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 .
Election/Restrictions
Applicant’s election without traverse of election of species and/or subspecies A1g, B1, and C4, in the reply filed on 04/24/2026 is acknowledged.
Claims 8, 10-14, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and/or subspecies AIc, AId, AIe, B2, C5, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 04/24/2026.
Claim Objections
Claim 1 is objected to because of the following informalities: the limitations “providing a tissue detection system including an optical system and a surgical instrument for resecting tissue…”, “creating an access hole having a first width through a tissue of the patient and extending to a surgical site of the patient”, “accessing the surgical site through the access hole and resecting tissue at the surgical site of the patient…” should be amended to recite “providing a tissue detection system including an optical system and a surgical instrument for resecting a tissue…, wherein the tissue to be resected is different than the obscure tissue ”, “creating an access hole having a first width through [[a]]the tissue of the patient and extending to a surgical site of the patient” and “accessing the surgical site through the access hole and resecting the tissue at the surgical site of the patient….” in order to avoid future rejections regarding clarity issues with the claims. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the limitations “displacing tissue without resecting the tissue” and “positioning the distal end of the surgical instrument in contact with a second portion of the obscure tissue wall displacing tissue within the resection cavity” should be amended to recite “displacing the tissue without resecting the tissue” and “positioning the distal end of the surgical instrument in contact with a second portion of the obscured tissue wall displacing the tissue within the resection cavity” in order to avoid future rejections regarding clarity issues with the claims. Appropriate correction is required.
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.
Claim(s) 1-3, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Leblond et al. (US20160151055, hereafter “Leblond”), in view of DaCosta et al. (US20220248944, hereafter “DaCosta”), further in view of Inoue et al. (US20150238085, hereafter “Inoue”).
Regarding claim 1, Leblond discloses a surgical method of assessing tumor of tissue of a patient who was administered a fluorescing agent ([0061], [0079] using an exogenous fluorophore), the method comprising:
providing* a tissue detection system including an optical system and a surgical instrument for resecting tissue ([0069]-[0071] biopsy device allows for signal detection from tissue), the surgical instrument (318 in FIG. 9) including at least one optical fiber extending to a distal end of the surgical instrument (326 in FIG. 9) for transmitting excitation light and for receiving fluorescent emissions from the tissue ([0064] the optical fibers are for illuminating a surrounding tissue with an optical signal or for receiving an optical signal response from the surrounding tissue);
providing* a surgical imaging system which has a field of view ([0008] integrated with a spectroscopic biopsy system having a field of view);
creating** an access hole (abstract performing a biopsy) having a first width (equal to cutting window 114 in FIG. 1) through a tissue of the patient and extending to a surgical site of the patient ([0062], FIG. 1, the sample/tissue receiving window 114 has cutting edges, such that manipulations of the device 110 may allow samples of the tissue to be cut with the cutting edges);
accessing*** the surgical site through the access hole and resecting tissue at the surgical site of the patient with the surgical instrument to create a resection cavity having a second width which is larger than the first width ([0067]-[0068], FIGS. 3A-3C, the biopsy device 110 is manipulated to remove/resect the sample 154 of the tumor in the surrounding tissue 156 by suctioning it into the inner cavity 120 or by using cutting edges delimiting the window to remove the sample, thus once the tumor is removed, this results in a resection cavity having a second width which is larger than the first width) at least a portion of the resection cavity being outside of the field of view of the imaging device and including the tissue ([0008], [0062]-[0066] images are produced using the detected signals of the tissue surrounding the device in order to detect the included tumor core tissue, and, the blood vessels nearby outside of the field of view);
positioning the surgical instrument through the access hole and within the resection cavity such that the surgical instrument is in contact with the obscured tissue (see FIGS. 3A-3C);
collecting**** fluorescent emission from the tissue using the at least one optical fiber of the surgical instrument ([0064] optical fibers used to for fluorescence measurement of the interrogated tissue); and
controlling an indicatorꝉ of the tissue detection system based on the fluorescent emissions from the tissue as collected by the at least one optical fiber of the surgical instrument ([0026], [0075]-[0076], FIG. 13, the determined optical property being indicative of fluorescence occurring in the surrounding tissue displayed on the output device to a surgeon); but method disclosed by Leblond is not explicitly disclose as being a method for assessing tumor margins of obscured tissue nor that the surgical device as having a handle portion, and a shaft extending from the handle portion.
