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 .
This Office Action is in response to the amendments dated December 22, 2025.
Claims 1-7 are pending.
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 present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1, 3, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Ikuta (US PGPUB 2020/0154985 – “Ikuta”) in view of Cabiri et al. (US PGPUB 2010/0272318 – “Cabiri”) and Hatori (US Patent 4,805,596 – “Hatori”).
Regarding Claim 1, Ikuta discloses:
An optical probe system, comprising:
a light source (Ikuta FIG. 1A, light source 110) that emits a first light (Ikuta paragraph [0019], “light source 110 (LS1) which is a broadband light source”);
a light probe (Ikuta FIG. 1A, probe 120) with a first light guide (Ikuta FIG. 1A, illumination fiber 130) including a light-emitting surface (Ikuta FIG. distal surface of probe distal optics 150 that emit light 202) and a second light guide (Ikuta FIG. 1A, detection fiber 210) including a light-receiving surface (Ikuta FIG. 1A, window cover 162 adjacent to detection fiber 210), wherein the first light guide transmits the first light and is configured to irradiate the first light (Ikuta FIG. 1A, light 202) on a measurement object (Ikuta FIG. 1A, sample 200) from the light-emitting surface, and the second light guide is configured to receive a return light from the measurement object through the light-receiving surface and to transmit the received return light as a second light (Ikuta paragraph [0035], “light is reflected, scattered, photoluminescence emitted by the sample 200. This light is collected by one or plural detection fibers 210”);
a sensor (Ikuta FIG. 1A, spectrometer 220) for measuring a brightness of the second light (Ikuta paragraph [0042], “At the spectrometer 220, the wavelength and intensity of each collected color light can be separately read out”).
Ikuta does not explicitly disclose an analyzer configured to calculate a size of the measurement object based on a measurement result of the sensor.
Cabiri teaches an analyzer (Cabiri FIG. 1, optical system 20; Cabiri paragraph [0305], “Optical system 20 further comprises a control unit (not shown), which is configured to carry out the image processing and analysis techniques described hereinbelow”) configured to calculate a size of the measurement object based on a measurement result of the sensor (Cabiri paragraph [0343], “the control unit estimates the size of a protrusion, such as a mid- or large-size polyp, by: (i) estimating a distance of the protrusion from the optical system, by measuring the brightness of at least (a) a first point on the protrusion relative to the brightness of (b) a second point on the protrusion or on an area of the wall of the GI tract in a vicinity of an edge of the protrusion; (ii) using the estimated distance to calculate a magnification of the protrusion; and (iii) deriving the size based on the magnification”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Cabiri’s control unit with the optical probe system disclosed by Ikuta. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an optical probe system that can identify a size of a protrusion/polyp, in order to assist the physician in creating an appropriate treatment protocol.
Examiner believes that Ikuta can be reasonably interpreted as disclosing wherein the light-emitting surface of the first light guide (Ikuta FIG. distal surface of probe distal optics 150 that emit light 202), and the light-receiving surface of the second light guide (Ikuta FIG. 1A, window cover 162 adjacent to detection fiber 210) are arranged on a same plane, even if that same plane is diagonal to a radial plane defined by probe 120.
However, for purposes of compact prosecution, Hatori is also cited for teaching wherein the light-emitting surface (Hatori FIG. 5, light guide fiber caps 18 and 30) of the first light guide (Hatori FIG. 5, light guide fiber bundle 24) and the light-receiving surface (Hatori FIG. 5, objective lens 26) of the second light guide (Hatori FIG. 5, image guide fiber bundle 22) are arranged on a same plane.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Hatori ’s coplanar light/image surfaces with the optical probe system taught by Ikuta in view of Cabiri. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an optical probe system having an illumination source and an image detector at a same distance from a target, in order to minimize any time/frequency shift and/or doppler effect in the imaging system.
Regarding Claim 3, Ikuta in view of Cabiri and Hatori teach the features of Claim 1, as described above.
Ikuta further discloses:
wherein the first light guide and the second light guide are a single light guide (Ikuta FIG. showing illumination fiber 130 and detection fibers 210 contained within a same outer sheath 180); and
wherein the first light is excited light and the second light is fluorescent light excited by the measured object (Ikuta paragraph [0035], “After illumination of the spectrally diffracted light 202 (e.g., red, green, and blue light) on the sample 200 (e.g., a tissue or in-vivo sample), light is reflected, scattered, photoluminescence emitted by the sample 200”).
Cabiri further teaches:
wherein the sensor measures the luminance of the fluorescent light, and
wherein the analyzer is configured to calculate the size of the measured object based on the luminance of the fluorescent light.
