DETAILED ACTION
Applicant’s arguments, filed on 10/02/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 10/02/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-4, 6-13, and 15-22 are the current claims hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, line 8, “the least one” should read “the at least one”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sheth (US 20160030022).
Regarding independent claim 1, Sheth teaches an endoscope apparatus for obtaining light signals for generating at least one image of a portion of an object using at least one imaging modality ([0007]: “The systems and method of the present disclosure overcome the above and other drawbacks by providing an optical biopsy needle and endoscope system”), wherein the apparatus comprises:
an ultrafine needle having a body with first and second ends ([0020]: “The hand-held system is introduced percutaneously to image tissue at the tip or leading edge of a biopsy introducer needle.”), the first end being adapted for insertion into the object ([0020]: “The hand-held system is introduced percutaneously to image tissue at the tip or leading edge of a biopsy introducer needle.”);
a fiber probe that has a dimension so that the fiber probe is slidably disposed in the ultrafine needle ([0026]: “At least one fiber-optic bundle (not shown) extends through the length of the biopsy needle”; Abstract: “The system includes an imaging tool configured to slide coaxially through the biopsy introducer needle toward a tip of the biopsy introducer needle”);
an optical cable having a body with first and second ends ([0026]: “one fiber-optic bundle can extend through the needle 32 for excitation light transmission, and another fiber-optic bundle can extend through the needle 32 for emitted light transmission.”), the body having an outer cladding that surrounds a plurality of illumination optical fibers ([0021]: “The system 10 can include an imaging endoscope 12 with an eyepiece 14, an illumination port 16, and an imaging catheter 18”, The imaging catheter surrounds the fiber-optic bundle.) and a plurality of collection optical fibers ([0026]: “one fiber-optic bundle can extend through the needle 32 for excitation light transmission, and another fiber-optic bundle can extend through the needle 32 for emitted light transmission.”), the first end of the optical cable forming the fiber probe (Figs. 3 and 4); and
a port having first and second ends ([0021]: “the system 10 can include … an illumination port 16”), the first end of the port being coupled to the second end of the optical cable and the second end of the port being connected to at least one light source (Fig. 1) and at least one sensor ([0021]: “The system 10 can include … a camera 22 coupled to the imaging endoscope 12”) where the at least one light source is adapted to provide at least one excitation light signal to the portion of the object to be imaged during use ([0024]: “The laser 20 can be coupled to the illumination port 16, e.g., through a fiber-optic cable, so that activating the laser 20 causes excitation light to be emitted through a tip of the imaging catheter 18.”) and the at least one sensor is adapted to receive reflected light signals from the portion of the object when it is illuminated during use for generating the at least one image ([0024]: “The camera 22 can be configured to capture images from the imaging catheter 18 and, thus, can capture the resulting fluorescence following excitation light emission by the laser 20.).
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.
Claims 2, 7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over by Sheth in further view of Demers (WO 2014145110).
Regarding independent claim 2, Sheth teaches an endoscope for obtaining light signals for generating multiple images of a portion of an object using several imaging modalities ([0007]: “The systems and method of the present disclosure overcome the above and other drawbacks by providing an optical biopsy needle and endoscope system”), wherein the endoscope comprises:
an ultrafine needle having a body with first and second ends ([0020]: “The hand-held system is introduced percutaneously to image tissue at the tip or leading edge of a biopsy introducer needle.”; [0026]: “a system 10 can include an integrated fiber-optic biopsy needle”), the first end being adapted for insertion into the object ([0020]: “The hand-held system is introduced percutaneously to image tissue at the tip or leading edge of a biopsy introducer needle.”);
a fiber probe that has a dimension so that the fiber probe is slidably disposed in the ultrafine needle ([0026]: “At least one fiber-optic bundle (not shown) extends through the length of the biopsy needle”; Abstract: “The system includes an imaging tool configured to slide coaxially through the biopsy introducer needle toward a tip of the biopsy introducer needle”), the fiber probe including a plurality of optical fibers or cores that act as illumination optical fibers and collection optical fibers ([0026]: “one fiber-optic bundle can extend through the needle 32 for excitation light transmission, and another fiber-optic bundle can extend through the needle 32 for emitted light transmission.”);
an optical assembly that is coupled to the fiber probe (Fig. 4, reference characters 22, 14, 40, and 20).
