DETAILED ACTION
Summary
Claims 1-20 are pending in the application. Claims 8-14 are rejected under 35 USC 112(b). Claims 1-20 are rejected under 35 USC 103. Claims 1-20 are rejected under non-statutory double patenting.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “thoracic 11” in [0045], “lumbar 2” in [0045], “sacral 2” in [0045] and “sacral 4” in [0045]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[0045] recites patent. It should recite “patient”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites “one or more processors, communicatively coupled to the one or more memories to: obtain imaging data… wherein a voltage sensitive dye is applied to stain nerve tissue associated with the one or more body parts of the patient, wherein the voltage sensitive dye is activated”. It is not clear if the one or more processors are configured to apply and activate the image sensitive dye, or just that the processors are configured to obtain image data which includes body parts that have been stained and then activated. Clarification is required. For the purposes of examination, the latter definition will be used.
All claims dependent from the above claims rejected under 35 USC 112(b) are also rejected, as the limitations of the dependent claims fail to cure the deficiencies identified above.
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.
Claims 1, 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth et al. (U.S PGPub 2018/0020921 A1) in view of Benzanilla et al. (WO 2015/095344 A1), Golijanin (U.S PGPub 2007/0122345 A1), and Wang et al. (U.S PGPub 2016/0242651 A1).
Regarding Claim 1, Deisseroth teaches a method (Abstract), comprising:
activating, by a surgical system that includes one or more devices (Fig. 7, 700) [0080], a voltage sensitive dye using neuromodulation [0009],
wherein activating the voltage sensitive dye causes a fluorescence [0089];
obtaining, by the surgical system (Fig. 7, 702), imaging data (Fig. 7, 704) regarding the tissue based the fluorescence [0009]+[0080];
causing, by the surgical system, the imaging data to be displayed [0081]
by the surgical system (Fig. 7, 702) and based on the voltage sensitive dye being activated using the neuromodulation [0080] ([0080] further details that the images are of action potentials).
Deisseroth is silent regarding wherein activation is performed based on the voltage sensitive dye binding to a cell membrane associated with tissue of a patient.
Benzanilla teaches methods of using voltage sensitive compositions (Abstract). These compositions can be activated by binding to cells membranes associated with tissue of a patient [0027] (if the cells are labeled to detect changes in the membrane, then the dye is bond to the cellular membrane).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Deisseroth so the voltage sensitive dye binds to the cellular membrane, as taught by Benzanilla, as this allows the system to diagnose abnormal electrical activity over a large region, with enough spatial resolution to localize anomalies to small areas, as recognized by Benzanilla [0005].
The combination fails to explicitly teach wherein the imaging data includes fluorescence images that depict the fluorescence caused by activating the voltage sensitive dye, and wherein the imaging data identifies a nerve map of at least one of: one or more nerve bundles associated with the tissue of the patient, or one or more nerve branches associated with the tissue of the patient.
Golijanin teaches a system for determining the location of nerves (Abstract). The system is used to identify nerve tissue associated with a prostate of the patient [0020]. This system uses fluorescent images to identify nerve bundles [0011]. The system identifies a nerve map of at least one of: one or more nerve bundles associated with the prostate [0051] and one or more nerve branches associated with the prostate [0035]. The images of the nerves are then displayed on a display [0011].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination of references to target the spinal cord in order to activate nerves associated with the prostate, as taught by Golijanin, because this improves the mapping of nerve, making sparing the nerves during prostate surgery easier, as recognized by Golijanin [0010]. One of ordinary skill would recognize that, in the combination, the displayed imaging data of Deisseroth would be the nerve map of Golijanin.
The combination fails to explicitly teach imaging data of the photoacoustic effect, activating the dye causes a photoacoustic effect, or teach wherein the imaging data includes photoacoustic image that are based on the photoacoustic effect caused by activating the voltage sensitive dye.
Wang teaches a system for photoacoustic images of action potentials (Abstract). This system images voltage sensitive dye which was activated (Fig. 19, 1004) [0038]. The activated dye causes fluorescence and the photoacoustic effect [0055]-[0056]. The voltage sensitive dye produces photoacoustic signals, which are detected to produce the image (Fig. 19, 1006) [0039]+[0041].
