DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status:
Claims 1-91, 93-94, and 96-328 have been canceled.
Claims 350-354 have been withdrawn.
Claims 92, 95, 329-332, 334-349, and 355-356 are pending and examined below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/12/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
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.
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) 92, 95, 331, 332, 342, 343, 349, 355, and 356 is/are rejected under 35 U.S.C. 103 as being unpatentable over US20100084563 to “Ohno”, in view of US2015/0150460 to Krishnaswamy et al. “Krishnaswamy”, further in view of US20110152692 to Nie et al. “Nie” (which was disclosed in the IDS filed on 12/12/2025), further in view US2018/0014764 to Bechtel et al. “Bechtel”, and further in view of US2008/0108869 to Sanders et al. “Sanders”.
Regarding claim 92, Ohno discloses a white light (light source 2 can emit white light, Paragraph 0043) and fluorescence-based imaging device (fluorescence imaging apparatus 1, Paragraph 0043) for visualizing one or more of precancerous cells, cancerous cells, and satellite lesions (abnormal tissue such as lesions, Paragraph 0011), comprising:
at least one excitation light source (first excitation light, Paragraph 0053) configured to excite fluorescence emissions of induced porphyrins in tissue cells (Ohno provides an example in Paragraph 0052-53 of inducing fluorescence of flavin adenine dinucleotide, FAD, but states in the claim language of claim 7, that Porphyrin is also possible);
a filter configured to prevent passage of reflected excitation light and permit passage of emissions having a wavelength corresponding fluorescence emissions of the induced porphyrins in tissue cells (filter 14, Paragraph 0046, that allows transmission of fluorescence in a specific wavelength band, Paragraph 0046, wherein the wavelength band is specific to NADH, collagen, FAD, and porphyrin, Paragraph 0053-0054);
an imaging lens (Figs. 1 or 3, objective lens 13);
an image sensor configured to detect fluorescence emissions of the induced porphyrins in tissue cells (image-acquisition device 15 that acquires the fluorescence signal transmitted through the filter 14); and
a processor configured to receive the detected emissions and to output data regarding the detected filtered autofluorescence emissions of tissue cells and fluorescence emissions of the induced porphyrins in tissue cells of the surgical margin (Paragraphs 0054-0055, video-signal processing unit 16 processes the received information within the spectral band of the filter, and calculates a fluorescence intensity ratio at each pixel).
However, Ohno does not disclose the device is a handheld device with a first portion configured to be held in a user's hand and a second portion configured to be at least partially positioned within a surgical cavity created by removing cancerous cells and/or a tumor and configured to direct light onto a surgical margin of the surgical cavity, and the fluorescence emissions of induced porphyrins are in cancerous tissue cells of the surgical margin.
Krishnaswamy teaches a similar white light and fluorescence-based imaging device (Paragraph 0071, light source 401 of the device has a broad spectrum, or white-light producing element; Paragraph 0083, device also obtains fluorescence emitted by fluorophore in organ as fluorescence image). Krishnaswamy teaches the device can be a handheld probe (Paragraphs 0013, 0076, 0090). Krishnaswamy teaches a portion of the device is configured to be at least partially positioned within a surgical cavity created by removing cancerous cells and/or a tumor (Paragraph 0100, device contains a flexible coherent bundle 652 portion that is inserted into a surgical cavity to investigate suspect tissue that are cut boundaries of tissue where a tumor has been removed; wherein the tumor has been classified by a classifier as different types of cancerous tissue, Paragraph 0053) and configured to direct light onto a surgical margin of the surgical cavity (Using the flexible bundle in the surgical cavity, and applying the method of illumination as described in Paragraph 0098, where light from a source is directed to a spot on the tissue). Therefore the flexible bundle portion of the device would read on the claimed second portion, and since the device is handheld, a portion that is not inserted into the cavity would read on the first portion of the device configured to be held in a user's hand. Krishnaswamy additionally teaches the fluorescence emissions of induced porphyrins are in cancerous tissue cells of the surgical margin (Paragraph 0084, wherein the fluorescent light emitted are from fluorophore in the organ and tumor; Paragraph 0081, wherein the fluorophore is protoporphyrin-IX; and Paragraph 0100 wherein the method includes scanning the surgical cavity for tumor tissue remaining in the bed from which a tumor has been excised, which reads on cancerous tissue of the surgical margin).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Ohno's invention wherein Ohno’s fluorescent device is embodied in a handheld device with a first portion configured to be held in a user's hand, and a second portion configured to be at least partially positioned within a surgical cavity created by removing cancerous cells and/or a tumor and configured to direct light onto a surgical margin of the surgical cavity, and the fluorescence emissions of induced porphyrins are in cancerous tissue cells of the surgical margin, as taught by Krishnaswamy, in order to use a white light and fluorescence based imaging device for verifying complete tumor removal by probing suspect areas in a surgical wound (Paragraph 0090), wherein the surgical wound is a surgical cavity from which a tumor has been excised (Krishnaswamy, Paragraph 0100).