However, Sheth does not teach the optical assembly being coupled to the fiber probe via an objective.
Demers discloses a method and apparatus for a microendoscope. Specifically, Demers teaches an optical assembly that is coupled to the fiber probe via an objective ([0059]: “an embodiment of an endoscope probe 100 is shown having a distal end 102 and an objective lens 104 that is positioned at the distal end for imaging a field of view into a distal end of an imaging fiber bundle. The objective lens and imaging fiber bundle have a large enough cross-sectional area that they encompass a longitudinal center axis 106 of the probe. The endoscopic probe also includes two illumination fibers 108 and 110.”). Sheth and Demers are analogous arts as they are both related to endoscopes.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the objective from Demers into the apparatus from Sheth as it allows the device to gather a clear signal, ensuring the measurement is correct.
The Sheth/Demers combination teaches the optical assembly including:
at least one transmission optical pathway that is adapted to optically couple at least one of the optical fibers or cores with at least one light source via at least one set of optical elements (Sheth, Fig. 4, reference character 20) to provide at least one excitation light signal to the portion of the object to be imaged during use (Sheth,[0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”); and
at least one return optical pathway that is adapted to optically couple, via the at least one set of optical elements (Sheth, Fig. 4), at least one of the optical fibers or cores that receive reflected light signals from the portion of the object when it is illuminated during use with at least one sensor for generating at least one image (Sheth, Fig. 4; [0024]: “The camera 22 can be configured to capture images from the imaging catheter”).
Regarding claim 7, the Sheth/Demers combination teaches the apparatus of claim 2, wherein the optical fibers or cores are adapted to provide a resolution from 250 to 6,000 pixels (Sheth, [0024]: “, the camera 22 can be coupled to the eyepiece 14 and, in some configurations, can be a charge-coupled device (CCD) camera, configured to acquire high-temporal and high-spatial resolution images in real time”. It produces high spatial resolution images such that it is capable of providing a resolution from about 250-6000 pixels.).
Regarding claim 12, the Sheth/Demers combination teaches the apparatus of claim 2, wherein the apparatus includes a second channel that is adapted to be coupled to a suction device for collecting biopsy tissues and cells during use from the portion of the object being imaged ([0036]: “a biopsy sample maybe collected using the stylet or the fiber-optic biopsy needle 32, and the method 48 (or at least process blocks 56-64) may be repeated to obtain multiple biopsy samples.”).
Claims 3, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over the Sheth/Demers combination as applied to claim 2 above, and further in view of Day (US 20170049329).
Regarding claim 3, the Sheth/Demers combination teaches the endoscope of claim 2.
The Sheth/Demers combination does not disclose at least two of each aspect of the optical assembly, however a duplication of parts is recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(VI)(b). The motivation for doing so would be allowing the device to generate multiple images which would provide the user with more information about the object that is being evaluated.
Furthermore, Day discloses a probe used for observing and testing a tissue. Specifically, Day discloses using two probes together for analysis, which includes having at least two of each component of the optical assembly ([0057]: “two probes could be used together, with one providing the excitation radiation and the other transmitting the radiation from the sample to the receiver. This may enable the probes to be used for spatially offset Raman spectroscopy and/or transmission measurements.”). Sheth and Day are analogous arts as they both relate to probes used to observe and analyze tissues.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include using two probes from Day as it allows the device to generate multiple images which would provide the user with more information about the object that is being evaluated.
The Sheth/Demers/Day combination teaches wherein the optical assembly comprises:
at least two transmission optical pathways that are part of the at least one transmission optical pathway and are adapted to optically couple at least one of the optical fibers or cores with at least two light sources that are part of the at least one light source, via at least two sets of optical elements that are part of the at least one optical element, (Sheth, Fig. 4, reference character 20) to provide at least two excitation light signals that are part of the at least one excitation light signal, to the portion of the object to be imaged during use (Sheth, [0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”); and
at least two return optical pathways that are part of the at least one return optical pathway, are adapted to optically couple, via at least two second sets of optical elements (Sheth, Fig. 4), at least one of the optical fibers or cores, that receive reflected light signals from the portion of the object when it is illuminated during use, with at least two sensors for generating at least two images that are part of the at least one image (Sheth, Fig. 4; [0024]: “The camera 22 can be configured to capture images from the imaging catheter”),
wherein the at least two excitation light signals and the at least two sensors that are part of the at least one sensor, are adapted for generating two or more of a white light image and an Autofluorescence image (Sheth, [0042]: “the system 10 can be integrated into conventional endoscopic systems to enable simultaneously imaging fluorescence and white light in vivo.”).