It would have been obvious to one of ordinary skill in the before the effective filing date to modify the combined system to have imaging data based on the photoacoustic affect, as taught by Wang, because this allows for higher resolution imaging of the nerves of a subject, as recognized by Wang [0006]. One of ordinary skill would recognize that, in the combination, the imaging data used to determine the nerve map would further include the photoacoustic signals as taught by Wang.
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Deisseroth further teaches wherein activating the voltage sensitive dye comprises: activating the voltage sensitive dye in a manner that causes a variation to be identifiable by the imaging data [0162].
Deisseroth fails to explicitly teach the variation is a voltage membrane variation.
Benzanilla teaches that the voltage sensitive dye changes based on membrane voltage variations [0006], which can be reviewed on a display [0081].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Deisseroth so the voltage sensitive dye has a detectable voltage membrane variation, as taught by Benzanilla, as this allows the system to diagnose abnormal electrical activity over a large region, with enough spatial resolution to localize anomalies to small areas, as recognized by Benzanilla [0005].
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Deisseroth further teaches wherein obtaining the imaging data comprises: obtaining the imaging data using a camera (Fig. 7, 702) [0080] that is capable of capturing fluorescent light [0174],
wherein the imaging data identifies fluorescence contrast associated with the voltage sensitive dye being activated using neuromodulation [0099] (ΔF/F is fluorescence [0174]).
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Deisseroth further teaches wherein activating the voltage sensitive dye comprises: activating the voltage sensitive dye using the neuromodulation to cause the fluorescence [0079]-[0080]+[0089].
Deisseroth fails to explicitly teach emitting a pulse laser light at nerve tissue associated with the fluorescence to cause thermal elastic expansion of the tissue; capturing sound waves caused by the thermal elastic expansion of the tissue; converting the sound waves into electrical signals; and converting the electrical signals into data corresponding to the photoacoustic images.
Wang further teaches a pulse laser light [0042] at nerve tissue associated with the fluorescence to cause thermal elastic expansion of the tissue (Fig. 19, 1004) [0038]; capturing sound waves caused by the thermal elastic expansion of the tissue [0039] (the photoacoustic signals are sound waves); converting the sound waves into electrical signals [0066] (the ultrasound transducer convert ultrasound waves to electrical waves that can be analyzed by the computer [0063]+[0080]) ; and converting the electrical signals into data corresponding to the photoacoustic images [0047]+[0066].
It would have been obvious to one of ordinary skill in the before the effective filing date to modify the combined system to have imaging data based on the photoacoustic affect, as taught by Wang, because this allows for higher resolution imaging of the nerves of a subject, as recognized by Wang [0006].
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Deisseroth teaches activating the voltage sensitive dye comprises: activating the voltage sensitive dye using ultrasound neuromodulation by causing ultrasound energy [0079].
The Deisseroth fails to explicitly teach wherein the tissue is nerve tissue associated with a prostate of the patient; and wherein activating the voltage sensitive dye comprises: activating the voltage sensitive dye using ultrasound neuromodulation by causing ultrasound energy to be directed toward a spinal cord of the patient to cause the voltage sensitive dye to be activated on the nerve tissue associated with the prostate of the patient.
Golijanin teaches a system for determining the location of nerves (Abstract). The system is used to identify nerve tissue associated with a prostate of the patient [0020]. Stimulation can be directed toward a spinal cord of the patient to cause the voltage sensitive dye to be activated on the nerve tissue associated with the prostate of the patient [0034]-[0035].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination of references to target the spinal cord in order to activate nerves associated with the prostate, as taught by Golijanin, because this improves the mapping of nerve, making sparing the nerves during prostate surgery easier, as recognized by Golijanin [0010].
Regarding Claim 7, the combination of references teaches the invention substantially as claimed. Deisseroth further teaches wherein the neuromodulation includes at least one of: ultrasound neuromodulation, neuromodulation using thermal energy, or neuromodulation using electrical current excitations [0079].
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth in view of Benzanilla, Golijanin, and Wang as applied to claim 1 above, and further in view of Gibbs et al. (U.S PGPub 2021/0236657 A1).
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. The combination fails to explicitly teach flushing, by the surgical system, a first portion of the voltage sensitive dye, wherein a second portion of the voltage sensitive dye that is bound to the cell membrane associated with the tissue is not flushed; and wherein activating the voltage sensitive dye comprises: activating the second portion of the voltage sensitive dye.
