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 Arguments
Applicant’s arguments filed 7/21/2026 (“Applicant’s Remarks”) with respect to the rejection of Independent Claim under 35 U.S.C. 103 as being unpatentable over to US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”), US 2012/0283804 A1 to Kang et al. (“Kang”) and US 6004314 A to Wei et al. (“Wei”) have been fully considered but are not persuasive.
Applicant argues that the combination of Diao, Uchiyama, Kang and Wei “taken either singly or in combination, teaches or suggests a photoanalyzer configured to ‘determine, using the return laser light, a distance between a distal end of the laser probe and the retinal surface’ and ‘estimate, using the return laser light, a laser light absorption in the retina,’ where the system is configured to ‘use the determined distance and the estimated laser light absorption to adjust a power, pulse duration, pulse frequency, or treatment time of the laser source,’ as recited by Claim 16.” (Applicant’s Remarks at Pg. 7). Applicant appears to agree with the Examiner’s characterization of Diao (Applicant’s Remarks at Pg. 8, “The Office Action acknowledges these deficiencies….”), but disagrees that Uchiyama, Kang and Wei remedy Diao’s deficiencies.
Diao teaches such a “laser source” and “multi-spot laser probe” as claimed, but does not teach the claimed methodology for laser source adjustment or its associated electromechanical components. Uchiyama, Kang and Wei add the components and adjustment methodology which Diao lacks. It would have been obvious for a person of ordinary skill in the art to combine the prior art elements found in Diao, Uchiyama, Kang and Wei according their known functions to arrive at the invention of Claim 16.
Applicant’s arguments address the teachings of individual references without respect to the proposed combination, and as such mischaracterize the modifications that one of ordinary skill in the art would be likely to make. “The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time.” MPEP 2141(II)(C). “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420, 82 USPQ2d at 1397. “Office personnel may also take into account ‘the inferences and creative steps that a person of ordinary skill in the art would employ.’” MPEP 2141(II)(C), quoting KSR at 418, 82 USPQ2d at 1396. The level of ordinary skill is quite high, which informs the type of modifications an ordinary artisan would consider. One of ordinary skill in the art would be well aware of the concept of laser adjustment based on feedback, and would understand optical coherence tomography as a common means for obtaining pertinent information.
With respect to Applicant’s arguments regarding Uchiyama, Applicant argues that “Uchiyama … analyzes return observation light generated by low-coherence light source 101, not return laser light from the multiple retinal-treatment beams generated by Diao's laser source 105” (Applicant’s Remarks at Pg. 8). The Examiner respectfully disagrees that one of ordinary skill in the art would be motivated to use return light other than Diao’s laser light in conjunction with Uchiyama’s photoanalyzer. Such a modification as proposed by Applicant would require the introduction of light not present in Diao for no ostensible benefit. A person of ordinary skill in the art would look to Uchiyama for its teaching of specific electromechanical means for obtaining information of scattered light from a subject, and in so-doing would identify Uchiyama’s “detectors 291a and 291b” (i.e., a “photoanalyzer”) and “optical circulator 293” as pertinent. Optical coherence tomography would be a known concept to the ordinary artisan, and as such–via “the inferences and creative steps that a person of ordinary skill in the art would employ”–he would see fit to modify Diao’s probe using Uchiyama’s components. While Uchiyama indeed does not describe “return laser light from the multiple retinal-treatment beams generated by Diao's laser source 105,” capturing and measuring such returned light is fundamental principle of optical coherence tomography. One of ordinary skill would understand “return laser light from the multiple retinal-treatment beams generated by Diao's laser source 105” to be readily amenable to such use, and would not be motivated to add an additional light source in the manner Applicant’s arguments suggest.
Pertinently, the Examiner notes that Diao’s probe is used to provide treatment. See Diao at Para. [0003]. As such, it is the only device producing any sort of light. It is not clear how Applicant’s proposed modification fits within Diao’s configuration.
Applicant’s arguments regarding Kang and Huang similarly disregard the proposed modification and level of ordinary skill, and additionally understate the breadth of Claim 16.