However, the modifications of Ohno and Krishnaswamy do not explicitly disclose not contacting the surgical margin when directing the light onto a surgical margin of the surgical cavity.
Nie teaches a similar handheld probe (Paragraphs 0079, 0084, handheld spectroscopic pen device) that emits light (excitation light, Paragraph 0084) and detects fluorescent signals (Paragraph 0084). Nie teaches in ex vivo studies, a distance of 1 cm was maintained between the handheld spectroscopic pen device tip and the top tissue layer to simulate the pen device position during surgical use, and infers a 1 cm gap between the pen tip and the tissue during surgical use (Paragraph 0082, 0088). Nie further teaches using the handheld spectroscopic pen device tip for the surgical cavity, after resection of a tumor (Paragraph 0094, 0096) to obtain real-time pathology about the margin status of the remaining tumor cavity (Paragraph 0096).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno and Krishnaswamy, wherein the device is configured to not contact the surgical margin when directing the light onto a surgical margin of the surgical cavity, as taught by Nie, since Nie teaches a surgical procedure of removing a tumor, and inspecting the cavity created from the resected tumor to perform real-time pathology about the margin status of the remaining tumor cavity (Paragraph 0094 and 0096), and the tip of the pen is maintained 1cm from the top surface of the tissue during the surgical procedure (Paragraph 0082, 0088), and during the use of the pen the excitation laser light is focused onto the sample of interest (Paragraph 0084), this collectively reads on not contacting the surgical margin of the surgical cavity when directing the light onto the surgical margin of the surgical cavity. The motivation would be that the 1 cm distance between the top surface of margin tissue and the tip of the pen is to direct excitation light onto the surgical margin in the surgical cavity. Additionally, the 1 cm distance between the top surface of margin tissue and the tip of the device appears to be a suggested distance during surgical procedures.
However, the modifications of Ohno, Krishnaswamy, and Nie do not disclose wherein the device comprises a unitary body having a longitudinal axis, and a first end portion configured to be held in a user’s hand, and a second end portion having an elongated length with respect to a width of the second end portion.
Bechtel teaches a similar handheld medical device (Paragraph 0070) used during surgery (laparoscopic surgery, Paragraph 0076) that is inserted into a patient’s body cavity (Paragraph 0070) and emit light into tissue and collect light reflected from the tissue (Paragraph 0069). Bechtel teaches wherein the device comprises a unitary body (Abstract, laparoscopic medic device…the device can be a unitary design) having a longitudinal axis (See Figs. 1 or 2, length of probe), and a first end portion configured to be held in a user’s hand (Paragraph 0070, probe unit is adapted to be held, which as seen in Fig. 1, probe unit 105 is positioned at the top end portion of the device), and a second end portion having an elongated length with respect to a width of the second end portion (See Fig. 1, laparoscopic element 108, has an elongated length with respect to the device) such that the second end portion is configured to be position within a surgical cavity (Paragraph 0070, wherein the laparoscopic element is positioned inside a patient’s cavity, during laparoscopic surgery, Paragraph 0076, wherein the laparoscopic element includes a probe tip, See Fig. 1). Bechtel further teaches that light is emitted to the tissue and reflected light is collected from the probe tip, which reads on the second end portion.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, and Nie, wherein the device comprises a unitary body, as taught by Bechtel, in order for the device to be a self-contained device that is easily held in the hand of a user. Additionally, the use of a one piece construction of the structure, i.e. unitary body, would merely be a matter of obvious engineering choice, see In re Larson in the MPEP 2144.04.V.B. Further, it would have been obvious to have a longitudinal axis, and a first end portion configured to be held in a user’s hand, and a second end portion having an elongated length with respect to a width of the second end portion such that the second end portion is configured to be position within a surgical cavity so that the probe can emit light into the tissue and collect light reflected from the internal tissue (Bechtel, Paragraph 0069).