Gibbs teaches fluorophores for use during surgery for nerve preservation (Abstract). The system flushes, by the surgical system, a first portion of the voltage sensitive dye [0427], wherein a second portion of the voltage sensitive dye that is bound to the tissue is not flushed [0427]; and wherein activating the voltage sensitive dye comprises: activating the second portion of the voltage sensitive dye [0427].
It would have been obvious to one of ordinary skill in the art to flush the dye after staining, as taught by Gibbs, because this increases the signal to background ratio of the nerve, as recognized by Gibbs [0427].
Claims 8-9, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth in view of Wang.
Regarding Claim 8, Deisseroth teaches a device, comprising: one or more memories [0012]; and
one or more processors, communicatively coupled to the one or more memories, [0012] to:
obtain imaging data (Fig. 7, 704) [0080],
wherein the imaging data that is obtained depicts one or more body parts of a patient [0011],
wherein a voltage sensitive dye is applied to stain nerve tissue associated with the one or more body parts of the patient [0080],
wherein the voltage sensitive dye is activated [0079],
wherein a first portion of the imaging data includes fluorescence images capturing a fluorescence of the nerve tissue [0174]+[0183] based on the voltage sensitive dye being activated by the ultrasound neuromodulation [0079]-[0080]; and provide the imaging data for display [0081]
The combination fails to explicitly teach a second portion of the imaging data includes photoacoustic images that are based on a photoacoustic effect caused by activating the voltage sensitive dye.
Wang teaches a system for photoacoustic images of action potentials (Abstract). This system images voltage sensitive dye which was activated (Fig. 19, 1004) [0038]. The activated dye causes fluorescence and the photoacoustic effect [0055]-[0056]. The voltage sensitive dye produces photoacoustic signals, which are detected to produce the image (Fig. 19, 1006) [0039]+[0041].
It would have been obvious to one of ordinary skill in the before the effective filing date to modify the combined system to have imaging data based on the photoacoustic affect, as taught by Wang, because this allows for higher resolution imaging of the nerves of a subject, as recognized by Wang [0006]. One of ordinary skill would recognize that, in the combination, the imaging data used to determine the nerve map would further include the photoacoustic signals as taught by Wang.
Regarding Claim 9, the combination cation teaches invention substantially as claims. Deisseroth further teaches the voltage sensitive dye is activated by the ultrasound neuromodulation [0079]
Regarding Claim 14, Deisseroth teaches the invention as claimed. Deisseroth further teaches wherein the one or more processors [0012] are further to monitor the one or more body parts using the imaging data [0080]-[0081].
Deisseroth fails to explicitly teach monitor the one or more body parts of the patient using a photoacoustic imaging technique.
Wang teaches monitor the one or more body parts of the patient using a photoacoustic imaging technique [0025].
It would have been obvious to one of ordinary skill in the before the effective filing date to modify the system of Deisseroth to further monitor the body part using imaging data based on the photoacoustic affect, as taught by Wang, because this allows for higher resolution imaging of the nerves of a subject, as recognized by Wang [0006].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth in view of Wang as applied to claim 8 above, and further in view of Golijanin and Jeong (U.S PGPub 2019/0254545 A1).
Regarding Claim 10, Deisseroth teaches the invention substantially as claimed. Deisseroth further teaches wherein the one or more processors [0012] are further to:
the surgical system to apply the voltage sensitive dye to stain the nerve tissue [0080]; and
the surgical system to activate the voltage sensitive dye [0080],
wherein activating the voltage sensitive dye stimulates the nerve tissue [0079]-[0080]; and
wherein the one or more processors [0012], when obtaining the imaging data, are to: communicate with the surgical system to cause the surgical system to capture (Fig. 7, 702) [0080] and provide the imaging data [0081].
Deisseroth fails to explicitly teach wherein the one or more body parts include a prostate of the patient, and a surgical system that includes one or more devices, to cause the surgical system to perform an incision to provide access to the prostate of the patient.
Golijanin teaches a system for determining the location of nerves (Abstract). The system is used to identify nerve tissue associated with a prostate of the patient [0020]. The surgical system performs an incision in order to obtain access to the prostate [0057].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination of references to target the spinal cord in order to activate nerves associated with the prostate, as taught by Golijanin, because this improves the mapping of nerve, making sparing the nerves during prostate surgery easier, as recognized by Golijanin [0010].
