DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant's submissions filed on 06/12/2026 and 07/22/2026 have been entered. Accordingly, claims 1-25 remain pending, and claims 1, 6-7, 16, 18, 23, and 24 have been amended, claims 8 and 19 have been canceled, and claim 26 has been added.
Response to Arguments
Drawing Objections
Applicant's arguments filed 06/12/2026 and 07/22/2026 have been fully considered but they are not persuasive.
Applicant states in the second paragraph of page 7 through the final paraph of page 9 of the response filed 06/12/2026; the fifth from final paragraph of page 10 through the eighth paragraph of page 11 of the response filed 07/22/2026
“’the risk map’:
This feature is shown in Fig. 5 (step 510).
‘the optical face mesh’:
This feature is shown in Fig. 1 (step 100) and Fig. 2 (emphasis added)”.
In response, with specific regard to the three-dimensional image of the face of the patient, the ultrasound image of the face of the patient, the patient-specific composite model, the tracker is electromagnetic, the tracker is optical, the retention mechanism and the anti-rotation feature of the cradle, the optical sensors or electromagnetic sensors integrated into the wearable headband, the kinematic constraint of six degrees of freedom provided by the mount, the repeatable and stable reattachment of the mount, the mound without recalibration of the ultrasound probe, the simulated model based on a volumetric effect of injections at the one or more target locations, the simulated model of predicted volumetric effects to determine injection location, injection trajectory, dynamically deforming the patient-specific composite model to compensate for expression-induced tissue displacement during injection, the tracker is lidar-based, the first interface of the mount configured to couple with the ultrasound probe and the second interface mount configured to couple with the tracker, the one or more target locations presented upon the face of the patient, the one or more target locations presented upon the face of the patient, injecting the one or more target locations with filler material via a syringe these specific drawing objections have been withdrawn. However, the remaining objected to objected to subject matter recited in the claims remain objected to.
For example, but not limited to, applicant indicates that the “risk map” as being “shown in Fig. 5 (step 510)”, however box 510 in FIG. 5 is labeled “GENERATE SAFE OR UNSAFE REGIONS” and applicant indicates the “optical face mesh” as being “is shown in Fig. 1 (step 100) and Fig. 2”, however applicant has not indicated what reference character in FIG. 2 as being the optical face mesh. Accordingly, the drawing objections have been updated in accordance with applicant’s presented arguments and the newly present claim amendments.
It is noted that applicant has amended specification filed 07/22/2026 so that the treatment plan 400 seen in FIG. 4C comprises “a risk map”, however, no map is shown or indicated by reference number 400 in any of FIGS. 4A-4F, neither as filed 12/10/2025 nor as filed 07/22/2026. See the attached interview summary.
Rejections under 35 USC 112
In light of applicant’s claim amendments filed 07/22/2026, the previous rejections under 112(a) have been rendered moot and have been withdrawn.
Regarding the rejections under 112(b), the specific lack of antecedent basis rejection of claim 1 has been rendered moot by the present rejections and has been withdrawn. However, applicant’s newly filed amendments introduce new clarity issues to the claims. See the rejections outlined below.
The previous rejections of claims 6-7 have been rendered moot by the amendments to claims 6-7 filed 06/12/2026 and the canceling of claim 8 and the claim amendments filed 07/22/2026.
Rejections under 35 USC 103
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive.
Applicant argues in the final paragraph of page 13 through the third paragraph of page 14
“Bangera does not cure the deficiencies of Rios. The Office action relies on Bangera for the teaching of an ultrasound probe configured to generate an ultrasound image and the registration of the ultrasound image and the three-dimensional image into a patient-specific composite model. Specifically, the Office action cites paragraphs [0206] and [0219] and Fig. 27 of Bangera, which disclose that ‘the one or more digital images that are acquired are then brought into a computing device which aligns or registers the images into a common coordinate system and then integrating the images into a single three-dimensional model that a digitally rendered model is created of the wearable injection guide from the one or more digital images of face of the patient.’ However, Bangera does not teach or suggest registering, by a processor, an ultrasound image specifically with a three-dimensional optical image into a patient-specific composite model in the manner claimed. Rather, the registration is directed to aligning digital images into a common coordinate system for the purpose of creating a wearable injection guide, not for creating a patient-specific composite model that integrates subsurface ultrasound-derived volumetric data with an external optical three-dimensional image of the patient's face. The claimed registration step produces a fused model that captures both the external surface anatomy and the underlying subsurface structures, including vasculature, in a single patient-specific composite model.