However, the modifications of Ohno, Krishnaswamy, Nie, and Bechtel do not disclose inductive charging coils for charging the device.
Sanders teaches a similar optical surgical device (Title) that includes a shaft, a handle, and camera assembly coupled to the shaft, and may be provided as a single piece (Abstract), for insertion into the body during surgery (Paragraph 0029). Sanders teaches powering the device with a battery, wherein an inductive charging circuitry may be included in the handle to inductively charge the battery, when placed in a complimentary cradle (Paragraph 0164). [Examiner notes that one of ordinary skill in the art would know that inductive charging circuitry would include inductive charging coils].
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, and Bechtel, wherein the device is powered by a battery and includes inductive charging coils for charging the device, as taught by Sanders, so that the probe power circuitry does not need to be directly attached to an external power source for use and for charging.
Regarding claim 95, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
Ohno discloses wherein the at least one excitation light source emits light having a wavelength of between about 375 nm and about 800 nm (a first excitation light emits a wavelength of 380 nm, a second excitation light emits wavelength at 430 nm, Paragraph 0044).
Regarding claim 331, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92.
Bechtel teaches wherein the second end portion of the unitary body tapers along the longitudinal axis of the unitary body (Paragraph 0069, Bechtel teaches the probe unit and laparoscopic element can be non-separable, wherein the two elements can be made of the same material, Paragraph 00154; Therefore as seen in Figs. 1 and 2, the separation between the probe unit and the laparoscopic element is indicated by the dashed line, and from the illustration, it is apparent that the laparoscopic element is at least partially tapered along the longitudinal axis).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Bechtel, and Sanders, wherein the second end portion tapers along the longitudinal axis, as further taught by Bechtel, in order to maintain a smooth outer surface so as not to abrade the tissue (Paragraph 0012).
Regarding claim 332, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 331.
As disclosed in the claim 92 rejection above, Bechtel teaches the device is used during laparoscopic surgery (Paragraph 0076), wherein the laparoscopic element is positioned inside a patient’s cavity (Paragraph 0070), wherein the laparoscopic element includes a probe tip (See Fig. 1). The laparoscopic term infers that the laparoscopic element is inserted from a surgical incision.
Regarding claim 342, the modifications Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
Bechtel teaches a unitary probe/device (Abstract). In a separate embodiment , Bechtel teaches the laparoscopic element is sterilizable (Paragraph 0016).
However, Bechtel does not disclose that the whole device is sterilizable.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Boyden, and Levy, wherein the unitary body of the device comprises a sterilizable material and the device is configured to be sterilized, as suggested by the embodiments of Bechtel, in order to maintain sterility for the whole device without additional needs for a sterile bag or cover.
Regarding claim 343, the modifications Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
Bechtel teaches the second end portion of the unitary body is articulatable, which reads on a curve, to change an angle of incidence of the excitation light (See Fig. 27, articulation joint 2711, that changes the angle of the sensor head 2757, wherein the sensor head contains an emitter, Paragraph 0026; See also Paragraph 0225).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Bechtel, and Sanders, wherein the second end portion of the unitary body is articulatable to change an angle of incidence of the excitation light, as taught by Bechtel, in order to provide a better angle for the emitter in irradiating the tissue.
Regarding claim 349, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
Bechtel teaches the second end portion of the unitary body is articulatable to change an angle of incidence of the excitation light (See Fig. 27, articulation joint 2711, that changes the angle of the sensor head 2757, wherein the sensor head contains an emitter, Paragraph 0026; See also Paragraph 0225).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Bechtel, and Sanders, wherein the second end portion of the unitary body is articulatable to change an angle of incidence of the excitation light, as taught by Bechtel, in order to provide a better angle for the emitter in irradiating the tissue.