However, in the same field of endeavor, DaCosta teaches assessing tumor margins of obscured tissue ([0002], [0151] assessing the surgical margins such as tissue margins on excised tumors and margins on tissue beds/surgical beds within surgical cavities from which a tumor and/or tissue has been removed using fluorescence lifetime imaging of tissue to identify and differentiate between different [obscure and non-obscured] tissue components, including health and diseased tissues); and
a surgical device with a handle portion, and a shaft extending from the handle portion (shaft 140 extending from handle portion 110 in FIG. 4, [0060] the device is handheld).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Leblond with the method being directed to assessing tumor margins of obscured tissue, the surgical device including a handle portion as taught by Inoue in order to provide guidance for removal of one or more of residual cancer cells, precancerous cells, and satellite lesions by means of a a portable, modular endoscopic handheld imaging system ([0006] and [0012] of DaCosta).
Leblond does not explicitly disclose the imaging system disclosed by Leblond is not explicitly disclose as being a surgical microscope; the issue being obscured tissue; nor
However, in the same field of endeavor, Inoue teaches providing a surgical microscope which has a field of view ([0019] excitation/fluorescence detection in the field of view of the surgical microscope); the tissue is obscured tissue ([0020] the tissue is obscured tissue in that it is difficult to observe with the naked eye due to tissue autofluorescence of adjacent tissue).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Leblond with providing a surgical microscope which has a field of view as taught by Inoue in order to surgical microscope having a fluorescence diagnosis mode, in which an excitation light irradiation/fluorescence detection optical fiber with a collimator connected thereto is incorporated as a probe, enables identification of, in particular, a low-invasion site around a tumor part that is difficult to observe by the naked eye ([0022] of Inoue).
*For the purposes of examination, the term of these limitations has been interpreted under the broadest reasonable interpretation henceforth as defined by Oxford learner’s dictionary to mean a conjunction: “providing (that)… used to say when must happen or be done to make it possible for something else that happen” and to mean any step performed by any functional or physical means known in the surgical arts that is performed in conjunction with a functional operation in the form of digital commands/software, or physical system(s) for tissue detection, tissue resection, and and surgical imaging.
**For the purposes of examination, the term of the limitation has been interpreted under the broadest reasonable interpretation henceforth to mean to be performed by any means known in the surgical art in which a whole by which a surgical device may be have access to an internal cavity of patient tissue.
***For the purposes of examination, the term of the limitation has been interpreted under the broadest reasonable interpretation henceforth to mean a step performed by any means known in the surgical arts including, but not limited to any functional/software or computer-implemented step or physical step performed by a device or operator is able to resect tissue at the surgical site.
****For the purposes of examination, the term of the limitation has been interpreted under the broadest reasonable interpretation henceforth to mean a functional step which is performed by any means known in the surgical arts, including, but not limited to any functional/software or computer-implemented function and/or any number of computer, and the omitted modules and or hardware/physical devices used in conjunction or alone in performing this limitation.
ꝉFor the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation henceforth to be any means known in the surgical art, including, but not limited to any known physical device or software or computer-implemented function, which is capable of being controlled or output in such a way that is dependent on the fluorescent emissions from the obscured tissue as collected by the at least one optical fiber of the surgical instrument, , the controlling or controlled output being performed by any means known in the surgical arts, including but not limited to a software or computer-implemented function or by means of a physical user or physical/hardware device.
