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 .
Detailed Action
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6-10, & 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brennan et al (PGPub 2015/0150456) (Brennan) in view of Kang et al (PGPub 2013/0188196) (Kang) and further in view of Kemp et al (PGPub 2011/0077528) (Kemp).
Regarding Claims 1, & 8, Brennan discloses an OCT and probe (figs. 1 & 2), comprising:
a handheld light probe (200 & 220) comprising a first optical fiber and a second optical fiber, and configured to be inserted into an eye (Paragraph 87);
an illumination light source (Figs. 2A & 2B, White light illumination) configured to transmit an illumination beam for intraocular illumination via the first optical fiber (230-3) of the handheld light probe (Paragraph 52, endoillumination) ;
an optical coherence tomography (OCT) light source (Figs. 2A & 2B, OCT Laser Light source) configured to transmit an OCT beam towards an intraocular region of interest (ROI) via the second optical fiber (230-1) of the handheld light probe (Paragraph 52);
an OCT detector (fig. 1, 140) configured to detect light reflected by the intraocular ROI via the second optical fiber of the handheld light probe (Paragraph 50); and
a processor (150) configured to:
control the illumination light source to transmit the illumination beam, and control the OCT light source to transmit the OCT beam (Paragraph 52);
obtain an OCT signal based on the light detected by the OCT detector (Paragraph 51);
obtain a B-mode OCT image of the intraocular ROI with the handheld light probe across the intraocular ROI (Paragraph 90); and
control a display to display the B-mode OCT image (Paragraph 60);
Brennan does not explicitly disclose obtaining a B-mode OCT image of the intraocular ROI through freehand sweeping; and wherein the handheld light probe is configured as a common-path OCT probe, such that the transmitted OCT beam and the light reflected by the intraocular ROI share a common optical path with the second optical fiber, and wherein the system does not include a separate reference art for the OCT signal; and an optical filter configured to block light from the illumination light source, wherein the OCT light source is configured to transmit the OCT beam through the optical filter;
However, Kang teaches obtaining a B-mode OCT image of the intraocular ROI through freehand sweeping (Paragraph 87); and
wherein the handheld light probe is configured as a common-path OCT probe, such that the transmitted OCT beam and the light reflected by the intraocular ROI share a common optical path with the second optical fiber, and wherein the system does not include a separate reference art for the OCT signal (Paragraph 72);
Therefore, it would be obvious to one of ordinary skill at the time the invention was filed to modify Brennan with obtaining a B-mode OCT image of the intraocular ROI through freehand sweeping; wherein the handheld light probe is configured as a common-path OCT probe, such that the transmitted OCT beam and the light reflected by the intraocular ROI share a common optical path with the second optical fiber, and wherein the system does not include a separate reference art for the OCT signal because it is functionally equivalent to other methods of acquiring a B-scan with the advantage of letting a user directly control the area being imaged on the fly. Further, common path OCT is functionally equivalent to having a separate reference arm with the advantages of having less noise caused by environmental conditions varying between the two paths;
Brennan as modified by Kang still fails to explicitly disclose an optical filter configured to block light from the illumination light source, wherein the OCT light source is configured to transmit the OCT beam through the optical filter;
However, Kemp discloses a method and apparatus for simultaneous hemoglobin reflectivity measurement and OCT measurement (Fig. 1A) comprising optical filters (144) before the detector to block the light from the non-OCT source to the OCT detector (Paragraph 17);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Brennan as modified by Kang with an optical filter configured to block light from the illumination light source, wherein the OCT light source is configured to transmit the OCT beam through the optical filter because in a common path system with multiple modalities of function and multiple sources using a filter to block out the unwanted light from the other modalities’ light sources to the OCT detector improves the signal-to-noise ratio of the detection of the OCT signal thus improving the OCT image acquired.
The method of Claim 8 is also rejected by this disclosure.
Regarding Claims 2 & 9, Brennan as modified by Kang and Kemp discloses the aforementioned. Further, Brennan discloses wherein the second optical fiber (Fig. 9, 910) is disposed in a center of the handheld light probe, and wherein the first optical fiber (920) is circumferentially disposed around the second optical fiber (Paragraph 72).
