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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/02/2025 has been entered.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. DE10 2020 102 012.0, filed on January 28, 2020.
Status of Claims
This Office Action is responsive to the claims filed on 05/27/2025. Claims 1, 3, 4, 6, 8-10, 12, 14 and 15 have been amended. Claim 2 was previously canceled. Claims 1 and 3-15 are presently pending in this application.
Claim Objections
Claims 1, 14 and 15 are objected to because of the following informalities: “a second 3-D reconstruction during the medium is introduced” should be amended to read “a second 3-D reconstruction during which the medium is introduced” or similar language to improve clarity.
Appropriate correction is required.
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.
Claims 1, 4, 5, 7, 10, 11, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava (US 20160106583) in view of Larin (WO 2017035328 A1) and Milner (US 20180228552).
Regarding claims 1, 14, and 15, Srivastava teaches an arrangement (Paragraphs [0004] and [0013]; a system is provided for image-guided delivery of therapeutics to an eye, system 10, Fig. 1);
a method (Paragraphs [0005] and [0012]; a method is provided for image-guided delivery of therapeutics to an eye, system 10, Fig. 1) comprising scanning (Paragraph [0014]; OCT scanner 12; Paragraph [0018]; OCT interface 52 can instruct the scanner to use specific scanning protocols), with an OCT device (Paragraph [0014]; optical coherence tomography (OCT) imager 12, Fig. 1), an object region volume in an object region (Paragraph [0014]; least one OCT image of the eye) by an OCT scanning beam (Paragraph [0014]; scanner to use specific scanning protocols);
and a non-transitory computer-readable storage medium (Paragraph [0031]; additional memory devices 208 and 210, such as a hard disk drive, server, stand alone database, or other non-volatile memory) storing a computer program (Paragraph [0017]; system control 50 is implemented as software instructions) that, when executed by a computer (Paragraph [0030]; the system 200 can be a personal computer, a laptop computer, a workstation, a computer system), causes the computer to perform the method;
the arrangement comprising:
an optical coherence tomography (OCT) device (Paragraph [0014]; optical coherence tomography (OCT) imager 12, Fig. 1) configured to generate OCT scanning information (Paragraph [0014]; configured to produce at least one OCT image of the eye) by scanning an object region volume in an object region (Paragraph [0014]; least one OCT image of the eye) with an OCT scanning beam (Paragraph [0014]; OCT scanner 12; Paragraph [0018]; OCT interface 52 can instruct the scanner to use specific scanning protocols);
a surgical instrument (Paragraph [0014]; therapeutic delivery system 14 includes a syringe with an injection tip, Fig. 1) that has a section that is arrangeable in the object region volume (Paragraph [0014]; configured to deliver the therapeutic to the eye through a distal end of a delivery mechanism) and is localizable there by the OCT device (Paragraph [0015]; system control 16 is configured to determine a position of the distal end of the delivery mechanism and control the therapeutic delivery system 14… system control 16 can be… part of either of the OCT scanner), the surgical instrument comprising a capillary with an opening (Paragraph [0024]; FIG. 3A shows a needle tip 72) for releasing a medium (Paragraph [0024]; injection of the therapeutic); and
a computer unit (Paragraph [0017]; system control 50… implemented as a stand-alone general purpose computer) connected to the OCT device (Paragraph [0018]; system control 50 includes an optical coherence tomography (OCT) interface 52) and configured to execute a computer program (Paragraph [0017]; implemented as software instructions) to:
determine one or more three-dimensional (3-D) reconstructions of the object region based on data from the OCT scanning information (Paragraph [0018]; OCT images can be provided in any form suitable for analysis, with examples including volumetric images), sensor data associated with a position of the section of the surgical instrument (Paragraph [0016]; position of instrument tips may be identified using en face OCT shadowing, cross-sectional contrast, or instrument-tracked imaging methods to locate specific treatment positions, and specific tissue layers targeted for therapeutic delivery), and preoperatively determined data (Paragraph [0016]; specific tissue layers targeted for therapeutic delivery may be identified before surgery); and
determine a 3-D volume of the medium introduced into a target area within the object region volume (Paragraph [0020]; dosage tracking component 60 is configured to monitor the delivery of the therapeutic from the at least one OCT image… the volume analysis component 62 can include an edge recognition algorithm that determines a spatial extent of the delivered therapeutic within the image and calculates a volume from the spatial extent of the therapeutic).