The combination is silent on the processor communicating with the surgical system to perform the incision, stain the dye, and perform ultrasound.
Jeong teaches a system for mapping the nerves during a surgery (Abstract). This surgery can be performed robotically (which means a processor communicates to the different surgical system to perform the steps) (Fig. 2, 240) [0030].
It would have been obvious to one of ordinary skill in the art to have a processor communicate with the surgical system, as taught by Jeong, as the substitution for one known method of performing a surgery with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of performing the surgery robotically are reasonably predictable.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth in view of Wang as applied to claim 8 above, and further in view of Gibbs.
Regarding Claim 11, Deisseroth teaches the invention substantially as claimed. Deisseroth further teaches wherein the one or more processors [0012] and a second portion of the voltage sensitive dye is capable of excitation via a performance of the ultrasound neuromodulation [0079]-[0080].
Deisseroth fails to explicitly teach wherein the one or more body parts include a prostate of the patient; and communicate with a surgical system that includes one or more devices to cause the surgical system to flush a first portion of the voltage sensitive dye, wherein the first portion of the voltage sensitive dye is not bound to the nerve tissue, and wherein a second portion of the voltage sensitive dye is bound to the nerve tissue.
Gibbs teaches fluorophores for use during surgery for nerve preservation (Abstract). The system flushing, by the surgical system, a first portion of the voltage sensitive dye [0427], wherein a second portion of the voltage sensitive dye that is bound to the tissue is not flushed [0427]; and wherein activating the voltage sensitive dye comprises: activating the second portion of the voltage sensitive dye [0427]. This staining/flushing can be done during a robotic surgery [0428] (which means a processor communicates to the different surgical system to perform the steps).
It would have been obvious to one of ordinary skill in the art to flush the dye after staining, as taught by Gibbs, because this increases the signal to background ratio of the nerve, as recognized by Gibbs [0427].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth in view of Wang as applied to claim 8 above, and further in view of Scott et al. (U.S PGPub 2009/0270678 A1).
Regarding Claim 12, Deisseroth teaches the invention substantially as claimed. Deisseroth fails to explicitly teach wherein the one or more body parts include a prostate of the patient; and wherein the one or more processors are further to: provide, for display, information identifying a visible light image of the prostate of the patient; and overlay the visible light image of the prostate of the patient with the first portion of the imaging data.
Scott teaches a system which combines visible light and fluorescence images (Abstract). This system images the prostate [0183]. It prepares an image for the display by combining a visible light image of the prostate [0143], a with imaging data identifying the fluorescence of the nerve tissue associated with the prostate [0143]+[0183]+[0361].
It would have been obvious to one of ordinary skill in the art before the effective filing date the system of Deisseroth to combine visible light and fluorescent images, as taught by Scott, because this enhances the precision of removing diseased tissue while avoiding adjacent nerve, thereby improving the morbidity of the procedure, as recognized by Scott [0361].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth and Wang as applied to claim 8 above, and further in view of Wang et al. (U.S PGPub 2008/0123083 A1) (Wang’083).
Regarding Claim 13, Deisseroth teaches the invention as claimed. Deisseroth further teaches wherein the one or more processors [0012] are further to generate a visualization of the nerve tissue based on the fluorescence images [0009] (Fig. 7, 706) [0080]-[0081]; and wherein the one or more processors when proving the image data for display are to: provide the visualization of the nerve tissue for display [0081].
Deisseroth fails to explicitly teach the visualization including photoacoustic images .
Wang’083 teaches a system for imaging the patient (Abstract). This system uses both photoacoustic images and fluorescent images for display [0032].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to create a visualization using both fluorescent and photoacoustic images, as taught by Wang’083, because this allows for a more accurate visualization of the body morphology, as recognized by Wang’’083 [0032].
Claims 15 and 17-20 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth in view of Golijanin, Jeong, and Wang.
Regarding Claim 15, Deisseroth teaches
communicating, by the device and with the surgical system (Fig. 7, 700) [0080], to cause the surgical system to activate, using ultrasound neuromodulation [0079], at least a portion of a voltage sensitive dye [0009],
wherein activating the at least the portion of the voltage sensitive dye causes a fluorescence associated with at least a portion of the nerve tissue [0174];
communicating, by the device and with the surgical system (Fig. 7, 700) [0080], to cause the surgical system to obtain imaging data (Fig. 7, 704) [0080]-[0081]
wherein the imaging data includes fluorescence imaging data of the fluorescence [0174] associated with the at least the portion of the nerve tissue [0080],
wherein the imaging data identifies a nerve map [0164] of at least one of:
providing, by the device, the imaging data for display [0081].