Regarding Claims 3 & 10, Brennan as modified by Kang and Kemp discloses the aforementioned. Further, Brennan discloses wherein the second optical fiber (230-1, Fig. 2B) is disposed to be offset from a center of the handheld light probe.
Regarding Claims 6 & 13, Brennan as modified by Kang and Kemp discloses the aforementioned but fails to explicitly disclose a diameter of the handheld light probe is less than 1 millimeter, 950 microns, 900 microns or less, 850 microns or less, or 800 microns or less;
However, it would be obvious to have a light probe of the claimed dimensions, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984);
Therefore, it would be obvious to one of ordinary skill at the time the invention was filed to modify Brennan as modified by Kang and Kemp with a diameter of the handheld light probe is less than 1 millimeter, 950 microns, 900 microns or less, 850 microns or less, or 800 microns or less because one would want a probe for being inserted into an eye to be as small as possible to reduce the size of the insertion hole and speed healing.
Regarding Claims 7 & 14, Brennan as modified by Kang and Kemp discloses the aforementioned but fails to explicitly disclose wherein the handheld light probe further comprises a spherical dome lens;
However, the examiner takes official notice that it would have been obvious to one of ordinary skill in the art at the time the invention was filed;
Therefore, it would be obvious to one of ordinary skill at the time the invention was filed to modify Brennan as modified by Kang and Kemp with the handheld light probe further comprises a spherical dome lens because such a lens would be chosen because it improves the efficiency of coupling light to and from a fiber.
Regarding Claim 15, Brennan discloses an OCT and probe (figs. 1, 2 & 9), comprising:
a first optical fiber (230-3) configured to optically connect to an illumination light source, and transmit an illumination beam from the illumination light source for intraocular illumination (Paragraph 52); and
a second optical fiber (230-1) configured to optically connect to an optical coherence tomography (OCT) light source, transmit an OCT beam from the OCT light source towards an intraocular region of interest (ROI), and transmit light reflected by the intraocular ROI towards an OCT detector (Fig. 1, 114, Paragraph 52);
Brennan does not explicitly disclose wherein the handheld light probe is configured as a common-path OCT probe, such that the transmitted OCT beam and the light reflected by the intraocular ROI share a common optical path with the second optical fiber, and wherein the system does not include a separate reference art for the OCT signal; and an optical filter wherein the optical filter is configured to block light from the illumination light source;
However, Kang teaches wherein the handheld light probe is configured as a common-path OCT probe, such that the transmitted OCT beam and the light reflected by the intraocular ROI share a common optical path with the second optical fiber, and wherein the system does not include a separate reference art for the OCT signal (Paragraph 72);
Therefore, it would be obvious to one of ordinary skill at the time the invention was filed to modify Brennan with wherein the handheld light probe is configured as a common-path OCT probe, such that the transmitted OCT beam and the light reflected by the intraocular ROI share a common optical path with the second optical fiber, and wherein the system does not include a separate reference art for the OCT signal because common path OCT is functionally equivalent to having a separate reference arm with the advantages of having less noise caused by environmental conditions varying between the two paths;
Brennan as modified by Kang still fails to explicitly disclose an optical filter wherein the optical filter is configured to block light from the illumination light source;
However, Kemp discloses a method and apparatus for simultaneous hemoglobin reflectivity measurement and OCT measurement (Fig. 1A) comprising optical filters (144) before the detector to block the light from the non-OCT source to the OCT detector (Paragraph 17);
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Brennan as modified by Kang with an optical filter wherein the optical filter is configured to block light from the illumination light source because in a common path system with multiple modalities of function and multiple sources using a filter to block out the unwanted light from the other modalities’ light sources to the OCT detector improves the signal-to-noise ratio of the detection of the OCT signal thus improving the OCT image acquired.
Regarding Claim 16, Brennan as modified by Kang and Kemp discloses the aforementioned. Further, Brennan discloses wherein the second optical fiber is disposed in a center of the handheld light probe (Fig. 9, 910), and wherein the first optical fiber (920) is circumferentially disposed around the second optical fiber (Paragraph 72).