As described above, Cabiri teaches an analyzer (Cabiri FIG. 1, optical system 20; Cabiri paragraph [0305], “Optical system 20 further comprises a control unit (not shown), which is configured to carry out the image processing and analysis techniques described hereinbelow”) configured to calculate a size of the measurement object based on a measurement result of the sensor (Cabiri paragraph [0343], “the control unit estimates the size of a protrusion, such as a mid- or large-size polyp, by: (i) estimating a distance of the protrusion from the optical system, by measuring the brightness of at least (a) a first point on the protrusion relative to the brightness of (b) a second point on the protrusion or on an area of the wall of the GI tract in a vicinity of an edge of the protrusion; (ii) using the estimated distance to calculate a magnification of the protrusion; and (iii) deriving the size based on the magnification”).
Thus, Cabiri teaches wherein the sensor measures the returned light, and the analyzer is configured to calculate the size of the measured object based on the returned light.
Regarding Claim 7, Ikuta in view of Cabiri and Hatori teaches the features of Claim 1, as described above.
Hatori further teaches:
an endoscope (Hatori FIG. 4, endoscope 1) including an insertion portion (Hatori FIG. 4, insertion section 2),
wherein the same plane is a distal end surface of the insertion portion (Hatori FIG. 5, showing light guide fiber caps 18 and 30 and objective lens 26 arranged on a same plane at a distal end surface of insertion section 2).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Ikuta (US PGPUB 2020/0154985 – “Ikuta”) in view of Cabiri et al. (US PGPUB 2010/0272318 – “Cabiri”), Hatori (US Patent 4,805,596 – “Hatori”), and Davidson et al. (US PGPUB 2004/0127785 – “Davidson”).
Regarding Claim 2, Ikuta in view of Cabiri and Hatori teaches the features of Claim 1, as described above.
Ikuta further discloses:
an endoscope (Ikuta FIG. 1A, probe system 100), including an imaging unit (Ikuta FIG. 1A, microcontroller 230; Ikuta paragraph [0040], “After the spectrometer 220 and one or more detectors detect the light collected by fiber 210, an image processor 230 generates three 2D images, one for red, green, and blue, from the data.”) ,
wherein the first light guide and the second light guide are separately placed within an insertion portion of the endoscope (Ikuta FIG. 1A, showing separately placed illumination fiber 130 and detection fibers 210).
Cabiri further teaches wherein the light source is a laser and the first light is a laser beam of a predetermined luminance (Cabiri paragraph [0353], “the size of a target viewed through the fixed focal length optical system is calculated by projecting at least one low-divergence light beam, such as a laser beam, onto the target or the GI wall in a vicinity of the target. Because the actual size of the spot produced by the beam on the target or GI wall is known and constant, the spot size as detected by the image sensor indicates the distance to the target or GI wall.”).
Ikuta in view of Cabiri and Hatori does not explicitly teach:
wherein the analyzer is configured to calculate a distance between a distal end surface of the insertion portion to a stone from a ratio between the predetermined luminance and a luminance of the second light, and
wherein the analyzer is configured to calculate a size of the measurement object based on the calculated distance, a viewing angle of the imaging unit, a size of an endoscopic image acquired by the imaging unit, and a ratio between the size of the measurement object in the endoscopic image and the size of the endoscopic image.
Davidson teaches:
wherein the analyzer (Davidson FIG. 1A, processing circuit 41) is configured to calculate a distance between a distal end surface of the insertion portion to a stone from a ratio between the predetermined luminance and a luminance of the second light (Davidson paragraph [0027], “The known intensity of the illumination emanating from illumination device reflected by objects viewed correlates to their distance from the device. This intensity of reflected illumination may be measured by the data processor 14. Thus, for example, an object that reflects light only dimly is towards the far end of the illumination range, whereas an object that reflects light brightly is closer to the dome of the device.”; Examiner interprets a predetermined luminance as a constant for defining the ratio between the illumination and the reflection), and
wherein the analyzer is configured to calculate a size of the measurement object based on the calculated distance (Davidson paragraph [0028], “distance range may be used to calculate the estimated size of the object”), a viewing angle of the imaging unit (Davidson paragraph [0025], “a viewing angle of 120.degree. is assumed. Thus, based on simple trigonometric calculations, the effective viewing diameter of circular images displayed may be calculated”), a size of an endoscopic image acquired by the imaging unit and a ratio between the size of the measurement object in the endoscopic image and the size of the endoscopic image (Davidson FIG. 1B, scale 56; Davidson paragraph [0023], “a scale such as scale 56 (FIG. 1A, FIG. 1B) may be overlaid or otherwise added to on the displayed image to give an estimate of the sizes of objects”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Davidson’s processing circuit 41 with the optical probe system taught by Ikuta in view of Cabiri and Hatori. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an optical probe system that is able to determine the distance between a viewing sensor and an in situ target, in order to avoid collisions therebetween.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ikuta (US PGPUB 2020/0154985 – “Ikuta”) in view of Cabiri et al. (US PGPUB 2010/0272318 – “Cabiri”), Hatori (US Patent 4,805,596 – “Hatori”), and Benaron et al. (US Patent 5,785,658 – “Benaron”).