Applicant first argues that “Kang separately provides optical fiber 112 as an OCT probe for determining a distance to a tissue surface, and motorized platform 108 may move mid-infrared laser 104 and light pipe 106 to maintain a substantially constant distance from that surface” and “thus determines distance using separate OCT probe 112 and OCT light, not using treatment laser light emitted through and returned through light pipe 106” (Applicant’s Remarks at Pg. 8). But Kang’s proposed teaching is “to configure the photoanalyzer of Diao as modified by Uchiyama so that it performs such OCT-derived distance determination as taught by Kang” (see Non-Final Office Action dated 5/12/2026 at Para. 19). Again, optical coherence tomography would be a known concept to the ordinary artisan, and as such–via “the inferences and creative steps that a person of ordinary skill in the art would employ”–he would see fit to modify Diao’s device as previously-modified to include Uchiyama’s photoanalyzer such that it is configured to make a similar distance determination as Kang describes. The ordinary artisan would not view such a modification to require a separate OCT system as Applicant suggests.
Applicant argues second that “Kang and Huang do not cure the deficiency concerning the absorption estimation” because “Huang does not state that an OCT distance measurement necessarily estimates the absorption of treatment laser light by the retina” (Applicant’s Remarks at Pg. 9). This argument misstates the Examiner’s position. The Examiner states with reference to Huang at Para. 18(b)(i) of the Non-Final Office Action dated 5/21/2026 that “[s]uch estimation is implicit in Kang’s use of optical coherence tomography,” not that “an OCT distance measurement necessarily estimates the absorption of treatment laser light by the retina.” The Examiner cites Huang as evidence of the level of ordinary skill with respect to OCT, and more specifically to evidence that the level of ordinary skill would include the understanding that such OCT as used by Kang it Kang’s distance determination is done by quantifying reflection. The Examiner then states that quantifying reflection is a means of estimating absorption (because light is either reflected or absorbed), and cited Para. [0021] of the Present Specification in support of this position (See Present Specification at Para. [0021], “During laser titration according to methods set for herein, laser light absorption in the retina is estimated based on laser light reflection…”). The Examiner’s position is that Kang’s use of OCT estimates absorption in precisely the same manner as does the claimed invention.
Applicant further argues that “The Office Action does not explain how the reflection or backscattering measurements described by Kang or Huang would yield the claimed absorption estimate, or identify any additional information or analysis used by Kang or Huang to make such an estimate” (Applicant’s Remarks at Pg. 9). The Examiner notes that Claim 16 contains no such requirement (Claim 16 as amended recites “estimate, using the return laser light, a laser light absorption…”), and that the Present Specification itself does not provide any such explanation. Regardless, Kang’s use of OCT estimates absorption in precisely the same manner as does the claimed invention.
The Examiner further notes the breadth of the photoanalyzer’s recited configuration. The terms “determine, using the return laser light…” and “estimate, using the return laser light…” are quite broad with respect to the required role of “the return laser light.” Similarly, the methodology for determining adjustments is quite broad with respect to the required role of “the determined distance” and “the estimated laser light.”
The Examiner notes that amendments which more explicitly define the “laser light” and “return light” may suffice to resolve the outstanding rejection. The rejection of Claim 30 herein under 35 USC 112(b) highlights this issue: it appears that these terms are intended to reference something other than the language of Claim 16 suggests.
Applicant’s arguments regarding dependent Claims 17-30 are based on Applicant’s arguments regarding Independent Claim 16. Applicant’s arguments have been fully considered but are not persuasive for the same reasons as explained above.
Applicant’s arguments regarding the rejection of Claims 16, 21, 23, 25, and 30 stand rejected under 35 U.S.C. § 112(b) as being indefinite have been fully considered and are persuasive. The Examiner agrees that the Present Amendments have resolved the cited indefiniteness issues. The rejection is withdrawn.
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 16 and 30, and Claims 17-29 by dependency, 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.
Regarding Claim 16, Claim 16 recites “wherein the system is configured to use….” It is unclear in what sense the manner in which the system is used limits the structure of apparatus claim 16. See MPEP 2173.05(p)(II).
The rejection could be overcome by amending Claim 16 to recited “wherein the system is configured to adjust a power, pulse duration, pulse frequency, or treatment time of the laser source based on the determined distance and the estimated laser light absorption.”
Regarding Claim 30, Claim 30 recites “an input configured to receive the laser light generated from the light laser source a first output configured to transmit a first portion of the laser light from the input to the first port of the optical circulator; and a second output configured to transmit a second portion of the laser light from the input to a fiber coupler, thereby bypassing the optical circulator, wherein the second portion of the laser light corresponds to a reference signal, and wherein the second portion of the laser light is combined with the return laser light at the fiber coupler for transmission to the photoanalyzer.” The use of the term “laser light” in Claim 30 appears inconsistent with its use in Claim 16. In Claim 16, “laser light” is defined only vicariously and as light which is able to “bounce[] off the retinal surface and return[] back into the multi-spot laser probe.” Yet the configuration of Claim 30 requires that this light never reaches the retinal surface. It is thus unclear in what sense Claim 30 further limits Claim 16, and it is unclear what configuration is contemplated by Claim 30.