Regarding claim 2, Leblond, in view of Inoue, substantially discloses all the limitations of the claimed invention, specifically, Leblond discloses wherein:
the resection cavity includes a first resection volume and a second resection volume ([0008], [0077] the biopsy device is in a tissue volume, portions of which are removed, therefore the portions which are removed or resected correspond to a first and second volume); and
specifically, Inoue discloses the second resection volume is outside of the field of view of the surgical microscope and includes the obscured tissue ([0054] the collimator is actual in contact with the obscured tissue, enabling efficient detection of red fluorescence produced by the obscured lymph node metastasis/second resected volume, which is covered/obscured by fat); and
positioning the surgical instrument in contact with the obscured tissue includes positioning the surgical instrument at least partially outside of the field of view of the surgical microscope and in contact with a portion of the second resection volume ([0022], [0054] a fluorescence detection sensitivity equivalent to that in a case where irradiation is provided with the irradiation portion of the optical fiber brought close to the diseased tissue can be obtained as the collimator is actual in contact with a tissue, thus enabling efficient detection of red fluorescence produced by the obscured lymph node metastasis, which is covered/obsefcured by fat).
Regarding claim 3, Leblond, substantially discloses all the limitations of the claimed invention, specifically, Leblond discloses wherein the surgical instrument is a suction tool configured to couple to a vacuum source and apply a suction force to the surgical site (see FIG.3C device in suction mode applying suction to surgical site).
Regarding claim 9, Leblond, in view of Inoue, substantially discloses all the limitations of the claimed invention, specifically, Inoue discloses further comprising:
resecting a first portion of the obscured tissue with the surgical instrument ([0053] the surgical instrument is brought in contact with the tissue/blood to push the tissue/blood out of the way which is covering other tissue);
determining that the optical fiber of the surgical instrument no longer detects fluorescent emissions ([0018] when the distance between the distal end of the surgical device and the diseased tissue becomes too long it causes failure and reception/detection of fluorescence);
displacing tissue without resecting the tissue ([0053] as the blood is pushed out of the way and displaced is not resected);
positioning the distal end of the surgical instrument in contact with a second portion of the obscured tissue while displacing tissue within the resection cavity ([0053], [0070] the distal end of the surgical instrument is brought in contact with the tissue and displaces the tissue/blood out of the way with in the resection cavity); and
resecting the first portion of the obscured tissue ([0070] in order to perform removal of brain tumors including peripheral parts of brain tumors and low invasion sites around the tumor parts).
Claim(s) 4-7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Leblond, in view of DaCosta and Inoue, as applied to claim 3 above, and further in view of Ganz et al (US20180344993, hereafter “Ganz”).
Regarding claim 4, Leblond substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the suction tool includes an aperture for controlling the suction force* (i) manually.
However, in the same field of endeavor, Ganz teaches wherein the suction tool includes an aperture for controlling the suction force* (i) manually ([0148], FIG. 29, see suction port 3042 is operated manually with the thumb of the hand of the practitioner).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by Leblond with the suction tool includes an aperture for controlling the suction force as taught by Ganz in order be operated and utilized within a single hand of a practitioner ([0148] of Ganz).
*For the purposes of examination, the limitation has been interpreted in the alternative requiring controlling the suction force manually; or requiring controlling the suction force in response to the indicator of the tissue detection system.
Regarding claim 5, Leblond substantially discloses all the limitations of the claimed invention, specifically, Leblond discloses wherein the surgical suction tool is operable in multiple modes including:
an observation mode in which the surgical suction tool is configured to detect fluorescent emission from the obscured tissue without applying the suction force ([0067], FIG. 3A, the operator maintains the tool in the closed configuration [detection mode] while using optical fibers 126 to determine the optical property of a sample 154 of surrounding tissue 156); and
a resection mode in which the surgical suction tool is configured to detect fluorescent emission from the obscured tissue while applying the suction force ([0067], [0076], [0091], FIGS. 3C, 13 the suction force was applied to perform the biopsy while using one or more of the plurality of optical fibers to simultaneously/concurrently detect fluorescent emission).
