DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim(s) 1-13 and 15-18 are rejected under 35 U.S.C. 102(a1).
Claim(s) 14 are rejected under 35 U.S.C. 103.
Response to Arguments
Applicant's arguments filed 04/28/2026 have been fully considered but they are moot in view of the new grounds of rejection presented below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-13 and 15-18 are rejected under 35 U.S.C. 102(a1) as being anticipated by US Publication 2023/0289956 to Kunio.
In regards to claims 1-13 and 15-18, Kunio discloses and shows in Figures 1-4, an optical measurement apparatus combining confocal measurement and low-coherence interferometric measurement (100), the apparatus and method comprising:
a system console and an imaging probe (160) (applicant’s housing) (Figure 1) (par. 9, 35, 40);
a confocal measurement subsystem (180, 183) disposed within the housing (par. 46-47);
an interferometric measurement subsystem (110, 120) disposed within the housing (par. 40-45);
a patient interface unit PIU (150) (applicant’s optical combiner) configured to provide the confocal measurement subsystem and the interferometric measurement subsystem with irradiative access to a region (170) to be measured located at a substantially static target location external to the housing (par. 42); and
a processing resource (200) operably coupled to the confocal measurement subsystem and the interferometric measurement subsystem (par. 45, 47, 49-50);
wherein the confocal measurement subsystem is configured to image longitudinally (321-1) in respect of a first subregion in the region to be measured in order to generate a longitudinal image of the first subregion (Figures 2a-b, 3) (par. 51-57, 65-67; wherein a real-time longitudinal fluorescence image is obtained);
the interferometric measurement subsystem is configured to image longitudinally (321-2) in respect of a second subregion in the region to be measured, the second subregion being axially spaced from the first subregion (par. 51-57, 65-67; wherein a real-time longitudinal OCT image is obtained); and
the processing resource is configured to calculate a first range in respect of the first subregion and a second range in respect of the second subregion (par. 51-57, 65-67; wherein a range of OCT data and a range of fluorescence data are obtained simultaneously); and
the processing resource is configured to calculate a confocal measurement and an interferometric measurement substantially contemporaneously over a measurement cycle (par. 51-57, 65-67; wherein confocal fluorescence data and OCT data are obtained simultaneously);
[claim 2] an optical path internal to the housing (107), the optical path extending from the optical combiner towards the region to be measured, the internal optical path being common to the confocal measurement subsystem and the interferometric measurement subsystem (Figure 1); and a length of the internal optical path is fixed (Figure 1) (par. 43; wherein the system is comprised of multiple optical fibers, each of which have a fixed length and are internal to the system console);
[claim 3] wherein the processing resource is configured to calculate, a confocal measurement and an interferometric measurement substantially contemporaneously over a measurement cycle (par. 51-57, 65-67, 71; wherein confocal fluorescence data and OCT data are obtained simultaneously);
[claim 4] wherein the interferometric measurement subsystem is substantially optically uninfluenced, by operation of the confocal measurement (par. 40-45, 71; wherein the OCT system obtains separate coherent measurements);
[claim 5] wherein the confocal measurement subsystem comprises at least one longitudinal imaging component (181, 189) (Figure 1) (par. 46-47; wherein the confocal subsystem includes a plurality of optical fibers);
the interferometric measurement subsystem comprises a measurement arm (10) and a reference arm (20) (par. 40-45); and
neither the measurement arm nor the reference arm of the interferometric measurement subsystem comprises the at least one longitudinal imaging component (Figure 1);
[claim 6] wherein the length of the internal optical path is unchanged over the measurement cycle (Figure 1) (par. 43; wherein the system is comprised of multiple optical fibers, each of which have a fixed length and are internal to the system console);
[claim 7] wherein the confocal measurement subsystem is operationally independent of the interferometric measurement subsystem (Figure 1) (par. 40-47, 71; wherein the OCT and fluorescence images are obtained by separate detectors and digital acquisition devices);
[claim 8] wherein the confocal measurement subsystem is operably coupled to the interferometric measurement subsystem (Figure 1) (par. 40-47, 71; wherein the OCT and fluorescence images are obtained through a common patient interface unit);
[claim 9] further comprising: projection optics (165-168) (par. 42) disposed opposite a first side of the optical combiner (Figure 2a); wherein the interferometric measurement subsystem comprises a measurement arm configured to collimate, light propagating therethrough, an end of the measurement arm being disposed opposite a second side of the optical combiner (Figure 2a) (par. 42, 51; wherein an optical fiber probe utilizes a distal optics assembly to project light onto a region of an object);
[claim 10] wherein: the interferometric measurement subsystem comprises: a reference arm (20) arrangement comprising a plurality of different selectable optical path lengths (Figure 1) (par. 40-41, 44); and scanning mirror and an optical delay line (140, 141) (applicant’s selection unit) configured to select an optical path length of the plurality of selectable optical path lengths (Figure 1) (par. 44; wherein the reference arm may utilize a scanning mirror and optical delay line to obtain a plurality of optical path lengths for time-domain OCT imaging);
[claim 11] wherein the confocal measurement subsystem comprises a first translatable optical element (151, 152) (par. 42-43) and the interferometric measurement subsystem comprises a second translatable optical element (140, 141) (par. 44), the first and second optical elements being configured to be translated substantially contemporaneously (par. 40- 44);
[claim 13] providing a calibration target (par. 60-62, 72-74; wherein a calibration dataset or LOD value is selected); and calculating an offset between a first test measurement made by the confocal measurement subsystem in respect of the calibration target and a second test measurement made by the interferometric measurement subsystem in respect of the calibration target (par. 72-74; wherein a fluorescence value is compared to a LOD threshold, and OCT data is compared to histological data or is compared to prior or post OCT frames of data);
[claim 15] wherein the optical measurement apparatus emits a substantially collimated beam of light in respect of the interferometric measurement subsystem (Figure 1-2b) (par. 42, 51; wherein an optical fiber probe utilizes a distal optics assembly to project light onto a region of an object);
[claims 17-18] wherein the confocal measurement subsystem comprises a fiber optic rotary joint (152) (applicant’s first translatable optical element) and the interferometric measurement subsystem comprises a pullback unit (151) (applicants’ a second translatable optical element); and the first and second translatable optical elements are carried by a patient interface unit (150) (applicant’s common translatable assembly) (Figure 1) (par. 42).
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.
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) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kunio, in view of US Patent 6,182,752 to Haruna et al.
In regards to claim 14, Kunio differs from the limitations in that it is silent to the apparatus and method further comprising:
[claim 14] determining an effective refractive index of the region to be measured; and using the effective refractive index to make the first and second measurements.
However, Haruna teaches and shows an interferometric system and method for measuring optical characteristics of an object, wherein the refractive index is measured and utilized to determine various other object characteristics (abstract; col. 1, ll. 8-68). Further, the measurement of a refractive index is disclosed as “one of the most basic” measurements in the optical field.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the invention, to modify Kunio to include the measurement of a refractive index for the advantage of obtaining one of the most basic measurements in optics and utilizing it to further characterize an object under test, with a reasonable expectation of success.
Conclusion
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JONATHAN M. HANSEN
Primary Examiner
Art Unit 2877
/JONATHAN M HANSEN/Primary Examiner, Art Unit 2877
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