Deisseroth fails to explicitly teach by a device and with a surgical system, to cause the surgical system to perform one or more incisions into a patient, wherein the voltage sensitive dye has been applied to nerve tissue associated with a prostate of the patient, and the nerve map is at least one of: one or more nerve bundles associated with the prostate of the patient, or one or more nerve branches associated with the prostate of the patient; and to allow a prostatectomy to be performed in a manner that uses the nerve map to avoid disturbance of the nerve tissue.
Golijanin teaches a system for determining the location of nerves (Abstract). The system is used to identify nerve tissue associated with a prostate of the patient [0020]. The surgical system performs an incision in order to obtain access to the prostate [0057]. The system images on one or more nerve bundles associated with the prostate [0051] and one or more nerve branches associated with the prostate [0035]
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination of references to target the spinal cord in order to activate nerves associated with the prostate, as taught by Golijanin, because this improves the mapping of nerve, making sparing the nerves during prostate surgery easier, as recognized by Golijanin [0010].
The combination is silent on the processor communicating with the surgical system to perform the incision, activating the dye, and to obtain imaging data.
Jeong teaches a system for mapping the nerves during a surgery (Abstract). This surgery can be performed robotically (which means a processor communicates to the different surgical system to perform the steps) (Fig. 2, 240) [0030].
It would have been obvious to one of ordinary skill in the art to have a processor communicate with the surgical system, as taught by Jeong, as the substitution for one known method of performing a surgery with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of performing the surgery robotically are reasonably predictable.
The combination fails to explicitly teach the voltage sensitive dye causing the photoacoustic effect or photoacoustic imaging data based on the photoacoustic effect caused by activating the voltage sensitive dye.
Wang teaches a system for photoacoustic images of action potentials (Abstract). This system images voltage sensitive dye which was activated (Fig. 19, 1004) [0038]. The activated dye causes fluorescence and the photoacoustic effect [0055]-[0056]. The voltage sensitive dye produces photoacoustic signals, which are detected to produce the image (Fig. 19, 1006) [0039]+[0041].
It would have been obvious to one of ordinary skill in the before the effective filing date to modify the combined system to have imaging data based on the photoacoustic affect, as taught by Wang, because this allows for higher resolution imaging of the nerves of a subject, as recognized by Wang [0006]. One of ordinary skill would recognize that, in the combination, the imaging data used to determine the nerve map would further include the photoacoustic signals as taught by Wang.
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. Deisseroth further teaches the voltage sensitive dye being activated by the ultrasound neuromodulation [0079]
Deisseroth fails to explicitly teach wherein communicating with the surgical system to cause the surgical system to activate the voltage sensitive dye comprises: providing a set of instructions to the surgical system to cause the surgical system to activate the voltage sensitive dye in a manner that causes a photoacoustic effect.
Wang teaches a system for photoacoustic images of action potentials (Abstract). This system images voltage sensitive dye which was activated (Fig. 19, 1004) [0038]. The voltage sensitive dye produces photoacoustic signals, which are detected to produce the image (Fig. 19, 1006) [0039]+[0041].
It would have been obvious to one of ordinary skill in the before the effective filing date to modify the system of Deisseroth to have imaging data based on the photoacoustic affect, as taught by Wang, because this allows for higher resolution imaging of the nerves of a subject, as recognized by Wang [0006].
Regarding Claim 18, the combination of references teaches the invention substantially as claimed. Deisseroth further teaches wherein communicating with the surgical system to cause the surgical system to obtain the imaging data of the fluorescence associated with the nerve tissue comprises: providing a set of instructions [0012] to the surgical system to cause the surgical system to obtain the imaging data (Fig. 7, 704) [0080], wherein the nerve map [0164], that is identified by the imaging data (Fig. 7, 704) [0080], depicts the nerve tissue in a manner that allows a function or a status of one or more nerves, that are part of the nerve tissue, to be identified [0070]+[0075].
