39, Claim 39 is rejected under substantially the same basis as claims 32 and 33.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mathis et al. (US 5,599,341): col. 6, lines 4-19 – tissue coagulation denatures proteins.
Joos et al. (US 20120310042) – endoscopic device with OCT and laser treatment
Mahadevan-Jansen (US 2014/0140594A1) discloses methods and systems for three-dimensional real-time intraoperative surgical margin evaluation of tumor tissues
Izatt (US 2003/0004412A1) discloses an optical circulator, wherein the imaging light source is configured to direct light through the optical circulator (fig. 19, para. [0231], optical circulator 136 is provided along the path of the first single mode fiber 3 (SMF) in fig. 6; para. [0232], Optical circulator 136 can transmit light, with low damping, only in two directions from SMF 137 to SMF 138, and from SMF 138 to SMF 139. The optical circulator cuts off light transmission in other directions.).
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, January 8, 2026
Examiner, Art Unit 3792