For purposes of this Office Action, Claim 30 is being interpreted to reference light from the “a light source” of Claim 18.
The Examiner notes that this discrepancy with respect to the term “laser light” appears pertinent to the Examiner’s position regarding Applicant’s arguments. Clarification in this respect would likely advance prosecution.
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 16, 19, 21-23, 25-26 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”), US 2012/0283804 A1 to Kang et al. (“Kang”), and previously cited US 6004314 A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”). The rejection is maintained.
Regarding Independent Claim 16, Diao teaches:
An optical system, comprising: (Title, “Multi-fiber multi-spot laser probe with simplified tip construction;” Para. [0004]; Paras. [0030] through [0032]);
Paras. [0030] through [0032] details the probe alluded to in the Title as part of a broader system; Para. [0004] makes clear that the broader system is an optical system.
a laser source configured to provide multiple laser beams for a retinal laser treatment; (Para. [0032], “Returning to FIG. 1, it can be seen that a laser source 105 drives probe 100 through a suitable interconnect;” Para. [0040], “ GRIN lens 505 then focuses the beams on the retinal surface 520;” Para. [0019], “FIG. 5 illustrates a GRIN lens for angularly separating the projected multiple beams emitted from the multi-fiber array of FIG. 4;” Para. [0047]);
It is noted that Diao’s “GRIN lens 505” is part of Diao’s “laser source 105.” See Diao at Para. [0036].
Diao’s beams are used for retinal laser treatment. See Diao at Para. [0047], “Further, the point at which the beams converge, at a short working distance from the tip, can be used by surgeons to create a single treatment spot for certain procedures such as repair of retinal breaks and tears.”).
a multi-spot laser probe optically coupled to the laser source and configured to direct the multiple laser beams onto a retinal surface of a retina to create multiple laser spots, and wherein some of the laser light bounces off the retinal surface and returns back into the multi-spot laser probe; (Fig. 1, “multi-spot laser probe 100” is optically coupled to “laser source 105;” Para. [0032], “Returning to FIG. 1, it can be seen that a laser source 105 drives probe 100 through a suitable interconnect;” Figs. 6A and 6B; Para. [0046], “…the beams form a diverging spot pattern increasing in size and separation distance with increasing working distance from the distal end of cannula 600;” Para. [0033]).
The limitation “wherein some of the laser light bounces off the retinal surface and returns back into the multi-spot laser probe” is an inherent property of light. See, e.g., Huang at Pg. 1178, Left Column, Second Paragraph through Right Column, Third Paragraph, discussing such inherent reflection of light as the basis for optical coherence tomography.
Diao does not disclose:
a photoanalyzer;
and an optical circulator configured to direct the return laser light received from the retinal surface to the photoanalyzer;
wherein the photoanalyzer is configured to: determine, using the return laser light, a distance between a distal end of the laser probe and the retinal surface;
and estimate, using the return laser light, a laser light absorption in the retina;
and wherein the system is configured to use the determined distance and the estimated laser light absorption to adjust a power, pulse duration, pulse frequency, or treatment time of the laser source.
Uchiyama describes an “Optical scanning observation apparatus” (Title). Uchiyama is analogous art.
Uchiyama teaches:
a photoanalyzer; (Fig. 59, “detectors 291a and 291b”);
Uchiyama’s “detectors 291a and 291b” are such a “photoanalyzer” as claimed. See Para. [0045] of the Present Specification in support of this interpretation (“Photoanalyzer 216 generally includes a photodetector 230 for receiving the return light signals and a system controller 232 coupled to photodetector 230 for analyzing the return light signals in order to determine one or more spectral parameters of the targeted eye tissues/structures and other information.”).
an optical circulator configured to direct the return laser light received from the retinal surface to the photoanalyzer; (Fig. 59, “optical circulator 293;” Para. [0245], “…In FIG. 19, near-infrared low-coherence light irradiated from a low- coherence light source 101 is guided to a first optical fiber 106, and is branched into a third optical fiber 109 and a fourth optical fiber 110 by an optical coupler 108 having four input/output.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Diao with the teachings of Uchiyama (i.e., to additionally include such a photoanalyzer and optical circulator as taught by Uchiyama in the device of Diao) in order to enable the system to obtain information of scattered light from a subject, which information can be used for diagnostic purposes (Uchiyama at Paras. [0001] and [0002]).