However, the Sheth/Demers/Day combination does not teach generating a Raman image.
Day teaches generating a Raman image ([0053]: “The probe 10 according to embodiments of the invention enables subcutaneous tissue to be tested using spectroscopy, preferably Raman spectroscopy.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the Raman image from Day into the Sheth/Demers/Day combination as it allows the endoscope to produce another image type, which can provide more information to the user that may not have been able to be shown otherwise.
Regarding claim 9, the Sheth/Demers combination teaches the apparatus of claim 2, wherein the optical assembly comprises:
a second transmission optical pathway, that is part of the at least one transmission optical pathway and is adapted for sending a second excitation light signal, that is part of the at least one excitation signal, from a second light source that is part of the at least one light source (Sheth, Fig. 4, reference character 20; [0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”) and provides a 785 nm excitation light signal (Sheth, [0024]: “the laser 20 may be a near-infrared (NIR) laser (such as a 450 mW, 785 nm laser) to be used with optical imaging agents that fluoresce under that range.”) via a second set of optical elements that is part of the at least one set of optical elements, to the objective (Sheth, Fig. 4) for transmission to the portion of the object being imaged (Sheth, [0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”); and
a second return optical pathway that is part of the least one return optical pathway and is adapted for sending second reflected signals from the portion of the object being imaged in response to the second excitation light signal from the objective (Sheth, Fig. 4) to a light sensor for obtaining images for wavelengths at 785 nm (Sheth, Fig. 4; [0024]: “The laser 20 can emit a specific wavelength based on the optical imaging agent. For example, in one configuration, the laser 20 may be a near-infrared (NIR) laser (such as a 450 mW, 785 nm laser) to be used with optical imaging agents that fluoresce under that range. The camera 22 can be configured to capture images from the imaging catheter”).
However, the Sheth/Demers combination does not teach obtaining Raman images.
Day teaches obtaining Raman images ([0053]: “The probe 10 according to embodiments of the invention enables subcutaneous tissue to be tested using spectroscopy, preferably Raman spectroscopy.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the Raman image from Day into the endoscope from the Sheth/Demers combination as it allows the endoscope to produce another image type, which can provide more information to the user that may not have been able to be shown otherwise.
Regarding claim 11, the Sheth/Demers combination teaches the apparatus of claim 2.
However, the Sheth/Demers combination does not teach wherein the optical assembly further comprises a notch filter for eliminating cross-talk between different optical pathways during use.
Day teaches wherein the optical assembly further comprises a notch filter for eliminating cross-talk between optical pathways of the at least one transmission optical pathway and/or the at least one return optical pathway during use ([0089]: “The return path light is collimated by the lenses 76c and passes through a long wavelength pass filter or notch filter 76b that removes light at the laser wavelength.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the filter from Day into the endoscope from the Sheth/Demers combination as it allows the device to filter out unwanted information and only provide the correct signals to the user it be imaged, making sure the images are accurate and do not contain any unwanted information.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Sheth/Demers combination as applied to claim 2 above, and further in view of Pitris (WO 0042906).
Regarding claim 4, the Sheth/Demers combination teaches the apparatus of claim 2.
However, the Sheth/Demers combination is silent on the diameter of the ultrafine needle.
Pitris discloses a fiber optic needle probe. Specifically, Pitris teaches wherein the body of the ultrafine needle has an outer diameter of 200 microns and/or an inner diameter of 120 microns (Page 22, lines 5-7: “The minimum thickness for the needle 5 material will be approximately 20 to 50 microns. This results in a minimum total outer diameter of the needle 5 of 100 to 200 microns”). Sheth and Pitris are analogous arts as they are both related to devices that use fiber optic needles.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the diameter from Pitris into the Sheth/Demers combination as the combination is silent on the diameter, and Pitris discloses a suitable diameter in an analogous device.
Claims 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over the Sheth/Demers combination as applied to claim 2 above, and further in view of Gatto (US 20030055315).