Srivastava does not explicitly teach the one or more 3-D reconstructions include a first 3-D reconstruction before the medium is introduced into a target area within the object region volume and a second 3-D reconstruction during the medium is introduced into the target area;
determine a 3-D volume of the medium by determining a difference between the first 3-D reconstruction and the second 3-D reconstruction.
Larin, however, teaches an optical coherence tomography device (Paragraph [0006]; methods and systems for real time 3D visual feedback… to optimize the placement, volume, and choice of viscosity of skin manipulations such as dermal filler injections… using optical coherence tomography (OCT)) wherein one or more 3-D reconstructions (Paragraph [0010]; 3D reconstruction, before and after injection in local or all areas of the face) include a first 3-D reconstruction before the medium is introduced (Paragraph [0010]; utilizing a model-based reconstruction method, i.e. 3D reconstruction, before… injection) into a target area within the object region volume (Paragraph [0010]; skin manipulations such as cosmetic dermal filler injections… local or all areas of the face) and a second 3-D reconstruction during the medium is introduced into the target area (Paragraph [0010]; a model-based reconstruction method, i.e. 3D reconstruction… after injection… volumes and dermal filler injection qualities can be pre-determined before injection and visualized during and post injection in a real time fashion; visualization during injection in a real-time fashion is considered to read on the limitation as understood in its broadest reasonable interpretation).
determine a 3-D volume of the medium (Paragraph [0032]-[0033]; a volume was acquired to investigate the injection…; use of OCT as a visual feedback tool with micrometer resolution during dermal filler injections).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified 3-D reconstructions in the arrangement, method, and non-transitory computer-readable storage medium of Srivastava to have included a first 3-D reconstruction before the medium is introduced into a target area within the object region volume and a second 3-D reconstruction during the medium is introduced into the target area as taught by Larin because it would have been a useful tool for real-time feedback in determining the correct dosage of injection medium (Paragraph [0032]) and further allowed the use of OCT as a visual feedback tool with micrometer resolution during injections (Paragraph [0033]).
Together Srivastava and Larin does not explicitly teach determine a 3-D volume of the medium by determining a difference between the first 3-D reconstruction and the second 3-D reconstruction.
Milner, however, teaches an arrangement (Paragraph [0043]; FIG. 1a, the image-guided system and method 100) comprising:
an optical coherence tomography (OCT) device (Paragraph [0041]; In one embodiment, the image-guided system comprises a multi-lumen surgical probe) configured to generate OCT scanning information by scanning an object region volume in an object (Paragraph [0045]; The OCT image is computed using standard OCT processing techniques 130…; Paragraph [0081]; OCT provides three-dimensional imaging allowing volume visualization of articular cartilage; Paragraph [0101]-[0105]; Image processing and analysis of OCT scans were performed to create a thickness map for a region of cartilage) region with an OCT scanning beam;
a surgical instrument (Paragraph [0071]; Biomaterial/Cell deposition system 250… syringe and needle 252, 254; Fig. 2A) that has a section that is arrangeable in the object region volume and is localizable there by the OCT device (Paragraph [0072]; The syringe needle will be oriented so that the end will appear in the background, perpendicular to the fast-axis, and will end at the focal plane; using the OCT system 210 to first position the applicator tip 252), the surgical instrument comprising a capillary with an opening for releasing a medium (Paragraph [0071]; and a syringe needle to direct deposition of the mixed hydrogel); and
determining a 3-D volume of the medium (Paragraph [0096]; OCT image-guidance informs the user about the flow of the deposition into the incision. This feature was showcased using milk:water:gelatin (40:40:20) ratio solution and the heated solution was permitted to flow into the incision and solidify-all the while imaged by the OCT real-time; Fig. 6) by determining a difference between the first 3-D reconstruction and the second 3-D reconstruction (Paragraph [0121]; From the OCT image, precise location for ON and OFF regions were sent to the laser for each B-scan and the trigger pulse controlled the location of cut on the tissue. OCT imaging feedback helped confirm these cutting sites and enabled calculation of removed tissue volumes using the total number of voxels removed from the volumetric images).