Regarding claim 6 Leblond substantially discloses all the limitations of the claimed invention, specifically, Leblond discloses wherein the surgical suction tool is operable in a manual detection mode in which the indicator of the surgical suction tool is disabled and does not respond to detections of fluorescent emission from tissue ([0067], FIGS. 3A-3C, the operator maintains the tool in the closed configuration [detection mode] while using optical fibers 126 to determine the optical property of a sample 154 of surrounding tissue 156, as the measurement has not yet determined if a tumor or fluorescent emission is present in the surrounding tissue being examined, it is understood by one of skill in the art that the indicator is not active as no detections are being made in the elusive example shown in FIG. 3C).
Regarding claim 7, Leblond substantially discloses all the limitations of the claimed invention, specifically, Leblond discloses further comprising:
maintaining the surgical suction tool in the observation mode (see FIG. 3A); and
switching the surgical suction tool from the observation mode to the resection mode based on the fluorescent emission from the obscured tissue as collected by the optical fiber of the surgical suction tool (see signals detected in FIG. 3A, switching to suction mode in FIG. 3B, then in FIG. 3C in suction mode).
Regarding claim 15, Leblond in view of Inoue, substantially discloses all the limitations of the claimed invention, specifically, Inoue discloses that the surgical microscope should be repositioned to change the field of view of the surgical microscope to cause at least a portion of the obscured tissue to be within the field of view ([0066], FIG. 10, the depth/distance of the microscope is readjusted to enable detection of fluorescence at a bottom part of the resection cavity, which has been interpreted to read on the limitation of the obscured tissue as the tissue was obscured from visual inspection prior to the adjustment of the microscope), but is silent on the repositioning being in response to wherein the indicator includes a reposition indicator configured to indicate to a user to preform repositioning.
However, in the same field of endeavor, Ganz teaches wherein the indicator includes a reposition indicator configured to indicate to a user that to preform repositioning ([0208], FIGS. 45, indicators 4084 provide a visual cue to a user to indicate the depth of the distal tip and where it is inserted in the patient, as some indicators may be a minimum depth indicator practitioner can evaluate the minimum depth indicator to ensure correct positioning).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Leblond with the indicator including a reposition indicator configured to indicate to preform repositioning as taught by Ganz in order be operated and utilized within a single hand of a practitioner ([0148] of Ganz).
Claim(s) 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Leblond, in view of DaCosta and Inoue, as applied to claim 3 above, and further in view of Kuzum et al. (US20170106204, hereafter “Kuzum”)
Regarding claim 16, Leblond substantially discloses all the limitations of the claimed invention, specifically, Leblond discloses wherein positioning the surgical instrument through the access hole and within the resection cavity ([0065], the biopsy device is inserted into the sample of biological tissue), but does not explicitly disclose where the disclose positioning within the resection cavity obscures at least a portion of the field of view of the surgical microscope; and the obscured portion of the field of view includes shadowed tissue.
However, in the same field of endeavor, Kuzum teaches wherein
positioning the surgical instrument through the access hole and within the resection cavity obscures at least a portion of the field of view of the surgical microscope ([0065], FIGS. 9A-9C, the probe is inserted into the surgical cavity blocking/obscuring the field of view of the microscope); and
the obscured portion of the field of view includes shadowed tissue ([0065], FIGS. 9A-9C, as the probe is blocking the field of view of the microscope, shadows are generated over the tissue within the surgical cavity due to the presence of the probe in surgical cavity).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Leblond with the positioning of the surgical instrument through the access hole within the resection cavity obscures at least a portion of the field of view of the microscope and the obscured portion of the field of view includes shadowed tissue as taught by Kuzumin order to provide an implantable brain electrode that allows recording interactions between different cortex regions or interactions of cortex with other subcortical structures ([0033] of Kuzum).