Regarding claim 6, the Sheth/Demers combination teaches the apparatus of claim 2.
However, the Sheth/Demers combination is silent on the length of the ultrafine needle.
Gatto discloses an endoscope for evaluating breast cancer. Specifically, Gatto teaches wherein the length of the ultrafine needle is at least 3 to 4.5 cm or longer ([0044]: “Lumen tube 101 alternatively can be a semi-rigid tube made of semi-rigid plastic or some other suitable material having a length between 3 cm and 30 cm.”). Sheth and Gatto are analogous arts as they both relate to probes used to observe and analyze tissues.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the length from Gatto in the endoscope from the Sheth/Demers combination, as the Sheth/Demers combination is silent on the length and Gatto provides a suitable length in an analogous device.
Regarding claim 13, the Sheth/Demers combination teaches the apparatus of claim 2.
However, the Sheth/Demers combination does not teach the apparatus including a third channel that is adapted to be coupled to a rinsing device to provide a rinsing solution during use to the portion of the object being imaged.
Gatto teaches wherein the apparatus includes a third channel that is adapted to be coupled to a rinsing device to provide a rinsing solution during use to the portion of the object being imaged ([0074]: “An irrigation channel 605 is also needed to provide saline and other medication or fluids to the distal end 111”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the third channel that is coupled to a rinsing device from Gatto into the endoscope from the Sheth/Demers combination, as it allows for the area being imaged to be rinsed before imaging, which will create a clearer image and provide a more comprehensive view of the area.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over the Sheth/Demers combination as applied to claim 2 above, and further in view of Hendriks (US 20100317964) and Day.
Regarding claim 8, the Sheth/Demers combination teaches the apparatus of claim 2, wherein the optical assembly comprises:
a first transmission optical pathway that is part of the at least one transmission optical pathway and is adapted for sending an excitation light signal from a first light source that is part of the at least one light source (Sheth, Fig. 4, reference character 20; [0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”) via a first set of optical elements, that is part of the at least one set of optical elements, to the objective (Sheth, Fig. 4) for transmission to the portion of the object being imaged (Sheth, [0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”).
However, the Sheth/Demers combination does not teach the excitation light signal being a broadband excitation light signal and the light source being a broadband light source.
Hendriks discloses a system for inserting and using a biopsy device to examine and analyze a tissue. Specifically, Hendriks teaches the excitation light signal being a broadband excitation light signal and the light source being a broadband light source ([0047]: “The light source coupled to the fiber is a broadband light source.”). Sheth and Hendriks are analogous arts as they both relate to probes used to observe and analyze tissues.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the broadband excitation light signal from Hendriks into the endoscope from the Sheth/Demers combination as the Sheth/Demers combination does not state the type of excitation light signal being used and Hendriks provides the broadband excitation light signal in an analogous art that allows for highly detailed imaging of the tissues being examined.
The Sheth/Demers/Hendriks combination teaches a first return optical pathway that is part of the at least one return optical pathway and is adapted for sending first reflected signals from the portion of the object being imaged in response to the broadband excitation light signal from the objective (Sheth, Fig. 4; [0024]: “The camera 22 can be configured to capture images from the imaging catheter”) to a camera sensor for white light color imaging (Sheth, [0042]: “the system 10 can be integrated into conventional endoscopic systems to enable simultaneously imaging fluorescence and white light in vivo.”).
However, the Sheth/Demers/Hendriks combination does not teach a spectral imaging sensor for spectral imaging.
Day teaches a spectral imaging sensor for spectral imaging ([0089]: “The collection fibres 78 return the light to the spectrometer for spectral analysis.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the spectral from Day into the endoscope from the Sheth/Demers/Hendriks combination as it allows the endoscope to produce another image type, which can provide more information to the user that may not have been able to be shown otherwise.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the Sheth/Demers combination as applied to claim 2 above, and further in view of Kaneko (US 20150119722).