Diao’s system includes such a probe and laser source as claimed, but Diao does not contemplate such analysis and adjustment components as claimed. Uchiyama remedies certain of Diao’s deficiencies in that Uchiyama teaches an apparatus for creating a tomographic image using scattered light via the particular mechanical components recited by Claim 16. Uchiyama’s described manner of creating the tomographic image is consistent with certain of the analysis components recited by Claim 16 as alluded to above. Ideologically, the proposed modification entails altering Diao’s “bare” probe and laser such that it is capable Uchiyama’s described tomographic imaging. From a technical standpoint, that modification entails the inclusion of such a “photoanalyzer” and “optical circulator” as taught by Uchiyama as structural means for accomplishing this. One of ordinary skill in the art would be motivated to make such a modification for the same benefit as Uchiyama describes at Paras. [0001] and [0002].
Kang describes “…a method of intraocular laser therapy…” (Para. [0019]). Kang is analogous art.
Kang uses optical coherence tomography to sense distance between a probe tip and a retinal surface
Kang teaches:
wherein the photoanalyzer is configured to: determine, using the return laser light, a distance between a distal end of the laser probe and the retinal surface; (Para. [0021], “A combined optical coherence tomography (OCT) and motor control system can control the distance of the probe tip and the retina surface with an accuracy of around 1 micron;” Para. [0028], “The optical fiber 112 can be a probe for an OCT system, for example, to determine a distance to a surface of tissue to be irradiated;” );
and estimate, using the return laser light, a laser light absorption in the retina; (Para. [0021]; Para. [0028]);
Such estimation is implicit in Kang’s use of optical coherence tomography. See, e.g., Huang at Pg. 1178, Left Column, Second Paragraph (“An optical signal that is transmitted through or reflected from a biological tissue will contain time-of-flight information, which in turn yields spatial information about tissue microstructure.”); Huang at Pg. 1178, Right Column, Second Paragraph (“We have extended the technique of low-coherence reflectometry to tomographic im-aging in biological systems. In low-coherence reflectometry, the coherence property of light reflected from a sample provides information on the time-of-flight delay from the reflective boundaries and backscattering sites in the sample. The delay information is then used to determine the longitudinal location of the reflection sites.”). Quantifying reflection (at least in the manner done in optical coherence tomography) is a means of estimating absorption. See Present Specification at Para. [0021], (“During laser titration according to methods set for herein, laser light absorption in the retina is estimated based on laser light reflection…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao and Uchiyama with the teachings of Kang (i.e., to configure the photoanalyzer of Diao as modified by Uchiyama so that it performs such OCT-derived distance determination as taught by Kang) in order to facilitate precise laser targeting so as to avoid collateral thermal damages to surrounding retina tissues/layers during use (Kang at Para. [0008]).
Wei describes an “Optical coherence tomography assisted surgical apparatus” (Title). Wei is analogous art.
Wei teaches:
and wherein the system is configured to use the determined distance and the estimated laser light absorption are used to adjust a power, pulse duration, pulse frequency, or treatment time of the laser source. (Col. 12, Ln. 37-41, “In further embodiments, a measured volume of laser-treated tissue is used to control one or more of the following parameters: (a) for treatment laser 670; exposure time and power…”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao, Uchiyama and Kang with the teachings of Wei (i.e., to use the determined distance and laser light absorption as obtained by combined Diao, Uchiyama and Kang to adjust power or treatment time in the manner of Wei) in order to facilitate “controlling the extent of tissue change during the laser treatment and for controlling the tissue change based on laser power, exposure, and spot size” (Wei at Col. 3, Ln. 47-50).
Regarding Claim 19, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
Uchiyama additionally teaches:
wherein the return laser light comprises at least one of reflection, scattering, fluorescence, auto fluorescence, Raman spectra, or combinations thereof (Para. [0001], “The present invention relates to an optical scanning observation apparatus which creates a tomographic image of a subject based on information of scattered light from the subject…”).
Regarding Claim 21, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
Uchiyama additionally teaches:
wherein the photoanalyzer is configured to determine one or more spectral parameters based on at least one of light spectra of the return light, source light absorption, or source light scattering (Para. [0001], “The present invention relates to an optical scanning observation apparatus which creates a tomographic image of a subject based on information of scattered light from the subject…”).
Regarding Claim 22, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
Kang additionally teaches:
wherein: a light spectrum of the return light comprises at least one of intensity data, wavelength data, polarization data, phase data, or time of flight data, and the one or more spectral parameters are determined based on the light spectrum of the return light (Para. [0021]; Para. [0028]);
Kang inherently uses time of flight data by virtue of Kang’s use of OCT. See Huang at Pg. 1179, Left Column, First Paragraph.