With respect to the feature ‘wherein the augmented reality device overlays the
patient-specific composite model over the patient in real-time to reflect patient movement,’ neither Rios nor Bangera teaches or suggests this feature. Rios discloses an augmented reality display system that relies on static alignment targets, such as reflective beads placed on the patient, to align the computer-generated overlay with the patient's face (para. [0072]). However, this static marker-based approach does not dynamically update the overlay to reflect patient movement in real time, and accordingly Rios does not teach an augmented reality device continuously tracking and compensating for patient movement while maintaining registration of the composite model overlay with the patient's actual anatomy.
Bangera does not cure this deficiency, as Bangera is relied upon solely for its
teaching of an ultrasound probe and image registration and contains no disclosure of an augmented reality device that dynamically updates an overlay in real-time to reflect patient movement…”.
In response, applicant is directed to page 16 of the office action mailed 03/12/2026 in which [0106], [0206], [0207], [0217], [0219], FIGS. 27, 29 of Bangera was cited as teaching the limitations of the ultrasound probe, the ultrasound probe configured to generate an ultrasound image of the face of the patient and wherein the ultrasound image and the three-dimensional image are registered into a patient-specific composite model. Regarding applicant’s newly filed claim amendments with respect to the registration step, applicant is additionally directed to [0214], [0286]-[0287], [0292] of Bangera for teaching this limitation. See as cited in the updated prior art rejection below.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “registering, by a processor, an ultrasound image specifically with a three-dimensional optical image into a patient-specific composite model” (emphasis added)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the newly recited limitation of “wherein the augmented reality device overlays the patient-specific composite model over the patient in real-time to reflect patient movement”, applicant is directed to [0064], [0073], [0074], [0076], [0078], FIG. 4 of primary reference Rios for disclosing this limitation.
Further, as noted above, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “compensating for patient movement while maintaining registration of the composite model overlay with the patient's actual anatomy” and “dynamically update the overlay to reflect patient movement in real time” (emphasis added)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Therefore, the claims remain rejected and the rejection has been made final.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the risk map, the optical face mesh in FIG. 2 – all must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
The drawings are objected to because throughout the figures there are multiple unlabeled and non-identified structures in each of the figures, and in some figures, there are structures and text that are not discernable due to resolution and greyscale used, which appears, although unclear that these pictures contain colored information. However, no petition to have colored figures has been filed. 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Rejections - 35 USC § 112
All dependent claims are also rejected by the nature of their dependency.
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 1- 7, 9-18, 20-24, and 25 are 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 1 recites the limitation "the one or more target locations" in line 19. There is insufficient antecedent basis for this limitation in the claim. The claim does not previously recite one or more target locations, therefore it is unclear to what the one or more target locations applicant refers.
Claim 16 is also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Further, claim 1 has been amended to recite “constrain the risk map to determine the one or more target locations based on the one or more safety zones” “evaluate the patient-specific composite model to select one or more target locations on the face of the patient constrained by the one or more safety zones of the risk map” in lines 16-18, which renders the claim indefinite because it is unclear if applicant meant when reciting that the map as being constrained, applicant meant instead to recite “constrain the risk map based on the one or more safety zones in order to determine one or more target locations”.
It is also unclear if the evaluation step involves performing the functional step of actively constraining one or more target locations on the face of the patient by the one or more safety zones of the risk map or if this is a different step or if the one or more target locations recited in the immediate limitation are different from the one or more target locations recited earlier in the claim.
Claims 2, 15-17, 20-21, and 22 are also rejected for reciting the same and/or limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
The following suggested amendments to the independent claims may help overcome the above rejections:
“…constrain the risk map based on the one or more safety zones to determine on the face of the patient
evaluate the patient-specific composite model in order to select the one or more target locations on the face of the patient based on the one or more safety zones of the constrained risk map;
select the one or more target locations on the constrained risk map; and…”.
All dependent claims should be also amended to be congruent with in amended parent claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, 7, 16-18, 20, 22-25, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Rios et al. (US20170252108, hereafter “Rios”), in view of Bangera et al. (US20140039658, hereafter “Bangera”).