Regarding claim 355, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
As disclosed in the claim 92 rejection above, Nie teaches wherein the second end portion is configured to be positioned adjacent to the surgical margin without contacting the surgical margin (a distance of 1 cm was maintained between the handheld spectroscopic pen device tip and the top tissue layer to simulate the pen device position during surgical use, and infers a 1 cm gap between the pen tip and the tissue during surgical use, Paragraph 0082; wherein the pen device is use to provide intraoperative detection of positive and negative tumor margins around the surgical cavity, Paragraph 0098).
Regarding claim 356, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
As disclosed in the claim 92 rejection above, Bechtel teaches a first end portion and a second end portion as defined by the dashed line in Figs. 1 and 2. The portion above, the dashed line can be defined as the first end portion, and the portion below the dashed line can be defined as the second end portion, wherein the second end portion is longer than the first end portion.
Claim(s) 329, 330, 334-337, 344, 345, and 347 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohno, in view of Krishnaswamy, further in view of Nie, further in view of Bechtel, and further in view of Sanders, as applied to claim 92 above, and further in view of US20170280969A1 to Levy et al. “Levy”.
Regarding claim 329, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
Ohno discloses wherein the at least one excitation light source includes a first light source (Fig. 1, Ref. 7) configured to emit light at a first wavelength (Paragraph 0044, light source 7 emits excitation light at 380 nm);
the at least one excitation light source includes a second light source (Fig. 1, Ref. 9) configured to emit light at a second wavelength, different from the first wavelength (Paragraph 0044, light source 9 emits white light);
the at least one excitation light source further includes a third excitation light source (Fig. 1, Ref. 8) that emits light at a third wavelength, different from the first wavelength and the second wavelength (Paragraph 0044, light source 8 emits excitation light at 430 nm); and
the third excitation light source is positioned adjacent to the first and second excitation light sources (See Fig. 1, position of sources 7, 8, and 9 in light source unit 2).
Ohno further discloses the light sources can be an LED (Paragraph 0059).
However, Ohno do not disclose exciting tissue that contain a dye.
Krishnaswamy teaches exciting tissue that contain a dye (Paragraph 0081, administering a fluorescent dye to the organ and tumor 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 have modified the system as described by Ohno, Krishnaswamy, Bechtel, and Sanders, wherein the excitation of tissue is tissue that contain a dye, as further taught by Krishnaswamy, in order to aid the excitation of fluorophores that concentrates in tumor (Krishnaswamy, Paragraph 0081).
However, Ohno and Krishnaswamy do not disclose wherein the dye is infrared or near infrared.
Nie teaches wherein the dye is infrared or near infrared (Paragraph 0076, “The handheld spectroscopic pen device and near-infrared contrast agents are used for intra-operative detection of malignant tumors, based on wavelength-resolved measurements of fluorescence and surface-enhanced Raman scattering (SERS) signals”; also see Paragraph 0098).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, and Sanders, wherein the light source is configured to excite tissue that contain near-infrared or infrared dye, as taught by Nie, in order to be able to detect both positive and negative tumor margins around the surgical cavity, after surgery (i.e. after the tumor is removed) (Paragraph 0076).
However, Ohno, Krishnaswamy, Nie, Bechtel, and Sanders do not disclose wherein the light sources each comprise a plurality of LEDs.
Levy teaches a system where a first light guide is directing light, out from the front face of the endoscopic tip, a second light guide for directing light out a first lateral side of the endoscopic tip, and a third light guide for direct light out a second lateral side opposite from the first lateral side each light guide is isolated from the other. Levy further discloses, using LEDs, in side of the light guides, wherein as can be seen in Fig. 1J, each of the first, second, and third groupings corresponding to the front face, first lateral side, and second lateral side, comprise a plurality of LEDs (Refs. 183, 176, and 189).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, and Sanders, wherein the light sources each comprise a plurality of LEDs, as taught by Levy, since Levy states that is known to use light emitting diodes (LEDs) in place of fiber optics with remote light source (Paragraph 0403), and as such would be a simple substitution of one known element (illumination system using fiber optics to deliver light from a remote source) for another (LEDs) to obtain predictable results (provide illumination out the tip of the device) (see MPEP 2143).