Regarding Claim 23, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
Uchiyama additionally teaches:
further comprising: a first optical fiber coupled between the light source and a first port of the optical circulator; a second optical fiber coupled between a second port of the optical circulator and the multi-spot laser probe; and a third optical fiber coupled between a third port of the optical circulator and the photoanalyzer. (see Annotated Fig. 59, below):
PNG
media_image1.png
454
640
media_image1.png
Greyscale
Regarding Claim 25, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
Uchiyama additionally teaches:
further comprising an illumination source, (Fig. 59, “low-coherence light source 101”);
and a second optical fiber housed in the multi-spot laser probe, wherein illumination light from the illumination source is transmitted in the second optical fiber. (Fig. 59, “third optical fiber 109;” Para. [0251]).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Diao, Uchiyama, Kang and Wei (i.e., to include such an illumination source and second optical fiber configured in the manner of Uchiyama) in order to provide such reference light as forms the basis of the pertinent such information gathering for which one of ordinary skill in the art would be motivated to employ Uchiyama’s teachings in the manner explained above (see Uchiyama at Para. [0023]).
Regarding Claim 26, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
Kang additionally teaches
further comprising a memory storing executable instructions that cause the system to: determine a distance between a distal end of the probe and the body structure based on the return light; and generate an indication if the determined distance is below a threshold. (Para. [0028], “The optical fiber 112 can be a probe for an OCT system, for example, to determine a distance to a surface of tissue to be irradiated. The motorized platform 108 can be adapted to communicate with a motor control system that is adapted to communicate with the optical coherence tomography system such that the motorized platform 108 can be moved to maintain a substantially constant distance from a surface of tissue being irradiated;” Para. [0021]).
Kang maintains a constant distance, and thus generates an indication (i.e., distance adjustment) if Kang’s determined distance is below a threshold (i.e., below Kang’s constant distance).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”), previously cited US 2012/0283804 A1 to Kang et al. (“Kang”) and previously cited US6004314A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”) as applied to Claim 16 above, and further in view of US 2017/0112374 A1 to Hathaway et al. (“Hathaway”).
Regarding Claim 17, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
The combination of Diao, Uchiyama, Kang and Wei does not disclose:
wherein the photoanalyzer is further configured to determine one or more spectral parameters of wavelength, frequency, wavenumber, or photon energy of the return laser light.
Hathaway describes “A method … for determining the thickness of a retina” (Abstract) which is based on optical coherence tomography (Para. [0015]). Hathaway is analogous art.
Hathaway teaches :
wherein the photoanalyzer is further configured to determine one or more spectral parameters of wavelength, frequency, wavenumber, or photon energy of the return laser light (Para. [0014], “The frequency spectrum generated by the spectrometer contains multiple frequencies due to the distributed signals in the received beam, which in turn is due to distributed scattering by features throughout the depth of the retina. At step 16 a processor locates the strongest signal within the frequency spectrum. As explained above, the strongest frequency arises because of interferometry between the signal reflected from the NFL and the signal reflected from the layers between the IS/OS and the RPE. Once this frequency is determined, then at step 18 the distance between the NFL and the layers between the IS/OS and the RPE can be determined, and the thickness of the retina deduced.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao, Uchiyama, Kang and Wei with the teachings of Hathaway (i.e., to configure the photoanalyzer of combined Diao, Uchiyama, Kang and Wei to determine frequency of the return laser light in the manner of Hathaway) in order to facilitate determination of retinal thickness (Hathaway at Para. [0014]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”) previously cited US 2012/0283804 A1 to Kang et al. (“Kang”) and previously cited US6004314A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”) as applied to Claim 16 above, and further in view of US 2012/0157828 A1 to Hucalak et al. (“Hucalak”).
Regarding Claim 18, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
The combination of Diao, Uchiyama, Kang and Wei does not disclose:
further comprising a light source optically coupled to the multi-spot laser probe, wherein the light source comprises a broadband illumination source, a hyperspectral illumination source, or a multispectral illumination source
Hucalak describes “Optical coherence tomography and illumination using common light source” (Title). Hucalak is analogous art.