Regarding Claim 17, Brennan as modified by Kang and Kemp discloses the aforementioned. Further, Brennan discloses wherein the second optical fiber (Fig. 2B, 230-1) is disposed to be offset from a center of the handheld light probe.
Regarding Claim 18, Brennan as modified by Kang and Kemp discloses the aforementioned but fails to explicitly disclose a diameter of the handheld light probe is less than 1 millimeter, 950 microns, 900 microns or less, 850 microns or less, or 800 microns or less;
However, it would have been obvious to have a light probe of the claimed dimensions, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984);
Therefore, it would be obvious to one of ordinary skill at the time the invention was filed to modify Brennan as modified by Kang and Kemp with a diameter of the handheld light probe is less than 1 millimeter, 950 microns, 900 microns or less, 850 microns or less, or 800 microns or less because one would want a probe for being inserted into an eye to be as small as possible to reduce the size of the insertion hole and speed healing.
Regarding Claim 19, Brennan as modified by Kang and Kemp discloses the aforementioned but fails to explicitly a diameter of the second optical fiber is less than about 150 microns, about 125 microns or less, or about 100 microns or less;
However, it would have been obvious to have second optical fiber of less than about 150 microns, about 125 microns or less, or about 100 microns or less, since it has been held by the courts that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984);
Therefore, it would be obvious to one of ordinary skill at the time the invention was filed to modify Brennan as modified by Kang and Kemp with a diameter of the second optical fiber is less than about 150 microns, about 125 microns or less, or about 100 microns or less because one would want a probe, and thus also the fibers in the probe, for being inserted into an eye to be as small as possible to reduce the size of the insertion hole and speed healing.
Regarding Claim 20, Brennan as modified by Kang and Kemp discloses the aforementioned but fails to explicitly disclose a microlens disposed on the second optical fiber;
However, the examiner takes official notice that it would have been obvious to one of ordinary skill in the art at the time the invention was filed;
Therefore, it would be obvious to one of ordinary skill at the time the invention was filed to modify Brennan as modified by Kang and Kemp with a microlens disposed on the second optical fiber because a microlens is any one of a number of typical lenses that facilitate the coupling of light too and from a fiber when performing optical measurements and would be chosen based upon availability of parts and cost.
Claim(s) 4, 5, 11, & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brennan in view of Kang and Kemp and further in view of Borkovkina et al (Borkovkina S, Camino A, Janpongsri W, Sarunic MV, Jian Y. Real-time retinal layer segmentation of OCT volumes with GPU accelerated inferencing using a compressed, low-latency neural network. Biomed Opt Express. 2020 Jun 24;11(7):3968-3984. doi: 10.1364/BOE.395279. PMID: 33014579; PMCID: PMC7510892) (Borkovkina)
Regarding Claims 4 & 11, Brennan as modified by Kang and Kemp discloses the aforementioned but fails to explicitly disclose wherein the processor is further configured to: input the B-mode OCT image into a neural network; obtain a segmented B-mode OCT image based on an output of the neural network; and control the display to display the segmented B-mode OCT image;
However, Borkovkina teaches disclose wherein the processor is further configured to: input the B-mode OCT image into a neural network; obtain a segmented B-mode OCT image based on an output of the neural network; and control the display to display the segmented B-mode OCT image (Abstract);
Therefore, it would be obvious to one of ordinary skill at the time the invention was filed to modify Brennan as modified by Kang and Kemp with wherein the processor is further configured to: input the B-mode OCT image into a neural network; obtain a segmented B-mode OCT image based on an output of the neural network; and control the display to display the segmented B-mode OCT image because using a neural network to segment the OCT image allows for fast imaging which can provide real-time feedback during image-guided surgeries.
Regarding Claims 5 & 12, Brennan as modified by Kang and Kemp discloses the aforementioned. Further, Brennan discloses wherein the first optical fiber is a multi-mode optical fiber, and the second optical fiber is a single- mode optical fiber (Paragraph 72).
Conclusion
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/JONATHON COOK/Examiner, Art Unit 2877 March 19, 2026
/Kara E. Geisel/Supervisory Patent Examiner, Art Unit 2877