Further, Levy teaches at least one of the LEDs can emit in the infrared range (Paragraph 0585).
Regarding claim 330, Ohno, Krishnaswamy, Nie, Bechtel, Sanders, and Levy disclose all the features of claim 329.
Krishnaswamy teaches measuring the intensity of the pixel from the obtained images at six different wavelengths, between 400-700 nanometer range (Paragraph 0066). This range includes red, green, and near-infrared filter bands.
Therefore, It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, Sanders, and Levy, wherein the filter of Ohno, includes red, green, and near-infrared to infrared filter bands, as suggested by Krishnaswamy, in order to measure the intensity at six discrete wavelengths in the 400-700nm range, such that the pixels can be classified as normal organ tissue, rapidly proliferating tumor tissue, mature tumor tissue, fibrotic tissue, and necrotic tissue (Krishnaswamy, Paragraphs 0066, 0068).
Regarding claims 334, 335, 336, and 337, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
As disclosed in the claim 92 rejection above, Ohno, in view of Krishnaswamy discloses excitation light is delivered using a flexible bundle to the surgical cavity (Ohno, Paragraph 0053, Krishnaswamy, Paragraph 0100), and Bechtel teaches that light is emitted from the portion of the unitary body that is positioned in the surgical cavity (Bechtel, Paragraphs 0069-0070), and would read on a second end portion.
However, the modifications of Ohno, Krishnaswamy, Bechtel, and Sanders do not disclose wherein the excitation light source is positioned on a tip portion of the second end portion of the unitary body of the device, wherein the at least one light source is positioned around a perimeter of the second end portion of the unitary body of the device and/or on an end face of the second end portion of the unitary body of the device.
Levy teaches a system where a first light guide is directing light, out from the front face of the endoscopic tip, a second light guide for directing light out a first lateral side of the endoscopic tip, and a third light guide for direct light out a second lateral side opposite from the first lateral side each light guide is isolated from the other. Levy further discloses, using LEDs, instead of the light guides, wherein as can be seen in Fig. 1J, each of the first, second, and third groupings corresponding to the front face, first lateral side, and second lateral side, comprise a plurality of LEDs (Refs. 183, 176, and 189).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, and Sanders, wherein the excitation light source is positioned on a tip portion of the second end portion of the unitary body of the device, wherein the at least one light source is positioned around a perimeter of the second end portion of the unitary body of the device and/or on an end face of the second end portion of the unitary body of the device, as taught by Levy, since Levy states that is known to use light emitting diodes (LEDs) in place of fiber optics with remote light source (Paragraph 0403), and as such would be a simple substitution of one known element (illumination system using fiber optics to deliver light from a remote source) for another (LEDs) to obtain predictable results (provide illumination out the tip of the device) (see MPEP 2143).
Regarding claim 344, the modifications of Ohno, Krishnaswamy, Bechtel, and Sanders disclose all the features of claim 92 above.
However, Ohno, Krishnaswamy, Bechtel, and Sanders do not disclose wherein the imaging lens is a wide-angle imaging lens or a fish-eye lens.
Levy discloses the imaging lens are wide angle objections, Paragraphs 0749-750.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Bechtel, and Sanders, wherein the imaging lens is a wide-angle imaging lens or a fish-eye lens, as taught by Levy, in order to have a wide acceptance angle for capturing imaging signals (Paragraph 0750).
Regarding claim 345, the modifications of Ohno, Krishnaswamy, Bechtel, Sanders, and Levy disclose all the features of claim 344 above.
Ohno teaches wherein the imaging lens is positioned on a distal tip of the device to focus emission to be received by the image sensor (See Fig. 1, object lens 13 at the distal tip, See also Paragraph 0046).
Regarding claim 347, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, Sanders, and Levy disclose all the features of claim 330 above.
Levy discloses a plurality of buttons on the endoscopic handle that causes recording a video and capturing a still image (Paragraph 1170).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, Sanders, and Levy, wherein the device includes controls for at least one of image mode/video mode, as taught by Levy, in order to order to have control via the handle when to capture a video, and when to capture an image or still (Paragraph 1170).