Hucalak teaches:
further comprising a light source optically coupled to the multi-spot laser probe, wherein the light source comprises a broadband illumination source, a hyperspectral illumination source, or a multispectral illumination source (Abstract, “A light source for a surgical system includes a broadband light source operable to produce broadband light. The light source further includes a wavelength splitter adapted to split the broadband light into illumination light having a spectral range covering at least a majority of the visible spectrum and surgical light having a spectral range outside of the spectral range of the illumination light. The light source then includes at least one surgical module adapted to control application of the surgical light.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao, Uchiyama, Kang and Wei with the teachings of Hucalak (i.e., to include such a broadband light source as taught by Hucalak connected in the prescribed manner) in order to reduce the number of parts required for operation by employing a common light source useful for multiple functions that provides effective illumination in small-scale probes (Hucalak at Para. [0007]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”) previously cited US 2012/0283804 A1 to Kang et al. (“Kang”) and previously cited US6004314A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”) as applied to Claim 16 above, and further in view of Non-Patent Literature Harper DJ, Konegger T, Augustin M, Schützenberger K, Eugui P, Lichtenegger A, Merkle CW, Hitzenberger CK, Glösmann M, Baumann B. Hyperspectral optical coherence tomography for in vivo visualization of melanin in the retinal pigment epithelium. J Biophotonics. 2019 Dec. 12 (“Harper”).
Regarding Claim 20, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
The combination of Diao, Uchiyama, Kang and Wei does not disclose:
wherein the photoanalyzer is further configured to determine hyperspectral or multispectral graphs that indicate which wavelengths of light are being absorbed and which wavelengths are being scattered to detect spectral signatures associated with certain ophthalmic disease conditions
Harper describes “Hyperspectral optical coherence tomography for in vivo visualization of melanin in the retinal pigment epithelium” (Title). Harper is thus analogous art.
Harper teaches:
wherein the photoanalyzer is further configured to determine hyperspectral or multispectral graphs that indicate which wavelengths of light are being absorbed and which wavelengths are being scattered to detect spectral signatures associated with certain ophthalmic disease conditions (Pg. 6, Fig. 4; Pg. 8, Fig. 6; Pg. 9, Fig. 7; and Pg. 10, Fig. 8 depict such a hyperspectral graph; Pg. 12, Right Column, Second Paragraph, “In order to develop a greater understanding of the complex relationship between the melanin in the RPE and visual function, a detailed optical analysis consisting of absorption, backscattering and polarization analysis is required, and this study is a step towards that goal.”);
Harper’s “information” can be used to “detect spectral signatures associated with certain ophthalmic diseases,” for example such ophthalmic diseases associated with melanin in the retinal pigment epithelium. (See, e.g., Pg. 2, Left Column, First Paragraph, “Owing to the close functional relationship of the RPE to the photoreceptors, it has been suggested that a change in RPE melanin content may be associated with diseases such as age‐related macular degeneration.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Uchiyama with the teachings of Harper (i.e., to configure Uchiyama’s photoanalyzer to determine information comprising hyperspectral graphs) “[i]n order to develop a greater understanding of the complex relationship between the melanin in the RPE and visual function” (Harper at Pg. 12, Right Column, Second Paragraph), which “may be associated with diseases such as age-related macular degeneration” (Harper at Pg. 2, Left Column, First Paragraph).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”) previously cited US 2012/0283804 A1 to Kang et al. (“Kang”) and previously cited US6004314A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”) as applied to Claim 16 above, and further in view of previously cited US 10,307,290 B2 to Kern et al. (“Kern”).
Regarding Claim 24, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
The combination of Diao, Uchiyama, Kang and Wei does not disclose:
wherein the probe comprises a vitreous cutter.
Kern describes “An illuminated microsurgical instrument is provided herein that includes a microsurgical instrument having a tubular member arranged to treat patient tissue at a surgical site, the tubular member having a distal tip, an inner surface, and an outer surface. … The illuminated microsurgical instrument further includes an optical fiber arranged to deliver light to the surgical site. The optical fiber includes a proximal end arranged to receive a light beam from a light source and also includes a curved distal end arranged to emit light adjacent to the distal tip,” (Abstract). Kern is thus analogous art.
Kern discloses:
wherein the probe comprises a vitreous cutter (Col. 2, Ln. 2-9, “An exemplary surgical system may include a light source coupleable to an optical fiber to provide illumination at a distal end of the optical fiber and may further include a vitrectomy subsystem having a vitrectomy cutter. The vitrectomy cutter may include a tubular member with a distal tip and a lumen extending therein. The lumen may be defined by an inner surface of a wall of the tubular member. The distal tip may include a port extending through the wall of the tubular member. The optical fiber may be arranged to deliver light to a surgical site.”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao, Uchiyama, Kang and Wei with the teachings of Kern (i.e., to include a vitreous cutter such as that of Kern in the probe of combined Diao, Uchiyama, Kang and Wei) in order to reduce the size of an incision through which the probe is inserted (Kern at Col. 1, Ln. 45-50).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”) previously cited US 2012/0283804 A1 to Kang et al. (“Kang”) and previously cited US6004314A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”) as applied to Claim 16 above, and further in view of previously cited US 2017/0252213 A1 to Furuuchi et al. (“Furuuchi”).