Regarding Claim 19, the combination of references teaches the invention substantially as claimed. Deisseroth further teaches wherein communicating with the surgical system to cause the surgical system to activate the at least the portion of the voltage sensitive dye [0009] comprises: applying ultrasound energy [0079].
Deisseroth fails to explicitly teach the energy applied by at least one of non-invasive stimulation though a spinal cord of the patient, laparoscopic stimulation at a surgical site of the patient, or transrectal stimulation via a rectum of the patient.
Golijanin further teaches laparoscopic stimulation at a surgical site of the patient [0011]
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combination of references laparoscopically stimulate the nerves at the surgical site, as taught by Golijanin, as the substitution for one known one known method for stimulation with another yields predictable results to one of ordinary skill in the art. One of ordinary skill would have been able to carry out such a substitution, and the results of laparoscopically stimulating the nerves are reasonably predictable.
Regarding Claim 20, Deisseroth teaches the invention as claimed. Deisseroth further teaches communication, by the device and with the surgical system [0012], to cause the surgical system to monitor the one or more body parts using the imaging data [0080]-[0081].
Deisseroth fails to explicitly teach monitor the one or more body parts of the patient using a photoacoustic imaging technique.
Wang teaches monitor the one or more body parts of the patient using a photoacoustic imaging technique [0025].
It would have been obvious to one of ordinary skill in the before the effective filing date to modify the system of Deisseroth to further monitor the body part using imaging data based on the photoacoustic affect, as taught by Wang, because this allows for higher resolution imaging of the nerves of a subject, as recognized by Wang [0006].
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Deisseroth in view of Golijanin, Jeong, and Wang as applied to claim 15 above, and further in view of Gibbs.
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. Deisseroth further teaches wherein the at least the portion of the voltage sensitive dye is a first portion [0009]. The system communicates, with the device and with the surgical system, causes the surgical system to stain a surface of the tissue of the patient using the voltage sensitive dye [0080].
Deisseroth fails to explicitly teach the tissue is a prostate, wherein the staining is performed for a period of time; and communicating, by the device and with the surgical system, to cause the surgical system to flush a second portion of the voltage sensitive dye from the patient after an expiration of the period of time, wherein the first portion of the voltage sensitive dye remains bound at a cell membrane level to the nerve tissue associated with the prostate of the patient.
Gibbs teaches fluorophores for use during surgery for nerve preservation (Abstract). The system stains the prostate [0005] for a threshold period of time [0397]. The system flushes, by the surgical system, a second portion of the voltage sensitive dye [0427], after the threshold period of time [0397]. The first portion of the voltage sensitive dye remains bound at the cell membrane level to the nerve tissue [0148]+[0427]. This staining/flushing can be done during a robotic surgery [0428] (which means a processor communicates to the different surgical system to perform the steps).
It would have been obvious to one of ordinary skill in the art to modify the system of Deisseroth to flush the dye after staining, as taught by Gibbs, because this increases the signal to background ratio of the nerve, as recognized by Gibbs [0427].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 12,274,530 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons set forth below.
Regarding Claim 1, the Patent teaches a method (Claim 1, Col 21, line 15), comprising:
activating, by a surgical system that includes one or more devices, a voltage sensitive dye using neuromodulation (Claim 1, Col 21, lines 16-18),
wherein the voltage sensitive dye is activated based on the voltage sensitive dye binding to a cell membrane associated with a tissue of a patient (Claim 1, Col 21, lines 19-21), and
wherein activating the voltage sensitive dye causes a fluorescence and a photoacoustic effect (Claim 1, Col 21, lines 22-23);
obtaining, by the surgical system, imaging data regarding the tissue based on the fluorescence and the photoacoustic effect (Claim 1, Col 21, lines 24-26),
wherein the imaging data includes fluorescence images that depict the fluorescence and photoacoustic images that are based on the photoacoustic effect caused by activating the voltage sensitive dye (Claim 1, Col 21, lines 27-30), and
wherein the imaging data identifies a nerve map of at least one of: (Claim 1, Col 21, lines 31-32)
one or more nerve bundles associated with the tissue of the patient, or one or more nerve branches associated with the tissue of the patient (Claim 1, Col 21, lines 33-36);
and causing, by the surgical system, the nerve map to be displayed (Claim 1, Col 21, lines 37-38).