Claim(s) 338, 339, and 341 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohno, in view of Krishnaswamy, further in view of Nie, further in view of Bechtel, further in view of Sanders, and further in view of Levy, as applied to claim 337 above, and further in view of US2013/0281845 to “Luiken”.
Regarding claims 338 and 339, the modifications of Ohno, Krishnaswamy, Ni, Bechtel, Sanders, and Levy disclose all the features of claim 337, above, including at least one light source at the tip portion of the second end portion of the unitary body of the device.
However, Ohno, Krishnaswamy, Ni, Bechtel, Sanders, and Levy do not disclose wherein the at least one light source includes a first plurality of LEDs positioned around a perimeter of the tip portion, wherein the first plurality of LEDs is positioned in alternating fashion with a second plurality of LEDs around the perimeter of the tip portion of the second end portion of the unitary body of the device, wherein each of the first plurality of LEDs is configured to emit excitation light and each of the second plurality of LEDs is configured to emit white light.
Luiken teaches a similar endoscopic device with a plurality of light sources for illuminating and imaging white light and fluorescent targets (Abstract). Luiken teaches a ring of a plurality of alternating blue and white LED light sources (Paragraph 0011), wherein the blue LEDs emit blue excitation light for allowing green fluorescent emission (Paragraph 0010) and would read on excitation lights. As seen in Fig. 1, the alternating blue and white LEDs are arranged at the face of the tip of endoscopic device 10.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, Sanders, and Levy, wherein the at least one light source includes a first plurality of LEDs positioned around a perimeter of the tip portion, wherein the first plurality of LEDs is positioned in alternating fashion with a second plurality of LEDs around the perimeter of the tip portion of the second end portion of the unitary body of the device, wherein each of the first plurality of LEDs is configured to emit excitation light and each of the second plurality of LEDs is configured to emit white light, as taught by Luiken, in order to be able to obtain locate diseased tissue by excitation of fluorophores and white light.
Regarding claim 341, the modifications of the modifications of Ohno, Krishnaswamy, Nie, Bechtel, Sanders, Levy, and Luiken disclose all the features of claim 339 above.
Levy discloses a heat sink associated with each light source or each LED (Paragraph 0680, metal frames 2904, 2910, and 2912 serve as heat sinks for the light emitting diodes, wherein each metal frame is associated with the LEDs of a particular directional grouping (See Paragraph 0680 and Fig. 29A).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, Sanders, Levy, and Luiken, wherein a heat sink is associated with each light source or each LED, as taught by Levy, in order to dissipate the heat generated by the light sources.
Claim(s) 340 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohno, in view of Krishnaswamy, further in view of Nie, further in view of Bechtel, further in view of Sanders, as applied to claim 92 above, and further in view of US20170143418 to “Lee”.
Regarding claim 340, the modifications of Ohno, Krishnaswamy, Bechtel, and Sanders disclose all the features of claim 92 above.
However, the modifications of Ohno, Krishnaswamy, Bechtel, and Sanders do not explicitly disclose one or more image preserving fibers or fiber bundles positioned in the unitary body to transmit light and/or image data from the image lens to the image sensor.
Lee teaches one or more image preserving fibers or fiber bundles positioned in the unitary body to transmit light and/or image data from the image lens to the image sensor (receiving fiber optic cables, 43R, to receive collected light, Paragraph 0013, which is transmitted via the receiving fiber optic cables to a detection component 130, Paragraph 0081, comprises a quantification component such as a CCD or CMOS detector Paragraph 0082; See also Fig. 13).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, and Sanders, wherein one or more image preserving fibers or fiber bundles positioned in the body to transmit light and/or image data to the image sensor, as taught by Lee, in order to allow translation of measured light intensities into an electrical signal that can be processed with a computer and displayed graphically to an operator, Paragraph 0082. Further, using fiber optics to send received light to are detector is well known to one of ordinary skill in the art, and as such would be a simple substitution of one known element (detector at the distal tip) for another (using fiber optics to deliver light from to a remote detector) to obtain predictable results (detecting received light signals) (see MPEP 2143).
Claim(s) 346 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohno, in view of Krishnaswamy, further in view of Nie, further in view of Bechtel, further in view of Sanders, as applied to claim 92 above, and further in view of US20060241493 Feldman et al. “Feldman”.