Regarding Claim 27, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
Uchiyama additionally discloses:
wherein the light source is a laser source (Para. [0361], “Also, using a laser light source with a long coherence light instead of the low- coherence light source 1 can yield capabilities the same as those of an interference microscope.”).
The combination of Diao, Uchiyama, Kang and Wei does not disclose:
further comprising a memory storing executable instructions that cause the system to: perform laser treatment on the body structure; and adjust at least one of a power, pulse duration, pulse frequency, or treatment time of the laser treatment based on the one or more spectral parameters of the body structure
Furuuchi describes “An ophthalmic laser treatment device … [which] includes an irradiation unit and a control unit…. [T]he irradiation unit includes a laser treatment light source (for example, a laser light source 401) and a scanning unit (for example, a scanning unit 408) which scans the patient's eye with the laser light emitted from the light source.” Furuuchi is thus analogous art.
Furuuchi discloses:
further comprising a memory storing executable instructions that cause the system to: (Para. [0065], “The control unit 70 is connected to each unit of the laser treatment device 1 so as to control the overall device. For example, the control unit 70 is generally realized by a central processing unit (CPU) 71, the ROM 72, and the RAM 73. The ROM 72 stores various programs for controlling an operation of the laser treatment device, an image processing program for processing the fundus image, and an initial value.”);
perform laser treatment on the body structure; (Para. [0099], “The control unit 70 irradiates the irradiation target on the fundus front image 99 with the laser light. In a case where a plurality of irradiation targets are present, the control unit 70 may sequentially irradiate the respective irradiation targets with the laser light.”);
and adjust at least one of a power, pulse duration, pulse frequency, or treatment time of the laser treatment (Fig. 2, “S5 Emit Laser;” “S6 Acquire Motion Contrast;” “End;” Para. [0105], “For example, the control unit 70 may detect a change in the motion contrasts obtained before and after the laser light irradiation. For example, the motion contrast acquired in Step Si and the motion contrast acquired in Step S2 are compared with each other;” Para. [0123], “The control unit 70 may automatically perform the laser light irradiation, based on the vascular density information.”);
Furuuchi’s “End” (i.e., ending the process, which process involves irradiating a target which changes dynamically throughout irradiation) is such an adjustment of treatment time as claimed when the term is afforded its broadest reasonable interpretation.
based on the one or more spectral parameters of the body structure (Para. [0119], “For example, the irradiation target of the laser light is set in advance by using the motion contrast acquired by the OCT device, and irradiation target information thereof is input to the laser treatment device. The laser treatment device may perform the laser light irradiation, based on the input irradiation target information.”);
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao, Uchiyama, Kang and Wei with the teachings of Furuuchi (i.e., to employ the device of combined Diao, Uchiyama, Kang and Wei in conjunction with such a laser treatment system as taught by Furuuchi) in order to ensure proper positioning of the laser treatment device during treatment (Furuuchi at Para. [0004])
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”) previously cited US 2012/0283804 A1 to Kang et al. (“Kang”) and previously cited US6004314A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”) as applied to Claim 16 above, and further in view of previously cited US 2015/0150460 A1 to Krishnaswamy et al. (“Krishnaswamy”).
Regarding Claim 28, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
The combination of Diao, Uchiyama, Kang and Wei does not disclose:
further comprising a memory storing executable instructions that cause the system to: determine a composition of fluid inside the body structure
Krishnaswamy describes “A tissue classifying system uses central illumination while detecting scattered light received from one or more rings surrounding the central illumination,” (Abstract). In Krishnaswamy’s system, “Received light couples to a spectrographic detection system that provides data to a processor with machine readable instructions for determining a classification of a type of tissue illuminated by the system,” (Abstract). Krishnaswamy is thus analogous art.
Krishnaswamy teaches:
further comprising a memory storing executable instructions that cause the system to: determine a composition of fluid inside the body structure(Para. [0050], “The corrected spectra are parameterized for hemoglobin concentration and degree of oxygenation by curve-fitting to known spectra of oxygenated HbO and deoxygenated Hb hemoglobin. The spectra are also parameterized for received brightness in the six hundred ten to seven hundred eighty five nanometer portion of the spectrum, which is a group of wavelengths where hemoglobin absorption is of less significance than at shorter wavelengths. The Hb and HbO parameters are used for correction of the scatter parameters.”).