Regarding claims 1, 5, and 16, Rios discloses a system and a method for planning an aesthetic procedure on a patient (see abstract, systems and methods for an apparatus and method for practicing injection techniques via an injectable apparatus), the system and method comprising:
a tracker configured to obtain three-dimensional image data of a face of the patient ([0018], [0044], [0050], [0058] using a scanner/tracker to obtain three-dimensional position image data of the target of the face of the patient by tracking one or more landmarks on the observed target so that the at least one of a movement of the observed target and a location of the observed target may be measured relative to a user);
an ultrasound probe, the ultrasound probe configured to generate an image of the face of the patient ([0013], [0084] the scanner configured to interact with one or more landmarks on the treatment target on the face of the patient to measure a location of at least one of the injection tool and the display device relative to the treatment target on the face of the patient, the scanner using ultrasonic projectors to sense the location); and
a processor configured to:
receive the three-dimensional image data ([0047] the computing system 104 is configured to receive the information);
generate a three-dimensional image of a face of the patient based on the three-dimensional image data ([0018], [0044], [0050], [0058] using the data obtained by the scanner/tracker including the three-dimensional position of the target of the face of the patient that was obtained by tracking the one or more landmarks on the observed target and then measuring the at least one of a movement of the observed target and a location of the observed target relative to a user to generate a corresponding digital 3D model personalized for the patient);
register the image and the three-dimensional image into a patient-specific composite model ([0051], [0071], [0073], FIG. 5, by the injection aid system which merges/registers the patient imaging data with the scanned position of the patient relative to the display device, the display device then overlays a computer-generated three-dimensional image(s) on the treatment targets located on the patient’s face, the one or more treatment icons are projected and represent an injection site on each corresponding treatment target located on the patient’s face, and the user can cause to be displayed the desired portion of the anatomy);
identify anatomical features of the patient-specific composite model ([0051], [0073], FIGS. 1, 4-5, the injection aid system merges the patient imaging data with the scanned position of the patient relative to the display device and the display overlays a computer-generated three-dimensional image(s) on the treatment target);
identify a vasculature of the patient from the patient-specific composite model ([0051], [0053], [0059] the computer-generated model corresponds to one or more blood vessels/vasculature for the specific target, allowing the user to see/identify the underlying structure of the anatomy, such as blood vessels/the vasculature, thereby the three-dimensional interactive exploration of injection sites can be performed to identify nearby vessels/vasculature);
derive a risk map from the patient-specific composite model, the risk map comprising one or more safety zones and one or more risk zones based on spatial proximity of the vasculature of the patient to calculated injection trajectories ([0071], [0073], FIGS. 4-5, the display displays the anatomy of the patient in the digital model is projected to appear on the treatment target along with displayed information, the displayed information includes: preferred injection sites, with color and or shape symbols coded to indicate medication type, volume depth of injection along with needle angle, medication delivery guides and nearby anatomy risks);
constrain the risk map to determine the one or target locations based on the one or more safety zones ([0071]-[0072], FIG. 5, the risk map is displayed with color and or shape symbols coded to indicate medication type, volume depth of injection along with needle angle, medication delivery guides and nearby anatomy risks by way of the anatomy in the digital model is projected to appear on the treatment target so that the injection aid system simulated and under the skin view which includes anatomical features with a “see-through” view so that critical structures such as arteries, veins, nerves, fat, and muscles as well as the injection tool are projected onto the image of the treatment target, therefore the treatment target may be determined based on/constrained by the viewed location of the desired treatment target with respect to the location of critical structures such as arteries, veins, nerves, etc.);
select the one or more target locations on the risk map ([0070]-[0072], FIG. 5, one or treatment icons are projected onto the selected one or more treatment sites located on the risk map); and
evaluate the patient-specific composite model to select one or more target locations on the face of the patient constrained by the one or more safety zones of the risk map (([0051], [0053], [0067], [0069], FIG. 5, the user selects a display format that provides increased or altered perception of the virtual anatomical structure being injected and the display device that may selectively display information to the user so that the overlayed 3D computer-generated image(s) correspond to one or more layers of anatomy including the location of bones, nerves, blood vessels for each target being viewed on the face of the patient [0006], [0053], [0059], [0067], [0073], FIG. 4-5, the displayed virtual environment provides access to contexts that are dangerous, e.g., procedures that present an unacceptable risk to a patient to identify the location of high risk tissue to avoid the accidental misplacement of medication and resulting health impact by projecting information on the display in the form of numerical values, colored shapes, bar charts, grids, tissue structures including arteries and veins by simulating the under skin anatomical features as a see through view which is able to convey critical tissue information such as arteries and veins so that they may be identified by the user viewing the display that are displayed as hazard zones, the locations of the hazard zones have been determined by the injection aid system and accordingly, the hazard zones are projected onto the display device to avoid misplaced medication and/or resulting harm); and
a display, wherein the display shows the patient-specific composite model ([0051], [0073], FIGS. 1, 4-5, the injection aid system merges the patient imaging data with the scanned position of the patient relative to the display device and the display overlays a computer-generated three-dimensional image(s) on the treatment target) and the risk map comprising the one or more safety zones and the one or more risk zones ([0006], [0053], [0059], [0067], [0073], FIG. 4-5, the displayed virtual environment provides access to contexts that are dangerous, e.g., procedures that present an unacceptable risk to a patient to identify the location of high risk to avoid the accidental misplacement and resulting health impact by projecting information on the display in the form of numerical values, colored shapes, bar charts, grids, tissue structures including arteries and veins).
