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 .
Response to Arguments
Applicant's arguments filed 05/12/2026 have been fully considered but they are not persuasive.
Rejections under 35 USC 112 have been withdrawn.
Rejections under 35 USC 102 have been withdrawn. However, previously-found reference of Onobiri and newly-found reference of Seibel have been introduced; therefore, 103 rejections have been maintained.
Applicant argues, see Applicant’s arguments pages 8-11, that the combination of Yampolsky and Onobiri fail to teach the full scope of amended claim 1. Examiner disagrees that Yampolsky does not teach generating fluorescence light for fluorescence-guided surgery. Paragraph [0113] teaches that the light sources may generate fluorescence light; this is further supported by [0127], which details specific fluorescent contrast agents that may be used. The limitation “for fluorescence-guided surgery” is intended use, but since Yampolsky teaches utilizing fluorescence imaging and performing surgical procedures using the instrument, Examiner asserts that one having ordinary skill in the art would understand that the instrument of Yampolsky can be used for fluorescence-guided surgery. Yampolsky, however, does not teach multiple light sources, so Onobiri is used to teach this limitation.
Examiner agrees that Onobiri does not teach that the filter is at the distal end of the endoscope. Newly-found reference of Seibel has been introduced to teach this limitation.
Regarding Applicant’s argument that Onobiri does not teach that the optical fibers connect a proximal and distal end of the endoscope and the phosphor is arranged at the distal end of the endoscope, Onobiri is not relied upon to teach these limitations. Examiner upholds the use of Yampolsky to teach these limitations.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claim 21 is objected to because of the following informalities: “fluorescence guided surgery” should read –fluorescence-guided surgery--; and “the range of 830 nm to 900 nm” should read –a range of 830 nm to 900 nm--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Rejections under 35 USC 112 have been withdrawn in response to Applicant’s amendments filed 05/12/2026.
Claim Rejections - 35 USC § 102
Rejections under 35 USC 102 have been withdrawn in response to Applicant’s amendments filed 05/12/2026.
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 1-6, 10, 12, & 15-21 are rejected under 35 U.S.C. 103 as being unpatentable over Yampolsky (US 2021/0093412) in view of Onobiri (US 2023/0240521) and Seibel (US 2008/0221388).
Regarding claim 1, Yampolsky teaches an endoscope (medical instrument 510, [0115]) comprising:
a set of one or more optical fibers (optical fiber 518, [0115]) connecting a proximal end of the endoscope to a distal end of the endoscope (Figure 21), wherein the set of one or more optical fibers is arranged to receive, at the proximal end of the endoscope, first light generated by a first light source (light source 520, [0115], Figure 21) and fluorescence excitation light ([0113] & [0127]) for fluorescence-guided surgery ([0127]); and
a phosphor (phosphor, [0115]) arranged at the distal end of the endoscope ([0115], Figure 21) to:
receive the first light from the set of one or more optical fibers ([0115], Figure 21), and emit light having a different spectrum to the first light ([0115]); and
receive the fluorescence excitation light from the set of one or more optical fibers ([0113]), and scatter the fluorescence excitation light ([0126]).
However, Yampolsky fails to disclose: a second light source; and a filter arranged to filter the fluorescence excitation light to attenuate components of the fluorescence excitation light at a fluorescence detection wavelength.
Onobiri teaches:
a second light source (light source 1, [0028]); and
a filter (optical filter, [0052]) arranged to filter the fluorescence excitation light to attenuate components of the fluorescence excitation light at a fluorescence detection wavelength ([0052] & [0059]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky to include: a second light source; and a filter arranged to filter the fluorescence excitation light to attenuate components of the fluorescence excitation light at a fluorescence detection wavelength, as taught by Onobiri. An additional light source increases the wavelength range the endoscope is able to produce, as different wavelengths carry different advantages. Because fluorescent agents emit fluorescence at a different wavelength than the wavelength that excites them, filtering out the detection wavelength from the excitation light ensures that any detection wavelength detected is from the fluorosphere, and not the phosphor.
However, Yapolsky in view of Onobiri fail to disclose that the filter is at the distal end of the endoscope.
Seibel teaches that the filter (emission filter, [0060]) is at the distal end of the endoscope ([0060]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky and Onobiri such that the filter is at the distal end of the endoscope, as taught by Seibel. Placing the filter at the distal end of the endoscope eliminates the possibility of any interference along the length of the fiber.
Regarding claim 2, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches a light interface (one or more optical elements, [0118]) configured to receive the first light generated by the first light source and provide the first light to the set of one or more optical fibers at the proximal end of the endoscope ([0118]).
Regarding claim 3, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches that the first light source is a laser ([0118]).
Regarding claim 4, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches that the diameter of the set of one or more optical fibers is less than 500 µm ([0120]), and wherein the endoscope is flexible along at least a portion of its length from the proximal end to the distal end ([0130]).