The reference of Milner teaches determining a removed volume by determining the difference before and after an operation. One of ordinary skill in the art, however, would understand substituting calculating the removed voxels for introduced voxels for precision cell, biologics and drug deposition as described in at least paragraphs [0041], [0072], [0096], and Fig. 6.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Srivastava in view of Larin such that determining a 3-D volume of the medium includes determining a difference between the first 3-D reconstruction and the second 3-D reconstruction as taught by Milner because it would further allow precisely determining the injected material during the procedure which would aid in precision material deposition in tissue that is vital for efficacy and safety of OA laser treatment (Milner, Paragraph [0095]-[0098). Furthermore, specific target spots can be localized or analyzed through the OCT and patient specific stem cell-laden hydrogel can be injected in the sites of micro-well creation. The image guided system and method, performed in vivo, can largely limit functional tissue damage (Milner, Paragraph [0065]).
Regarding claim 4, together Srivastava, Larin, and Milner teach all of the limitations of claim 1 as noted above.
Srivastava further teaches the OCT device is configured for successive continuous scanning of the object region volume by means of the OCT scanning beam (Paragraph [0018]; the OCT interface 52 can instruct the scanner to use specific scanning protocols to image… in real-time, including variation of radial scans) and/or successive continuous scanning of a subset region of the object region volume containing the section of the surgical instrument by means of the OCT scanning beam (Paragraph [0016]; the position of instrument tips may be identified… as real-time triggers to control the therapeutic delivery system.);
and/or the computer unit is further configured to execute the computer program to perform successive continuous determination of the one or more 3-D reconstruction of the object region volume (Paragraph [0016]; intraoperative OCT cross-sectional B-scan or volumetric datasets… real-time volumetric segmentation can be used) and/or for successive continuous determination of the relative position of the section of the surgical instrument in the object region volume (Paragraph [0016]; If the instrument tip moves out of the subretinal space as a result of global motion or tremor, injection automatically stops);
and/or the computer unit is further configured to execute the computer program to determine a spatial target position for the item in the one or more 3-D reconstruction of the object region volume (Paragraph [0016]; to locate specific treatment positions);
and/or the arrangement further comprises a memory (Paragraph [0031]; a system memory 206, memory devices 208 and 210) storing data determined presurgery (Paragraph [0022]; the dosage tracking component 60 can be provided to a delivery control component 70… indicates that a desired dosage is achieved or exceeds a predetermined threshold value; The dosage is understood to be data determined presurgery as understood in its broadest reasonable interpretation);
and/or the computer unit is further configured to execute the computer program to determine target areas (Paragraph [0016]; to locate specific treatment positions; locating specific treatment positions is considered to read on the claimed limitation of determining target areas as understood in its broadest reasonable interpretation) and/or spatial target positions in data determined presurgery and/or target areas (Paragraph [0012]; a surgeon or clinician can target these therapeutics to the area of interest) and/or spatial target positions in the one or more 3-D reconstruction of the object region volume by virtue of the application of methods for segmenting tissue structures and/or tissue layers (Paragraph [0016]; real-time automated tissue segmentation algorithms can be applied to intraoperative OCT cross-sectional B-scan or volumetric datasets to guide automated drug delivery);
and/or the computer unit is further configured to execute the computer program to generate a first guide variable in the form of control signals for the surgical instrument (Paragraph [0016]; used as real-time triggers to control the therapeutic delivery system; subretinal tissue layer of interest is targeted and injection automatically begins as the tip of the needle arrives at the layer-of-interest on OCT B-scans; The triggers to control the delivery system is considered to read on the claimed limitation of a guide variable for the item as understood in its broadest reasonable interpretation);
and/or the computer unit is further configured to execute the computer program to determine as a second guide variable a spatial target position in the target area in the one or more 3-D reconstruction of the object region volume (Paragraph [0016]; guide automated drug delivery… locate specific treatment positions… to control the therapeutic delivery system; The location of the treatment position is considered to read on the spatial target position guide variable as understood in its broadest reasonable interpretation) taking account of characteristic features of the surgical instrument (Paragraph [0016]; instrument tip moves out of the subretinal space… injection automatically stops) and/or of the target area in the one or more 3-D reconstruction of the object region volume (Paragraph [0016]; instrument tip moves out of the subretinal space… injection automatically stops), and/or taking account of geometric relationships comprising offset information between these (Paragraph [0016]; automatically begins as the tip of the needle arrives at the layer-of-interest);