Regarding claim 10, the Sheth/Demers combination teaches the apparatus of claim 2, wherein the optical assembly comprises:
a third transmission optical pathway that is part of the at least one transmission optical pathway, and is adapted for sending a third excitation light signal that is part of the at least one excitation light signal, from a third light source that is part of the at least one light source (Sheth, Fig. 4, reference character 20; [0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”) via a third set of optical elements, that is part of the at least one set of optical elements, to the objective (Sheth, Fig. 4) for transmission to the portion of the object being imaged (Sheth, [0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”); and
a third return optical pathway that is part of the at least one return optical pathway and is adapted for sending third reflected signals from the portion of the object being imaged in response to the third excitation light signal from the objective (Sheth, Fig. 4) to a third light sensor for obtaining Fluorescence images or Raman and Fluorescence images (Sheth, Fig. 4; [0024]: “The camera 22 can be configured to capture images from the imaging catheter”; [0042]: “the system 10 can be integrated into conventional endoscopic systems to enable simultaneously imaging fluorescence and white light in vivo.”).
However, the Sheth/Demers combination does not disclose the third light source providing a 532 excitation light signal.
Kaneko teaches an image processing apparatus that acquires images of tissues using excitation lights for analysis. Specifically, Kaneko teaches using a 532 nm excitation light signal to measure wavelengths less than 765 nm ([0069]: “FIG. 5 is a fluorescence observation image in a wavelength band of the excitation light of 530 nm to 560 nm, and imaging wavelengths of 570 nm to 700 nm.”). Sheth and Kaneko are analogous arts as they both use excitation light signals to view and analyze tissues.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use the excitation light signal for analysis from Kaneko in the endoscope from the Sheth/Demers combination, as the Sheth/Demers combination is silent on the specific wavelengths analyzed, and Kaneko provides suitable wavelengths in an analogous device.
Claims 15, 19, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over the Sheth/Demers/Day combination as applied to claim 3 above, and further in view of Hendriks.
Regarding claim 15, the Sheth/Demers/Day combination teaches a method for generating at least one image of a portion of an object using an endoscope apparatus as defined in claim 3 (Sheth, Abstract: “An interventional optical molecular imaging system and method are provided for use with a biopsy introducer needle.”), wherein the method comprises:
inserting the ultrafine needle into the object (Sheth, [0020]: “The hand-held system is introduced percutaneously to image tissue at the tip or leading edge of a biopsy introducer needle.”)
coupling a light source to the fiber probe (Sheth, Fig. 4).
However, the Sheth/Demers/Day combination does not teach the light source being a broadband light source.
Hendriks teaches the light source being a broadband light source ([0047]: “The light source coupled to the fiber is a broadband light source.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the broadband excitation light signal from Hendriks into the endoscope from the Sheth/Demers/Day combination as the Sheth/Demers/Day combination does not state the type of excitation light signal being used and Hendriks provides the broadband excitation light signal in an analogous art that allows for highly detailed imaging of the tissues being examined.
The Sheth/Demers/Day/Hendriks combination teaches generating the at least one excitation light signal using the at least one light source or the at least two light sources (Hendricks, [0047]: “The light source coupled to the fiber is a broadband light source.”);
receiving the reflected light signals from the portion of the object (Sheth, [0026]: “A hub 36 of the biopsy needle 32 can be coupled to a liquid light guide 38 further connected to the laser 20 and the camera 22. A dichroic mirror 40 can direct emitted light from the light guide 38 to the camera 22 and excitation light from the laser 20 to the light guide 38 and toward the needle 32.”); and
transmitting the reflected light signals to the at least one sensor for generating a white light image, an autofluorescence image (Sheth, [0042]: “the system 10 can be integrated into conventional endoscopic systems to enable simultaneously imaging fluorescence and white light in vivo.”) and/or a Raman spectral image (Day, [0053]: “The probe 10 according to embodiments of the invention enables subcutaneous tissue to be tested using spectroscopy, preferably Raman spectroscopy.”), wherein the ultrafine needle contains the fiber probe (Sheth, [0026]: “At least one fiber-optic bundle (not shown) extends through the length of the biopsy needle”).
Regarding claim 19, the Sheth/Demers/Day/Hendriks combination teaches the method of claim 15, wherein the method comprises generating a thyroid image, a prostate image (Hendriks, [0002]: “An example of a needle biopsy is shown in FIG. 1, where a biopsy is taken from the prostate via the rectum.”), a breast or an ascites image.