And with specific regard to claims 5 and 16, Rios discloses wherein the three-dimensional image comprises an optical face mesh ([0083], FIG. 7, a polygon-based objects is rendered as a model mesh of the patient, which is illustrated in FIG. 7).
And with specific regard to claim 16, Rios discloses digitally presenting the one or more target locations for treatment directly upon the face of the patient ([0064], [0073], [0106], FIGS. 4, 12, the social aid system projects information at a location directly overlaying the field of view of the user, the field of view comprising the face of the patient).
The ultrasound probe and the image of the face of the patient as disclosed by Rios are not explicitly disclosed as being generated by the ultrasound probe configured to generate an ultrasound image of the face of the patient, nor the step of registering the three-dimensional image and the image into a patient-specific composite model that are disclosed by Rios are explicitly disclosed as being the ultrasound image and the three-dimensional image.
However, in the same field of endeavor, Bangera teaches an ultrasound probe, the ultrasound probe configured to generate an ultrasound image of the face of the patient ([0106], [0207], [0214], [0217], FIGS. 27, 29, more contact scanners can be used to acquire one or more digital images of the body region of an individual by running a probe over the surface of the face of the patient, where the scanner uses ultrasound to obtain the images), registering the ultrasound image and the three-dimensional image into a patient-specific composite model ([0206], [0219], [0286]-[0287], [0292], FIG. 27, the computing device registers a three-dimensional image of the body region of the individual which becomes the basis for the digitally rendered model with the one or more digital images that are acquired into a common coordinate system and then integrating the images into a single three-dimensional mode so that a digitally rendered model is created of the wearable injection guide from the one or more digital images of face of the patient).
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 and system disclosed by Rios with the ultrasound probe configured to generate an ultrasound image of the face of the patient and registering the ultrasound image and the three-dimensional image are a patient-specific composite model as taught by Bangera in order so that superficial blood vessels on the face of the individual can be imaged and incorporated into the digitally rendered model of the wearable injection guide ([0211] of Bangera).
Regarding claims 2 and 18, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses further comprising a syringe configured to inject the one or more target locations with a filler material ([0058], [0087]-[0092], [0119], FIG. 9, including a prefilled syringe, and the injection aid system determines an accumulated injection for the current target of the predetermined targets identified by a target 3-dimensional location which have been predetermined for product delivery), wherein the syringe is guided by analysis of the patient-specific composite model ([0058], [0092], FIG. 9, the personalized 3D facial model mesh is used for filler injection modeling and visualization).
Regarding claim 3, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses wherein the syringe comprises a sensor module ([0011] the injection tool comprises a positional sensor configured to sense a position and an orientation of the injection tool), the sensor module comprising a housing configured to hold a sensor ([0011] the injection tool comprises a positional sensor configured to sense a position and an orientation of the injection tool).
Regarding claim 7, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses wherein the tracker is an optical sensor ([0012] the optical tracking system comprises a light sensor; an infrared light source, positioned around the light sensor, configured to emit infrared light; an infrared filter positioned in front of the light sensor configured to cause the light sensor to detect infrared light emitted from the infrared light source).
Regarding claim 17, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses further comprising treating the one or more target locations based on the one or more target locations presented upon the face of the patient ([0054], [0074] the remote treatment expert may communicate with the user to assist in the medical injection procedure to treat living patients based on communicated positions and orientation information provided by the injection tool as the injection tool approaches the treatment target on the face of the patient, sensory indicators may be displayed, in an overlay on the face of the patient, to indicate proximity of the virtual tool to the desired target location on the face of the patient).