and/or determine a third guide variable for the item in relation to the target area (Paragraph [0015]; or visual feedback provided to the user when a desired location, such as a retinal layer of interest, is reached), and the arrangement further comprises a display (Paragraph [0031]; display 216, Fig. 5) for visualizing the relative position of the section of the item in the one or more 3-D reconstruction of the object region volume (Paragraph [0012]; resolution of the OCT allows for visualization both the target area as well as the instrument delivery system; Paragraph [0024]; Figs. 3A-D) and/or for visualizing data determined presurgery and/or for visualizing the third guide variable determined in relation to the target area (Paragraph [0015]; or visual feedback provided to the user when a desired location, such as a retinal layer of interest, is reached) and/or for visualizing variables derived from the third guide variable (Paragraph [0015]; Feedback can also be provided to stop the therapeutic delivery when a desired volume has been delivered);
and/or the computer unit is further configured to execute the computer program to generate acoustic, optical or haptic indication signals for the surgeon based on the third guide variable determined in relation to the target area and/or variables derived therefrom (Paragraph [0015]; system control 14 instructing haptic, audible, or visual feedback provided to the user when a desired location, such as a retinal layer of interest, is reached. Feedback can also be provided to stop the therapeutic delivery when a desired volume has been delivered);
and/or the computer unit is further configured to execute the computer program to determine a corrected one or more 3-D reconstruction of the object region volume (Paragraph [0016]; the position of instrument tips may be identified using en face OCT shadowing) by recognizing regions that are shadowed by the surgical instrument (Paragraph [0019]; For example, the instrument identification component 54 can utilized en face iOCT shadowing) and by specifying a compensation rule for the one or more 3-D reconstruction of the object region volume in relation to these regions (Paragraph [0019]; It will be appreciated that these boundaries can be used to determine an appropriate delivery depth for the therapeutic.);
and/or the computer unit is further configured to execute the computer program to scan the object region volume and/or the section of the surgical instrument using specific scanning patterns (Paragraph [0018]; specific scanning protocols to sparsely image the injection site for rapid measurements of injection volume in real-time, including variation of radial scans.).
Regarding claim 5, together Srivastava, Larin, and Milner teach all of the limitations of claim 1 as noted above.
Milner further teaches OCT angiography data of the object region volume are generated from the OCT scanning information obtained by means of the OCT device by scanning the object region volume (Paragraph [0051]-[0053]; OCT information can be used to record angiography images that provide a map of the vasculature in the tissue; High resolution volume OCT images can be added to this view as the surgeon acquires images intraoperatively with the smart laser probe; where OCT volume images are analyzed and features of surgical relevance (vascular geometry, tissue optical properties, or tissue composition (e.g., lipid vs. water))).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Srivastava in view of Larin and Milner to have generating OCT angiography data of the object region volume as further taught by Milner because Vascular geometry combined with optical attenuation can indicate regions of abnormal tissue such as a tumor and the OCT image information could be used with rapid control algorithms to minimize non-specific damage and need not be explicitly presented to the surgeon (Milner, Paragraphs [0051]-[0053]).
Regarding claim 7, together Srivastava, Larin, and Milner teaches all of the limitations of claim 1 as noted above.
Srivastava further teaches the computer unit is further configured to execute the computer program to (Paragraph [0013]-[0016]; completely automate the delivery of therapeutics; will further include actuators for automatically inserting and withdrawing the injection tip into the eye; The use of fully automated delivery system is understood to have path planning steps as understood in its broadest reasonable interpretation) on the basis of a criterion (Paragraph [0016]; the position of instrument tips may be identified; specific tissue layers targeted for therapeutic delivery may be identified before or during surgery and used as real-time triggers to control the therapeutic delivery system; Paragraph [0023]; Effectively, automated therapeutic delivery can be performed by using OCT-guided feedback, including a position or depth of injection site), calculate an optimal path of the surgical instrument to a spatial target position (Paragraphs [0013]-[0016]; to locate specific treatment positions, and specific tissue layers targeted…; The process of locating the treatment position and automatically moving the injection the injection site includes calculating an optimal path to the spatial target position as understood in its broadest reasonable interpretation).
Regarding claim 10, together Srivastava, Larin, and Milner teaches all of the limitations of claim 1 as noted above.