Regarding claim 5, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches that the spectrum of the first light generated by the first light source has a peak within a range of wavelengths from 400 nm to 500 nm ([0125] & [0132]), and wherein the light emitted from the phosphor has a wider range of wavelengths than the first light generated by the first light source ([0132]).
Paragraph [0132] details the range of wavelengths that a specific color may have. Because white is the presence of all visible spectrum wavelengths, the white light emitted by the phosphor has a wider range of wavelengths than the blue light source.
Regarding claim 6, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches that according to a human visual system, the first light generated by the first light source is perceived to be blue light ([0125] & [0132]) and the light emitted from the phosphor is perceived to be white light ([0119], [0125], & [0132]).
Regarding claim 10, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches that the set of one or more optical fibers has just a single optical fiber ([0115] & Figure 21).
Regarding claim 12, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Onobiri further teaches that the second light source is a laser ([0032]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky such that the second light source is a laser, as taught by Onobiri. The light source in Yampolsky is a laser, so making the second light source a laser when incorporating the teachings of Onobiri into Yampolsky would be the most obvious option.
Regarding claim 15, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Onobiri further teaches that the second light source generates the fluorescence excitation light with a different peak wavelength to the peak wavelength of the first light generated by the first light source ([0028]-[0029]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky such that the second light source generates the fluorescence excitation light with a different peak wavelength to the peak wavelength of the first light generated by the first light source, as taught by Onobiri. There are different advantages to different wavelengths, so using multiple wavelengths allows the endoscope to have a greater versatility in imaging.
Regarding claim 16, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Onobiri further teaches that the second light source generates the fluorescence excitation light with a wavelength in a range from 700 nm to 850 nm ([0051]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky such that the second light source generates the fluorescence excitation light with a wavelength in a range from 700 nm to 850 nm, as taught by Onobiri. Infrared light penetrates tissue deeper than light in the visible spectrum, so this allows for a greater range of imaging.
Regarding claim 17, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches that the endoscope is a surgical endoscope configured to illuminate and image ([0127]) a surgical site during a surgical operation ([0114]).
Regarding claim 18, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 17, and Yampolsky further teaches that the endoscope is further configured to detect fluorescently-labelled structures during fluorescence-guided surgery ([0127]).
Regarding claim 19, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches that the proximal end of the endoscope is configured to be attached to a distal end of a surgical robot arm (one or more robotic arms 12, [0035], Figure 1).
Claim 20 is rejected for similar reasons to claim 1.
Regarding claim 21, Yampolsky teaches a system comprising:
a first light source (light source 520, [0115], Figure 21) configured to generate first light ([0115]), the spectrum of the first light having a peak within a range of wavelengths from 400 nm to 500 nm ([0125] & [0132]); and
an endoscope (medical instrument 510, [0115]), the endoscope comprising:
a set of one or more optical fibers (optical fiber 518, [0115]) connecting a proximal end of the endoscope to a distal end of the endoscope (Figure 21), wherein the set of one or more optical fibers is arranged to receive, at the proximal end of the endoscope: (i) the first light generated by the first light source ([0115]), and (ii) fluorescence excitation light ([0113] & [0127]); and
a phosphor (phosphor, [0115]) arranged at the distal end of the endoscope ([0115], Figure 21) to:
receive the first light from the set of one or more optical fibers ([0115], Figure 21), and emit light having a different spectrum to the first light ([0115]); and
receive the fluorescence excitation light from the set of one or more optical fibers ([0113]), and scatter the fluorescence excitation light ([0126]); and
a fluorescence detection wavelength is in a range of 830 nm to 900 nm ([0127]).
Paragraph [0127] states that the contrast agent ICG may be used for fluorescence imaging. ICG has a detection wavelength range between 800-850 nm.
However, Yampolsky fails to disclose: a second light source configured to generate fluorescence excitation light for fluorescence-guided surgery with a wavelength in a range from 700 nm to 850 nm; and a filter arranged to filter the fluorescence excitation light to attenuate components of the fluorescence excitation light at a fluorescence detection wavelength.
Onobiri teaches:
a second light source (light source 1, [0028]) configured to generate fluorescence excitation light for fluorescence-guided surgery ([0028]) with a wavelength in a range from 700 nm to 850 nm ([0051]); and
a filter (optical filter, [0052]) arranged to filter the fluorescence excitation light to attenuate components of the fluorescence excitation light at a fluorescence detection wavelength ([0052] & [0059]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Yampolsky to include: a second light source configured to generate fluorescence excitation light for fluorescence-guided surgery with a wavelength in a range from 700 nm to 850 nm; and a filter arranged to filter the fluorescence excitation light to attenuate components of the fluorescence excitation light at a fluorescence detection wavelength, as taught by Onobiri. An additional light source increases the wavelength range the endoscope is able to produce, as different wavelengths carry different advantages. For example, infrared light penetrates tissue deeper than light in the visible spectrum so this allows for a greater range of imaging. Because fluorescent agents emit fluorescence at a different wavelength than the wavelength that excites them, filtering out the detection wavelength from the excitation light ensures that any detection wavelength detected is from the fluorosphere, and not the phosphor.