Regarding claim 346, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
However, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders do not disclose wherein the image sensor has single cell resolution.
Feldman teaches wherein the image sensor has single cell resolution (Paragraph 0083, single cell resolution using OCT, wherein the probe is part of an OCT imaging system, and light signals collected by the probe are transmitted to an analyzer of the OCT system, See Fig. 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, and Sanders, wherein the image sensor has single cell resolution, as taught by Feldman, in order to provide histologic images without the need to biopsy tissue to visualize and diagnose cancer in real time (Paragraph 0083).
Claim(s) 348 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ohno, in view of Krishnaswamy, further in view of Nie, further in view of Bechtel, further in view of Sanders, as applied to claim 92 above, and further in view of US2022/0071559 Jones et al. “Jones”.
Regarding claim 348, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders disclose all the features of claim 92 above.
However, the modifications of Ohno, Krishnaswamy, Nie, Bechtel, and Sanders do not disclose an ambient light sensor configured to indicate when fluorescence imaging conditions are appropriate.
Jones teaches a similar in body device (endoscopic capsule, Paragraph 0091), that includes an ambient light sensor configured to indicate when fluorescence imaging conditions are appropriate (detector 122 gathers measurements of ambient light, to determine if device is in the proper location, Fig. 5, step 502; and if in proper location, proceed to obtaining reflectance measurements, See Fig. 5; wherein the measurements include fluorescence and autofluorescence, Paragraph 0496).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ohno, Krishnaswamy, Nie, Bechtel, and Sanders, wherein an ambient light sensor configured to indicate when fluorescence imaging conditions are appropriate, as taught by Jones, in order to obtain reflectance measurements for a desired region, based on the detected ambient light.
Response to Arguments
Applicant’s arguments with respect to claim(s) 92, 95, 329-332, 334-349, and 355-356 have been considered but are moot because the new ground of rejection does not rely on any combinations of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
However, the examiner will address the pertinent remaining arguments.
Applicant argues in arguments filed 12/12/2025, on Page 3, that Krishnaswamy does teach that the second end portion of the device is configured to direct light onto a surgical margin of the surgical cavity without contacting the surgical margin. Applicant contends that cited Paragraph 0100 by examiner, which refers to the device of Fig. 10, actually teaches the device of Fig. 10 to contact the tissue, and as such, Krishnaswamy does not include the claim limitation "configured to direct light onto a surgical margin of the surgical cavity without contacting the surgical margin.”
Although in the current new grounds of rejection (due to using prior art to Nie as disclosed in the IDS filed on 12/12/2025), the examiner responds that Krishnaswamy is capable of directing light onto a surgical margin of the surgical cavity without contacting the surgical margin. Although Krishnaswamy teaches contacting the tissue in certain alternative embodiments (Abstract: “a scanner coupled to a coherent optical bundle that may be placed in contact with tissue”; Paragraph 0100, “In another embodiment, the second end 654 of the coherent bundle 652 is slightly roughened to minimize internal reflections and improve tissue contact”; Paragraph 0111, “ In an alternative embodiment, intended for direct contact with tissue), no teachings, outside the two specific embodiments in Paragraph 0100 and Paragraph 0111, require contacting the tissue to direct light onto the tissue. Further, the embodiment at the start of Paragraph 0100, which the examiner cites features from, appears to be different from the embodiment at the end of Paragraph 0100, which recites the direct tissue contact (Paragraph 0100: “Apparatus for scanning tissue at edges of a surgical wound is illustrated in FIG. 10. In this embodiment…In another embodiment, the second end 654 of the coherent bundle 652 is slightly roughened to minimize internal reflections and improve tissue contact). This appears to be further supported in the abstract Krishnaswamy stating “a scanner coupled to a coherent optical bundle that may be placed in contact with tissue along boundaries of an operative wound”. There does not appear to be any teachings in Krishnaswamy, that indicates that the device of Fig. 10, as initially presented at the first portion of Paragraph 0100, could not direct light onto a surgical margin of the surgical cavity without contacting the surgical margin, and additionally, the limitations of the claim 92 do not indicate any structural features different from Krishnaswamy that would prevent the Fig. 10 device of Krishnaswamy to perform the contended limitation.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 12/12/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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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/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798