Srivastava further teaches the computer unit is further configured to execute the computer program to determine as a fourth guide variable a target value for the volume of the released medium (Paragraph [0020]; dosage tracking component 60 is configured to monitor the delivery of the therapeutic… and determine a delivered volume from the identified therapeutic; Paragraph [0029]; this can include stopping delivery of the therapeutic when a desired dosage is achieved; The desired dosage is considered to read on the claimed limitation of a guide variable as understood in its broadest reasonable interpretation) by processing the target area in the one or more 3-D reconstruction of the object region volume and/or by processing data determined presurgery and/or by processing OCT scanning information obtained by means of the OCT device by scanning the object region volume and/or by way of an input of a target value by a surgeon (Paragraph [0013]; appreciated that the system 10 can be configured to assist a user in manually performing a delivery of therapeutics to the eye; Paragraphs [0028] and [0029]; such that a net delivered dosage can be calculated; a desired dosage is achieved; The choice of a desired dosage is understood to read on the claimed limitation as understood in its broadest reasonable interpretation).
Regarding claim 11, together Srivastava, Larin, and Milner teaches all of the limitations of claim 1 as noted above.
Srivastava further teaches the computer unit is further configured to execute the computer program is designed to determine as a fifth guide variable for a readjustment of the volume of the released medium a difference between a target value and an actual value of the volume of the medium released into the target area (Paragraphs [0028]; an amount of therapeutic delivered to the eye can be tracked to determine a total dosage. This tracked volume can be refined by measuring leakage of the delivered therapeutic from the delivery site, such that a net delivered dosage can be calculated; The net delivered dosage is considered to read on the claimed limitation of a guide variable for a readjustment of the volume as understood in its broadest reasonable interpretation).
Claims 3, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava in view of Larin and Milner as applied to claims 1 and 5 above, respectively, and further in view of Boyd (US 20210279874).
Regarding claim 3, together Srivastava, Larin, and Milner teach all of the limitations of claim 1 as noted above.
Together Srivastava, Larin, and Milner do not explicitly teach the computer unit is further configured to execute the computer program to determine a relative spatial position of data in relation to one another by a registration method, said data in relation to one another comprising (1) the scanning information obtained by the OCT device by scanning the object region volume, (2) the object region volume, (3) data from further imaging methods comprising optical image representations, magnetic resonance imaging (MRI) data, computed tomography (CT) data, ultrasound images, or endoscopy images, (4) the position of the section of the surgical instrument, (5) the preoperatively determined data, and/or (6) position sensor signals.
Boyd, however, teaches the computer unit further configured to execute the computer program to determine a relative spatial position of data in relation to one another by means of a registration method (Paragraph [0115]; the method can provide for registration 410 two or more images 802, 804 with one another by establishing point correspondences between the images or a target image space; correlation and/or feature location matching), said data in relation to one another comprising scanning information obtained by means of the OCT device by scanning the object region volume (Paragraph [0115]; or between images of different modalities, such as OCT, OCTA), the object region volume (Paragraph [0156]; 3-dimensional (3D) volumetric reconstruction in other methods such as OCT), data from further imaging methods (Paragraph [0115]; between images of different modalities, such as DNIRA alongside FAF, OCT, fundus photo, red free, Infrared (IR), angiography, and OCTA images), in comprising, MRI data, CT data, ultrasound images, endoscopy images, a position of the section of the item, and/or data determined presurgery (Paragraph [0293]; undergo registration, alignment and segmentation… where baseline (pre-ICG injection) images have demonstrable signal prior to ICG injection).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the computer program of Srivastava in view of Larin and Milner to have included determining the relative spatial position of data in relation to one another by means of a registration method, said data comprising data from the following group: scanning information obtained by means of the OCT device by scanning the object region volume, the object region volume, data from further imaging methods, in particular optical image representations as taught by Boyd because it would have accommodated for slight changes in alignment, tilt, skew, magnification and any other parameters that may vary across each patient visit between imaging sets (Boyd, Paragraph [0019]).
Regarding claim 6, together Srivastava, Larin, and Milner teach all of the limitations of claim 5 as noted above.
Together Srivastava, Larin, and Milner do not explicitly teach the computer unit is further configured to execute the computer program to determine a position and/or dimensions of blood vessels in the target area based on the OCT angiography data and determine the target area in the one or more 3-D reconstruction of the object region volume based on a course and/or the position and/or the dimensions of the blood vessels in the target area.