However, Yampolsky in view of Onobiri fail to disclose that the filter is at the distal end of the endoscope.
Seibel teaches that the filter (emission filter, [0060]) is at the distal end of the endoscope ([0060]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system of Yampolsky and Onobiri such that the filter is at the distal end of the endoscope, as taught by Seibel. Placing the filter at the distal end of the endoscope eliminates the possibility of any interference along the length of the fiber.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Yampolsky in view of Onobiri and Seibel, as applied to claim 1, above, in further view of Talbert (US 2020/0397239).
Regarding claim 7, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1, and Yampolsky further teaches that the endoscope further comprises a camera (camera, [0085]-[0086] & [0105]).
However, Yampolsky in view of Onobiri and Seibel fail to disclose that the phosphor is arranged to emit light over a range of angles that is greater than a range of angles included within a field of view of the camera.
Talbert teaches that the phosphor (fiber, [0196]) is arranged to emit light over a range of angles ([0196] & Figure 11) that is greater than a range of angles included within a field of view of the camera (camera, [0202]) ([0196] & [0202]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky, Onobiri, and Seibel such that the phosphor is arranged to emit light over a range of angles that is greater than a range of angles included within a field of view of the camera, as taught by Talbert. This ensures that the entire field of view of the camera is illuminated and able to receive image data.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yampolsky in view of Onobiri and Seibel, as applied to claim 1, above, in further view of Koenig (US 2008/0081950).
Regarding claim 8, Yampolsky in view of Onobiri and Seibel teach the endoscope of claim 1.
However, Yampolsky in view of Onobiri and Seibel fail to disclose that the endoscope further comprises one or more mirrored surfaces at the distal end of the endoscope, positioned around the phosphor to reflect light that is emitted backwards from the phosphor.
Koenig teaches that the endoscope further comprises one or more mirrored surfaces (mirror coating 10, [0098], Figure 6) at the distal end of the endoscope ([0098], Figure 6), positioned around the phosphor (fiber 4, [0098]) ([0098], Figure 6) to reflect light that is emitted backwards from the phosphor (Figure 6).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky, Onobiri, and Seibel such that the endoscope further comprises one or more mirrored surfaces at the distal end of the endoscope, positioned around the phosphor to reflect light that is emitted backwards from the phosphor, as taught by Koenig. This ensures that any light emitted backwards can reflect forward from the endoscope, increasing the amount of light present in the object being imaged.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yampolsky in view of Onobiri, Seibel, and Koenig, as applied to claim 8, above, in further view of Bornstein (WO 2010/019800).
Regarding claim 9, Yampolsky in view of Onobiri, Seibel, and Koenig teach the endoscope of claim 8, and Koenig further teaches that said one or more mirrored surfaces form an open cylinder around the phosphor (Figure 6), with the one or more mirrored surfaces comprising: one or more other mirrored surfaces forming side walls of the open cylinder around the phosphor ([0098], Figure 6).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky, Onobiri, and Seibel such that said one or more mirrored surfaces form an open cylinder around the phosphor, with the one or more mirrored surfaces comprising: one or more other mirrored surfaces forming side walls of the open cylinder around the phosphor, as taught by Koenig. This ensures that any side-propagated light can reflect forward from the endoscope.
However, Yampolsky in view of Onobiri, Seibel, and Koenig fail to disclose a first mirrored surface, which is flat and circular, and positioned behind the phosphor, wherein the first mirrored surface has a hole in which a portion of the set of one or more optical fibers is positioned.
Bornstein teaches a first mirrored surface (first mirror 18; Page 124, Line 27; Figure 26), which is flat and circular (Figure 26), and positioned behind the phosphor (optical fiber 12, Page 124, Lines 26-27) (Figure 26), wherein the first mirrored surface has a hole (aperture 24; Page 124, Line 29; Figure 26) in which a portion of the set of one or more optical fibers is positioned (Page 124, Lines 28-29; Figure 26).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the endoscope of Yampolsky, Onobiri, Seibel, and Koenig to include a first mirrored surface, which is flat and circular, and positioned behind the phosphor, wherein the first mirrored surface has a hole in which a portion of the set of one or more optical fibers is positioned, as taught by Bornstein. This ensures that any back-propagated light can reflect forward from the endoscope, while the hole allows the fiber to be completely surrounded, preventing any loss of light.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798