Regarding Claim 4, Ikuta in view of Cabiri and Hatori teaches the features of Claim 1, as described above.
Ikuta further discloses:
wherein the first light is illumination light including light having a plurality of wavelengths (Ikuta paragraph [0035], “After illumination of the spectrally diffracted light 202 (e.g., red, green, and blue light) on the sample 200”),
wherein the second light is reflected light of the illumination light reflected by the measurement object (Ikuta paragraph [0035], “light is reflected, scattered, photoluminescence emitted by the sample 200”),
wherein the sensor measures the brightness of the reflected light for each wavelength (Ikuta paragraph [0038], “the collected light is delivered to the spectrometer 220 via the detection fiber 210. The spectrometer 220 obtains one-dimensional (1D) spectral data for the 3 wavelength bands of light (e.g., blue, green, and red light).”).
Although Ikuta discloses utilizing a spectrometer to generate a two-dimensional image of an object (see Ikuta paragraph [0066], Ikuta in view of Cabiri and Hatori does not explicitly teach wherein the analyzer identifies a type of the measurement object based on the measurement results of the sensor.
Benaron teaches wherein the analyzer (Benaron FIG. 1, spectrometer 24) identifies a type of the measurement object based on the measurement results of the sensor (Benaron col. 11, lines 20-23, “process the spectral data determined by spectrometer 24 using one or more predetermined classification algorithms to determine the characteristic of the tissue being interrogated, and preferably to identify the tissue”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Benaron’s spectrographic analysis for identifying a type of tissue with the optical probe system taught by Ikuta in view of Cabiri and Hatori. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an optical probe system that is capable of specifically identifying tissue/polyps, in order to aid the physician in creating a treatment program for the patient.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ikuta (US PGPUB 2020/0154985 – “Ikuta”) in view of Cabiri et al. (US PGPUB 2010/0272318 – “Cabiri”), Hatori (US Patent 4,805,596 – “Hatori”), Benaron et al. (US Patent 5,785,658 – “Benaron”), and Chia et al. (US PGPUB 2015/0289937 – “Chia”).
Regarding Claim 5, Ikuta in view of Cabiri, Hatori, and Benaron teaches the features of Claim 4, as described above.
Ikuta in view of Cabiri, Hatori, and Benaron does not explicitly teach wherein the measurement object is a stone and the type of the measurement object identified by the analyzer is selected from the group consisting of a cholesterol-based stone, a mixed stone, and a dye stone.
Chia teaches wherein the measurement object is a stone and the type of the measurement object identified by the analyzer is selected from the group consisting of a cholesterol-based stone, a mixed stone, and a dye stone (Chia FIG. 1, stone analyzer 170 including Laser Induced Breakdown Spectrometer (LIBS) 184; Chia paragraph [0059], “stone analyzer 170 comprises a Laser Induced Breakdown Spectrometer (LIBS) 184 configured to perform laser induced breakdown spectroscopy on a targeted stone 120 through, for example, the secondary probe 118, and output a spectrometer reading indicative of a composition of the targeted stone 120; Chia paragraph [0003], “In the laser application, a holmium doped yttrium aluminium garnet (Ho:YAG) laser rod, or a thulium doped yttrium aluminium garnet (Tm:YAG) laser rod are used to produce laser energy having a wavelength of around 2000-2100 nm to break up stones of all types.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Chia’s laser lithotripsy with the optical probe system taught by Ikuta in view of Cabiri, Hatori, and Benaron. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a system that is capable of breaking up a wide range of stones, as described in Chia paragraph [0003].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ikuta (US PGPUB 2020/0154985 – “Ikuta”) in view of Cabiri et al. (US PGPUB 2010/0272318 – “Cabiri”), Hatori (US Patent 4,805,596 – “Hatori”), and Vayser et al. (US PGPUB 2013/0012783 – “Vayser”).
Regarding Claim 6, Ikuta in view of Cabiri and Hatori teaches the features of Claim 1, as described above.
Ikuta further discloses wherein the first light guide and the second light guide are a single light guide within an insertion portion of an endoscope (Ikuta FIG. showing illumination fiber 130 and detection fibers 210 contained within a same outer sheath 180);
wherein the insertion portion of the endoscope has a distal end surface (Ikuta FIG. 1A, distal end of probe 120)
wherein a tip of the single light guide is disposed on the distal end surface of the insertion portion (Ikuta FIG. 1A, showing illumination fiber 130 disposed on the distal end surface of probe 120).