Krishnaswamy’s use of “Hb and HbO parameters” is such “caus[ing] the system to: determine a composition of fluid inside the body structure” as claimed when the term is afforded its broadest reasonable interpretation.
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao, Uchiyama, Kang and Wei with the teachings of Krishnaswamy (i.e., to the device of combined Diao, Uchiyama, Kang and Wei such that it is capable of determining a composition of fluid inside the body structure) in order to facilitate classification of tissue types in tissue (Krishnaswamy at Para. [0084])
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”), previously cited US 2012/0283804 A1 to Kang et al. (“Kang”) and previously cited US6004314A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”) as applied to Claim 16 above, and further in view of previously cited US 2018/0172424 A1 to Comstock et al. (“Comstock”).
Regarding Claim 29, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
The combination of Diao, Uchiyama, Kang and Wei does not disclose
further comprising a Michelson interferometer.
Comstock describes “a self-aligning beam-shaping system for use in an optical coherence tomography probe” (Para. [0002]). Comstock is thus analogous art.
Comstock teaches:
further comprising a Michelson interferometer (Para. [0003], “The core of an OCT system generally is a Michelson interferometer….”).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao, Uchiyama, Kang and Wei with the teachings of Comstock (i.e., to use a Michelson interferometer) in order to facilitate “captur[ing] a high-resolution cross-sectional image of biological tissues” (Comstock at Para. [0003]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over previously cited US 2018/0243136 A1 to Diao et al. (“Diao”) in view of US 2004/0181148 A1 to Uchiyama et al. (“Uchiyama”), previously cited US 2012/0283804 A1 to Kang et al. (“Kang”) and previously cited US6004314A to Wei et al. (“Wei”) as evidenced by David Huang et al., "Optical Coherence Tomography," Science 254, 1178-1181 (1991) (“Huang”) as applied to Claim 16 above, and further in view of CN 104545788 B (“CN ‘788”).
Regarding Claim 30, the combination of Diao, Uchiyama, Kang and Wei renders obvious the entirety of Claim 16 as explained above.
Uchiyama additionally teaches:
further comprising: a fiber splitter optically coupled between the laser source and the optical circulator, (Fig. 59, “optical coupler 108”);
the fiber splitter comprising: an input configured to receive the laser light generated from the light source; (Para. [0245], “…near-infrared low-coherence light irradiated from a low- coherence light source 101 is guided to a first optical fiber 106, and is branched into a third optical fiber 109 and a fourth optical fiber 110 by an optical coupler 108 having four input/output.”);
a first output configured to transmit a first portion of the laser light from the input to the first port of the optical circulator; (Fig. 59, “third optical fiber 109”);
the second portion of the source light corresponds to a reference signal, and the second portion of the laser light is combined with the return light for transmission to the photoanalyzer. (Para. [0358], “Also, the optical path length of the optical path from the fourth optical fiber 110 through the frequency shifter 111, and through the optical fiber 289 to the optical coupler 290, is the reference side optical path length.”).
The combination of Diao, Uchiyama, Kang and Wei does not disclose:
and a second output configured to transmit a second portion of the laser light from the input to a fiber coupler, thereby bypassing the optical circulator,
CN ‘788 B describes “Real-time Positioning System Of The Eyeball Tumour Region A Based On The Eyeball Motion Characteristic” (Title) and “uses the real-time tracking OCT acquisition of the anterior segment image, then the image reconstruction and registration processing technology, accurately locating the tumor in the radiation area” (Abstract). CN ‘788 is analogous art.
CN ‘788 teaches:
and a second output configured to transmit a second portion of the laser light from the input to a fiber coupler, thereby bypassing the optical circulator, (CN ‘788 Machine Translation at Pg. 4, Bottom Paragraph through Pg. 5, First Paragraph).
It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of combined Diao, Uchiyama, Kang and Wei with the teachings of CN ‘788 (i.e., to include such a second output and associated fiber coupler configured in the manner taught by CN ‘788) in order to improve imaging accuracy (CN ‘788 Machine Translation at Pg. 3, Sixth Paragraph from Bottom of Page).
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 CHRISTOPHER J MUTCHLER whose telephone number is (571)272-8012. The examiner can normally be reached M-F 7:00 am - 4:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached on 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.J.M./Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
Prosecution Insights