Boyd, however, teaches the computer unit is further configured to execute the computer program to determine the position and/or dimensions of blood vessels in the target area based on the OCT angiography data (Paragraph [0099]; several characteristic features, such as vessels… segmentation unit 404 can segment regions of the image and features of interest in the image acquired in the first visit to serve as the baseline for size and shape of feature.) and determine the target area in the one or more 3-D reconstruction of the object region volume taking account of the course and/or the position and/or the dimensions of the blood vessels in the target area (Paragraphs [0008] and [0099]; the segmentation analysis can be based on one or more features… comprise features selected from the group consisting of: blood or blood vessels).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the program of Srivastava in view of Larin and Milner to determine the position and/or dimensions of blood vessels in the target area on the basis of the OCT angiography data and determining the target area in the one or more 3-D reconstruction of the object region volume taking account of the course and/or the position and/or the dimensions of the blood vessels in the target area as taught by Boyd because it would have been a useful reference point in segmentation that is unlikely to change overtime and thus improve comparison of images (Boyd, Paragraph [0099]).
Regarding claim 9, together Srivastava, Larin, and Milner teaches all of the limitations of claim 1 as noted above.
Together Srivastava, Larin, and Milner do not explicitly teach the computer unit is further configured to execute the computer program to determine the target area and/or a target position for the surgical instrument in the preoperatively determined data, register the preoperatively determined data with the one or more 3-D reconstruction of the object region volume, and transfer the target area and/or the target position in the preoperatively determined data to the one or more 3-D reconstruction of the object region volume.
Boyd, however, teaches the computer unit is further configured to execute the computer program to determine a target area and/or a target position for the surgical instrument in preoperatively determined data, register the preoperatively determined data (Paragraph [0115]; the method can provide for registration 410 two or more images 802, 804 with one another by establishing point correspondences between the images or a target image space; Paragraph [00289]; Images are obtained prior to systemic injection) with the one or more 3-D reconstruction of the object region volume (Paragraph [0134]; Cross-sectional methods include: Optical Coherence Tomography (OCT)… 3D reconstructions that generate graphical representations of the cross-sectional imaging) and transfer the target area and/or the target position in the preoperatively determined data to the one or more 3-D reconstruction of the object region volume (Paragraph [0097]; Registration 410 can receive registration parameters 422 to transform different sets of image data from the stored ocular images 412 from a reference image space to a target image space using transformation models; Paragraph [0400]; composites allow for correlation of the novel imaging method with current clinical modalities… identification of regions of interest including the tumour region (i), areas of current or previous fluid (ii), and peripheral (extra-lesional) regions (iii); the steps of registering images and creating composite images of target areas is understood to read on the claimed limitation of transferring the target area and/or the target position in the data determined presurgery to the 3-D reconstruction of the object region volume as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Srivastava in view of Larin and Milner to include determining the target area and/or a target position for the surgical instrument in the preoperatively determined data, registering the preoperatively determined data with the one or more 3-D reconstruction of the object region volume, and transferring the target area and/or the target position in the preoperatively determined data to the one or more 3-D reconstruction of the object region volume as further taught by Boyd. This would have provided the ability to compare or integrate the image data obtained from different modalities, formats, and measurements, thereby allowing monitoring of the specific target tissues between presurgical and interoperative scans.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Srivastava in view of Larin and Milner as applied to claim 7 above, and further in view of Ren (US 20180078315).
Regarding claim 8, together Srivastava, Larin, and Milner teach all of the limitations of claim 7 as noted above.
Together Srivastava, Larin, and Milner do not teach the criterion is a measure of shadowing that quantifies the presence of shadows caused by the item in the calculated one or more 3-D reconstruction.
Ren, however, teaches an imaging and surgical system (Paragraph [0008]; Methods, devices, and systems for determining an orientation of a surgical tool during ophthalmic surgery) comprising a path planning routine (Paragraph [0040]; image processor 126 may display and overlay indicators to indicate… surgical data for surgical guidance) including a criterion (Paragraph [0047]; by determining the center of the shadow in the OCT image) that is a measure of shadowing that quantifies the presence of shadows caused by the item in the calculated one or more 3-D reconstruction (Paragraph [0054]; As discussed above, this may involve identifying a “gap” in the scan image, caused by the shadowing of the scan by the surgical tool. Typically, the contrast between this gap and the surrounding image data will be quite high; Paragraph [0045]; the location of the center of the tool shaft can be reliably and accurately detected through OCT image processing; The location of the center of the tool from the gap of the shadow is understood to read on the claimed limitation of quantifying the presence of shadows as understood in its broadest reasonable interpretation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Srivastava in view of Larin and Milner to have included using a criterion that is a measure of shadowing that quantifies the presence of shadows caused by the item in the calculated one or more 3-D reconstruction as taught by Ren because it would have allowed the tool shadow to be avoided all or most of the time during the surgical procedure, thereby ensuring the tool is properly tracked during the procedure, and further allow monitoring of several areas around the target region while tracking the tool tip (Ren, Paragraphs [0026]-[0028]).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Srivastava in view of Larin and Milner as applied to claim 1 above, and further in view of Papac (US 20180055581).