Regarding claim 17, Leblond, in view of Kuzum, substantially discloses all the limitations of the claimed invention, specifically, Leblond discloses further comprising:
positioning the surgical instrument such that the surgical instrument is in contact with the tissue ([0065], [0067], FIGS. 3A-3C, the biopsy device is inserted into the sample of biological tissue);
collecting fluorescent emission from the tissue using the at least one optical fiber of the surgical instrument ([0065], [0067], FIG. 3A); and
controlling the indicator of the tissue detection system based on the fluorescent emissions from the shadowed tissue as collected by the at least one optical fiber of the surgical instrument ([0023] the output device displays the indicative/indicator determined optical property collected by the at least one optical fiber of the surgical instrument), and specifically Kuzum discloses the shadowed tissue ([0065], FIGS. 9A-9C).
Regarding claim 18, Leblond, in view of Kuzum, substantially discloses all the limitations of the claimed invention, specifically, Leblond discloses further comprising:
the optical fiber which provides the excitation light (see [0023]-[0026]),
controlling the indicator of the tissue detection system based on the fluorescent emissions from the tissue ([0026], [0075]-[0076], FIG. 13, the determined optical property being indicative of fluorescence occurring in the surrounding tissue displayed on the output device to a surgeon); and specifically,
Kuzum discloses positioning the surgical instrument such that at least a portion of the shadowed tissue is illuminated by the excitation light from the at least one optical fiber of the tissue detection system ([0065], FIGS. 9A-9C, as it is understood that the tissue shown in the effort mentioned referenced images is shadowed, the shadowing is the result of the light rather than directly being transmitted to the surface of the tissue, is instead transmitted/illuminating the surgical instrument, and such that the tissue is disclosed as being shadowed, and not completely blocked, therefore it is understood by one of skill in the art of optics, that at least a portion of the light being transmitted towards the surface of the tissue does illuminate the tissue, although potentially indirectly via the surface of the surgical instrument).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Leblond, in view of DaCosta, Inoue, and Kuzum, as applied to claim 16 above, and further in view of Mori (US3734593)
Regarding claim 19, Leblond, in view of Kuzum, substantially discloses all the limitations of the claimed invention, specifically, Kuzum discloses further comprising:
positioning the surgical instrument such that at least a portion of the shadowed tissue is illuminated by the excitation light from the at least one optical fiber of the tissue detection system ([0065], FIGS. 9A-9C, as it is understood that the tissue shown in the effort mentioned referenced images is shadowed, the shadowing is the result of the light rather than directly being transmitted to the surface of the tissue, is instead transmitted/illuminating the surgical instrument, and such that the tissue is disclosed as being shadowed, and not completely blocked, therefore it is understood by one of skill in the art of optics, that at least a portion of the light being transmitted towards the surface of the tissue does illuminate the tissue, although potentially indirectly via the surface of the surgical instrument); but is silent on
disabling the indicator of the tissue detection system to allow the surgeon to observe the fluorescent emissions from the shadowed tissue without interference from light emitted by the indicator.
However, in solving the same problem, Mori teaches disabling the indicator of the tissue detection system to allow the surgeon to observe the fluorescent emissions from the shadowed tissue without interference from light emitted by the indicator (column 4, lines 27-34, fig. 1, the indicator 16 can be turned off so that such light spot will not interfere with the observation of the portion used to identify any particular portion of the specimen by the user)
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Leblond with the step of disabling the indicator of the tissue detection system to allow the surgeon to observe the fluorescent emissions from the shadowed tissue without interference from light emitted by the indicator as taught by Mori order to provide a microscope with a light indicator which projections into the field of view of the microscope and the indicator is capable of being be disabled to not interfere with observation within the field of view the microscope (column 1, lines 46-60, column four, lines 33-34, of Mori).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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/A.S./Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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