Regarding claim 21, the Sheth/Demers/Day/Hendriks combination teaches the method of claim 15, wherein the method further comprises coupling the endoscope apparatus to a suction device and obtaining a biopsy sample from the object (Sheth, [0036]: “a biopsy sample maybe collected using the stylet or the fiber-optic biopsy needle 32, and the method 48 (or at least process blocks 56-64) may be repeated to obtain multiple biopsy samples.”).
Regarding claim 22, the Sheth/Demers/Day/Hendriks combination teaches the method of claim 21, wherein the method further comprises obtaining a thyroid biopsy, a prostate biopsy (Hendriks, [0002]: “An example of a needle biopsy is shown in FIG. 1, where a biopsy is taken from the prostate via the rectum.”), or an ascites biopsy.
Claims 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over the Sheth/Demers/Day/Hendriks combination as applied to claim 15 above, and further in view of Gatto.
Regarding claim 16, the Sheth/Demers/Day/Hendriks combination teaches the method of claim 15.
However, the Sheth/Demers/Day/Hendriks combination does not teach wherein inserting the ultrafine needle into the object comprises: inserting a wire into the ultrafine needle; inserting the wire and the ultrafine needle into the object; removing the wire from the ultrafine needle; and inserting the fiber probe into the needle.
Gatto teaches wherein inserting the ultrafine needle into the object comprises: inserting a wire into the ultrafine needle; inserting the wire and the ultrafine needle into the object; removing the wire from the ultrafine needle; and inserting the fiber probe into the needle ([0006]: “a physician can use a guidewire to assist the cannula or catheter in order to find the desired location in the body tissue. Once the catheter is positioned properly, the guidewire may be withdrawn from the catheter and thereafter an endoscope inserted through a lumen of the catheter.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the wire from Gatto into the Sheth/Demers/Day/Hendriks combination as it allows the device to have a guide to placing the needle into the correct location, ensuring it gets to the proper spot and is easier to place.
Regarding claim 17, the Sheth/Demers/Day/Hendricks/Gatto combination teaches the method of claim 16, wherein the method comprises creating an interstitial channel for inserting the wire and the first end of the ultrafine needle into the object (Gatto, [0006]: “a physician can use a guidewire to assist the cannula or catheter in order to find the desired location in the body tissue. Once the catheter is positioned properly, the guidewire may be withdrawn from the catheter and thereafter an endoscope inserted through a lumen of the catheter.”).
Regarding claim 18, the Sheth/Demers/Day/Hendriks/Gatto combination teaches the method of claim 17, wherein the object is ex vivo tissue or in vivo tissue (Sheth, [0042]: “the system 10 can be integrated into conventional endoscopic systems to enable simultaneously imaging fluorescence and white light in vivo.”).
Regarding claim 20, the Sheth/Demers/Day/Hendriks/Gatto combination teaches the method of claim 15.
However, the Sheth/Demers/Day/Hendriks/Gatto combination does not teach wherein the method further comprises coupling the endoscope apparatus to a rinsing device and providing a rinsing solution to the object prior to performing imaging.
Gatto teaches wherein the method further comprises coupling the endoscope apparatus to a rinsing device and providing a rinsing solution to the object prior to performing imaging ([0074]: “An irrigation channel 605 is also needed to provide saline and other medication or fluids to the distal end 111”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the rinsing device and rinsing solution from Gatto into the method from the Sheth/Demers/Day/Hendriks/Gatto combination, as it allows for the area being imaged to be rinsed before imaging, which will create a clearer image and provide a more comprehensive view of the area.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered .
Applicant's arguments filed 10/02/2025 have been fully considered but they are not persuasive. Applicant states that Sheth does not teach an ultrafine needle, and cites paragraph [0023] of Sheth as stating that the introducer needle has an outer diameter of 1.47 nm. However, this paragraph in Sheth states that this is only one embodiment, and that different types of endoscopes can be used. Sheth specifically states that this is one example, not encompassing every example possible. Sheth also discloses that the needle can be a fiber-optic biopsy needle ([0026]: “a system 10 can include an integrated fiber-optic biopsy needle”). A fiber-optic biopsy needle is considered to be an ultrafine needle, therefore teaching on this limitation. Also, the dimensions that the Applicant refers to as defining an ultrafine needle are not disclosed in claims 1 and 2. As a result, the needle of Sheth is not required to have these dimensions with respect to the rejections of claims 1 and 2. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791