Regarding Claim 2, the Patent teaches the invention as claimed. The Patent further teaches flushing, by the surgical system, a first portion of the voltage sensitive dye, wherein a second portion of the voltage sensitive dye that is bound to the cell membrane associated with the tissue is not flushed; and wherein activating the voltage sensitive dye comprises: activating the second portion of the voltage sensitive dye (Claim 2).
Regarding Claim 3, the Patent teaches the invention as claimed. The Patent further teaches wherein activating the voltage sensitive dye comprises: activating the voltage sensitive dye in a manner that causes a voltage membrane variation to be identifiable by the imaging data (Claim 3).
Regarding Claim 4, the Patent teaches the invention as claimed. The Patent further teaches wherein obtaining the imaging data comprises: obtaining the imaging data using a camera that is capable of capturing fluorescent light, wherein the imaging data identifies the fluorescence associated with the voltage sensitive dye being activated using the neuromodulation (Claim 4).
Regarding Claim 5, the Patent teaches the invention as claimed. The Patent further teaches wherein activating the voltage sensitive dye comprises: activating the voltage sensitive dye using the neuromodulation to cause the fluorescence; emitting a pulse laser light at nerve tissue associated with the fluorescence to cause thermal elastic expansion of the tissue; capturing sound waves caused by the thermal elastic expansion of the tissue; converting the sound waves into electrical signals; and converting the electrical signals into data corresponding to the photoacoustic images (Claim 5).
Regarding Claim 6, the Patent teaches the invention as claimed. The Patent further teaches wherein the tissue is nerve tissue associated with a prostate of the patient; and wherein activating the voltage sensitive dye comprises: activating the voltage sensitive dye using ultrasound neuromodulation by causing ultrasound energy to be directed toward a spinal cord of the patient to cause the voltage sensitive dye to be activated on the nerve tissue associated with the prostate of the patient (Claim 6).
Regarding Claim 7, the Patent teaches the invention as claimed. The Patent further teaches wherein the neuromodulation includes at least one of: ultrasound neuromodulation, neuromodulation using thermal energy, or neuromodulation using electrical current excitations (Claim 7).
Regarding Claim 8, the Patent teaches a device (Claim 8, Col 22, line 32), comprising:
one or more memories (Claim 8, Col 22, line 33); and
one or more processors, communicatively coupled to the one or more memories (Claim 8, Col 22, lines 34-35), to:
obtain imaging data (Claim 8, Col 22, line 36),
wherein the imaging data that is obtained depicts one or more body parts of a patient (Claim 8, Col 22, lines 37-38),
wherein a voltage sensitive dye is applied to stain nerve tissue associated with the one or more body parts of the patient (Claim 8, Col 22, lines 39-41),
wherein the voltage sensitive dye is activated (Claim 8, Col 22, line 42),
wherein a first portion of the imaging data includes fluorescence images capturing a fluorescence of the nerve tissue based on the voltage sensitive dye being activated (Claim 8, Col 22, lines 43-46), and
wherein a second portion of the imaging data includes photoacoustic images that are based on a photoacoustic effect caused by activating the voltage sensitive dye Claim 8, Col 22, lines 47-50); and
provide the imaging data for display (Claim 8, Col 22, line 51).
Regarding Claim 9, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein the voltage sensitive dye is activated by ultrasound neuromodulation (Claim 9).
Regarding Claim 10, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein the one or more body parts include a prostate of the patient; and wherein the one or more processors are further to: communicate with a surgical system that includes one or more devices, to cause the surgical system to perform an incision to provide access to the prostate of the patient; communicate with the surgical system to cause the surgical system to apply the voltage sensitive dye to stain the nerve tissue; and communicate with the surgical system to cause the surgical system to activate the voltage sensitive dye, wherein activating the voltage sensitive dye stimulates the nerve tissue; and wherein the one or more processors, when obtaining the imaging data, are to: communicate with the surgical system to cause the surgical system to capture and provide the imaging data (Claim 10).
Regarding Claim 11, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein the one or more body parts include a prostate of the patient; and wherein the one or more processors are further to: communicate with a surgical system that includes one or more devices to cause the surgical system to flush a first portion of the voltage sensitive dye, wherein the first portion of the voltage sensitive dye is not bound to the nerve tissue, and wherein a second portion of the voltage sensitive dye is bound to the nerve tissue and is capable of excitation via a performance of ultrasound neuromodulation (Claim 11).