Regarding claim 12, together Srivastava, Larin, and Milner teaches all of the limitations of claim 1 as noted above.
Together Srivastava, Larin, and Milner do not teach the computing routine of the computer program serves to determine as a guide variable the position of a substance to be removed and/or an amount of substance to be removed by processing the target area in the one or more 3-D reconstruction of the object region volume and/or by processing data determined presurgery and/or by way of the input of a target value by a surgeon.
Papac, however, teaches a computing routine of the computer program (Paragraph [0012]-[0014]; mechanisms for assisting physicians during surgeries including ophthalmic surgery; Further, aspects of the method and system may take the form of a software component(s) executed on at least one processor) serves to determine as a guide variable the position (Paragraph [0023]; For example, for ERM removal, the next recommended procedure (a cut) at a particular, recommended region) of a substance to be removed (Paragraph [0022]; for ERM removal, the next procedure is typically cutting a section of the ERM) and/or an amount of substance to be removed by processing the target area (Paragraph [0020]; the stresses in particular regions may be determined from the distortions seen in the quasi-real time image data at various IOPs) in the one or more 3-D reconstruction of the object region volume (Paragraph [0017]; quasi-real time image(s) may include optical coherence tomograph(s) (OCTs)… the quasi-real time image may include the volume of the eye or simply a cross-section of the eye) and/or by processing data determined presurgery (Paragraph [0025]; The image 200 may be or be part of a quasi-real time image taken just before) and/or by way of the input of a target value by a surgeon (Paragraph [0042]; the operator may input instructions and receive output from the U/I 340. For example, the operator may set the regions of the eye 302 scanned by the imaging system 310, view results or otherwise provide instructions and receive output from the system 300).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the system of Srivastava in view of Larin and Milner to include steps to determine as a guide variable the position of a substance to be removed and/or an amount of substance to be removed by processing the target area in the one or more 3-D reconstruction of the object region volume and/or by processing data determined presurgery and/or by way of the input of a target value by a surgeon as taught by Papac. This would allow assisting a surgeon in determining which portions of the eye to cut and in what order during the operation (Papac, Paragraph [0019]) to reduce the risk of damage during the operation.
Regarding claim 13, together Srivastava, Larin, Milner, and Papac teach all of the limitations of claim 12 as noted above.
Papac further teaches a visualization routine for visualizing the position of the substance to be removed and/or the amount of substance to be removed in the object region volume (Paragraph [0021]; Step 104 may also include generating a visual model of the eye… regions which are more problematic and/or are likely candidates for the next procedure are determined; Paragraph [0026]; image 200 shown in FIG. 2A with recommended regions 232 and 234 highlighted. Because the ERM 230 is to be removed, the recommended procedure (cutting the ERM 230) is inherently known. The image 200′ may be rendered on a graphical display for the physician to view).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have further modified the system of Srivastava in view of Larin, Milner, and Papac to include a visualization routine for visualizing the position of the substance to be removed and/or the amount of substance to be removed in the object region volume as further taught by Papac. This would allow the surgeon to view the recommended cut and removal procedure and further improve guidance during the surgery (Papac, Paragraph [0026]).
Response to Arguments
Claim Objections
The amendments to the claims raise new objections which are now presented.
Claim Rejections under – 35 U.S.C. § 112(b)
Examiner acknowledges the amendments to the claims and withdraws all previous rejections under 35 USC 112(b).
Claim Rejections under – 35 U.S.C. § 103
Applicant’s arguments with respect to the previous 35 U.S.C. § 103 rejections have been considered but are moot in view of the updated grounds of rejection necessitated by amendments.
Conclusion
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/DEAN N EDUN/Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
03/23/26