Ikuta in view of Cabiri and Hatori does not explicitly teach:
an aspiration channel,
wherein the insertion portion of the endoscope has a protruding portion, an end surface of the protruding portion protruding more anteriorly than the distal end surface,
wherein an opening of the aspiration channel is disposed in the end surface of the protruding portion.
Vayser teaches:
an aspiration channel (Vayser FIG. 1, suction tube 12),
wherein the insertion portion of the endoscope has a protruding portion (Vayser FIG. 1, distal portion 12D), an end surface of the protruding portion protruding more anteriorly than the distal end surface (Vayser FIG. 1, showing distal end of distal portion 12D more anteriorly than the distal end surface for the suction apparatus 10 that contains the illumination waveguide 14),
wherein an opening of the aspiration channel is disposed in the end surface of the protruding portion (Vayser FIG. 1, showing opening of distal portion 12D of suction tube 12).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Vayser’s distally protruding suction tube with the optical probe system taught by Ikuta in view of Cabiri and Hatori. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an optical probe system that provide illumination for a suction channel/tube being utilized (see also Vayser FIG. 4A).
Response to Arguments
Applicant’s arguments, see pages 7-8, filed December 22, 2025, with respect to the objection to the Specification, have been fully considered and are persuasive in view of the amendment to the Abstract. The objection to the Specification has been withdrawn.
Applicant’s arguments, see page 8, filed December 22, 2025, with respect to the objections to the drawings, have been fully considered and are persuasive in view of the amendment to the claims. The objection to the drawings has been withdrawn.
Applicant’s arguments, see page 8, filed December 22, 2025, with respect to the rejection of Claim 3 under 35 U.S.C. 112(b), have been fully considered and are persuasive in view of the amendment to the claims. The rejection of Claim 3 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see pages 8-11, filed December 22, 2025, with respect to the rejection of Claims 1 and 3 under 35 U.S.C. 103, have been fully considered but are not persuasive. However, as described above, in the interest of compact prosecution the present Office Action further cites Hatori (US Patent 4,805,596 – “Hatori”) in the rejection of Claim 1, as described above.
On page 10, Applicant asserts that Cabiri et al. (US PGPUB 2010/0272318 – “Cabiri”) fails to teach an optical fiber, since it is not shown in the figures of Cabiri. However, Examiner interprets MPEP 2152.02(b) as stating that while critical features must be shown in the figures for a current patent application, this same requirement does not apply to prior art. Rather, the prior art provisions “require only that the claimed invention is "described" in a prior art document (patent, published patent application, or printed publication)”. Examiner believes that Cabiri adequately describes optical fibers in Cabiri paragraph [0317], which states “light source 100 comprises one or more LEDs (or other lights) located at a different site, but coupled to support structure 106 via optical fibers”.
On page 11, Applicant asserts that Claim 3 is also non-obvious since it depends on Claim 1. For reasons stated above, Examiner believes that Claim 1 is obvious.
Therefore, the rejection of Claims 1-7 under 35 U.S.C. 103 is maintained.
Finally, Examiner interprets the feature of a “single light guide”, found in the passage “wherein the first light guide and the second light guide are a single light guide” (as claimed in Claim 3 and Claim 6), is simply a combination of light fibers. If Applicant intends to interpret a “single light guide” as a single light fiber, Applicant is advised that doing so would likely create a rejection under 35 U.S.C. 112a/b as well as new objections to the figures. That is, while it is known that a single light fiber can transmit different wavelengths and/or in bi-directions, such fibers require additional elements in order to overcome wavelength interference, timing requirements, etc. For example, Kuhara et al. (US PGPUB 2004/0146304 – “Kuhara”) teaches in Kuhara FIG. 1 single-fiber bidirectional communication over a single fiber, but requires an optical transceiver module 10 to coordinate such light communication/transmission. Jin et al. (US PGPUB 2009/0202244 – “Jin”) also teaches in Jin FIG. 1 a bidirectional optical cable 107, but requires optical filters 101/102 to direct and manage different wavelengths of light. Culpepper (US Patent 8,588,613 – “Culpepper”) teaches in Culpepper FIG. 4 a single fiber optic cable simultaneously transmitting light at different wavelengths, but requires a MUX/DEMUX system (Culpepper FIG. 4, elements 412 and 422) to parse out the different wavelengths of light. Examiner is unable to identify any depiction or description of elements/structures that perform such features.
Conclusion
Other prior art made of record and not relied upon is considered pertinent to applicant's disclosure includes: Takaoka et al. (US PGPUB 2013/0329224 – “Takaoka”), which teaches in Takaoka FIG. 1 a single probe 3 that includes light detection fibers 7 and 8 along with an illumination fiber 5, such that the light detection fibers and the illumination fiber are a single light guide.
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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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, Anhtuan Nguyen can be reached at (571)272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/02/2026