Regarding Claim 12, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein the one or more body parts include a prostate of the patient; and wherein the one or more processors are further to: provide, for display, information identifying a visible light image of the prostate of the patient; and overlay the visible light image of the prostate of the patient with the first portion of the imaging data (Claim 12).
Regarding Claim 13, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein the one or more processors are further to: generate a visualization of the nerve tissue based on the fluorescence images and the photoacoustic images; and wherein the one or more processors, when providing the imaging data for display, are to: provide the visualization of the nerve tissue for display (Claim 13).
Regarding Claim 14, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein the one or more processors are further to: monitor the one or more body parts of the patient using the imaging data (Claim 14).
Regarding Claim 15, the Patent teaches a method (Claim 15, Col 23, line 57), comprising:
communicating, by a device and with a surgical system, to cause the surgical system to perform one or more incisions into a patient (Claim 15, Col 23, lines 58-60);
communicating, by the device and with the surgical system, to cause the surgical system to activate, using ultrasound neuromodulation, at least a portion of a voltage sensitive dye (Claim 15, Col 23, lines 61-64),
wherein the voltage sensitive dye has been applied to nerve tissue associated with a prostate of the patient (Claim 15, Col 23, lines 64-67), and
wherein activating the at least the portion of the voltage sensitive dye causes a fluorescence associated with at least a portion of the nerve tissue and a photoacoustic effect (Claim 15, Col 24, lines 1-4);
communicating, by the device and with the surgical system, to cause the surgical system to obtain imaging data (Claim 15, Col 24, lines 5-7),
wherein the imaging data includes fluorescence imaging data of the fluorescence associated with the at least the portion of the nerve tissue and photoacoustic imaging data based on the photoacoustic effect caused by activating the voltage sensitive dye (Claim 15, Col 24, lines 8-12), and
wherein the imaging data identifies a nerve map of at least one of: (Claim 15, Col 24, lines 14-15)
one or more nerve bundles associated with the prostate of the patient, or one or more nerve branches associated with the prostate of the patient (Claim 15, Col 24, lines 16-19); and
providing, by the device, the nerve map for display, to allow a prostatectomy to be performed in a manner that uses the nerve map to avoid disturbance of the nerve tissue (Claim 15, Col 24, lines 20-23).
Regarding Claim 16, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein the at least the portion of the voltage sensitive dye is a first portion; wherein the method further comprises :communicating, by the device and with the surgical system, to cause the surgical system to stain a surface of the prostate of the patient using the voltage sensitive dye, wherein the staining is performed for a period of time; and communicating, by the device and with the surgical system, to cause the surgical system to flush a second portion of the voltage sensitive dye from the patient after an expiration of the period of time, wherein the first portion of the voltage sensitive dye remains bound at a cell membrane level to the nerve tissue associated with the prostate of the patient (Claim 16).
Regarding Claim 17, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein communicating with the surgical system to cause the surgical system to activate the voltage sensitive dye comprises: providing a set of instructions to the surgical system to cause the surgical system to activate the voltage sensitive dye, using the ultrasound neuromodulation, in a manner that causes the photoacoustic effect (Claim 17).
Regarding Claim 18, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein communicating with the surgical system to cause the surgical system to obtain the imaging data of the fluorescence associated with the nerve tissue comprises: providing a set of instructions to the surgical system to cause the surgical system to obtain the imaging data, wherein the nerve map, that is identified by the imaging data, depicts the nerve tissue in a manner that allows a function and a status of a nerve, that is part of the nerve tissue, to be identified (Claim 18).
Regarding Claim 19, the Patent teaches the invention substantially as claimed. The Patent further teaches wherein communicating with the surgical system to cause the surgical system to activate the at least the portion of the voltage sensitive dye comprises: applying ultrasound energy using at least one of: non-invasive stimulation through a spinal cord of the patient, laparoscopic stimulation at a surgical site of the patient, or transrectal stimulation via a rectum of the patient (Claim 19).
Regarding Claim 20, the Patent teaches the invention substantially as claimed. The Patent further teaches communicating, by the device and with the surgical system, to cause the surgical system to monitor one or more body parts of the patient using the imaging data (Claim 20).
Conclusion
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/SEAN D MATTSON/Primary Examiner, Art Unit 3798