Regarding claim 20, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses further comprising creating a simulated model based on a volumetric effect of injections at the one or more target locations ([0097] the model mesh may be distorted to visually show the volumetric effect of filler injections by moving the closest few vertices outward along the face normal (i.e., perpendicular) to the skin surface and proportional to face size, this will cause the effect of increasing the volume under the skin by the volume of the filler added).
Regarding claim 22, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses wherein the one or more target locations is associated with one or more parameters selected from: injection trajectory, target depth, and injection volume ([0069], FIG. 5, one or more parameters projected on the display device includes position and angle of the injection tool, track of needle tip, location of injection, injection track, depth of injection at the target, angle of injection, volume of injection, position/location of targeted anatomy).
Regarding claim 23, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses further comprising an augmented reality device configured to be worn by a practitioner to provide live visualization of the patient-specific composite model and the patient during injection ([0066] a model of the patient's anatomy is display on the head-mounted display device of the augmented reality glasses), wherein the augmented reality device overlays the patient-specific composite model over the patient ([0066], [0073] an augmented reality system is blended with data from an imaging modality to enable live tissue injections to display a model of the patient's anatomy).
Regarding claim 24, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses wherein evaluating the patient-specific composite model further comprises evaluating a simulated model of predicted volumetric effects to determine injection location ([0073] the injection aid system determines the preferred injection schedule which includes information relating to the injection locations), injection trajectory ([0073] the injection aid system determines the preferred injection schedule which includes information relating to the medication type, angles, depth, volume, and additional information), and injection volume ([0097] the model mesh may be distorted to visually show impact of filler injections by moving the closest few vertices outward along the face normal (i.e., perpendicular) to the skin surface and proportional to face size, this will cause the effect of increasing the volume under the skin by the volume of the filler added).
Regarding claim 25, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses further comprising:
tracking the face of the patient in real time ([0061] images of the patient’s face are displayed images can be real-time and/or progressive over the duration of the procedure in real-time and/or progressive over the duration of the procedure);
inferring facial expression using a classification algorithm ([0008], [0013] information representative of at least one of an underline musculature of the treatment target and a facial expression scan of the treatment target is contained in the pre-operative imaging data obtained by a scanner configured to measure a facial expression of the treatment target and determine an underlying anatomy and a muscle motion); and
dynamically deforming the patient-specific composite model to compensate for expression-induced tissue displacement during injection ([0068], [0068] scanner is configured to track facial expressions, collect multiple high-resolution scans, determine underlying anatomy, and muscle motion/displacement of muscle position at rest during when facial expressions are being exercised, e.g., smiling, frowning, yawning, shrugging, laughing, resting, among others, and then generate an anatomical model which is enhanced using known Eulerian capture techniques).
Regarding claim 26, Rios substantially discloses all the limitations of the claimed invention, specifically Rios discloses an augmented reality device configured to be worn by a practitioner ([0063], FIG. 4, see AR headset 400) to provide live visualization of the patient-specific composite model and the patient during injection ([0063]-[0064] a model based on the patient's anatomy is generated by the injection aid system/AR headset 400 as a graphical overlay, identifying the target 424 location for injection and the vital structures 428 live to be avoided can be superimposed on the user's field of view during the procedure), wherein the augmented reality device overlays the patient-specific composite model over the patient in real-time to reflect patient movement ([0064], [0073]-[0074], [0076], [0078], FIG. 4, the treatment target 416 that may comprises live tissue and the generated mesh/model moves in accordance with a corresponding target movement in the view of the operator wearing the AR headset 400 to view the treatment procedure in real time).
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rios, in view of Bangera, as applied to claim 1 above, further in view of Rios et al. (US20240153404, hereafter “Rios ‘3404”).
Regarding claim 4, Rios substantially discloses all the limitations of the claimed invention, specifically, Rios discloses wherein the syringe comprises a finger rest (see FIG. 4, see the flanges on syringe 412 with user’s fingers illustrated as resting on the flanges located to the left of the user’s fingers and the thumb on the plunger, between the flanges) and a housing configured to hold a sensor ([0011], [0016], [0046], [0049], [0054], the injection tool comprises a force sensor configured to detect and measure a force exerted on the plunger which is applied by the user on the plunger of the injection tool during an injection to calculate an accumulated injection amount based on the detected force applied to the plunger, and measure the displacement of the plunger of the injection tool), but does not explicitly disclose the finger rest as comprising a housing configured to hold a sensor.
However, in the same field of endeavor, Rios ‘3404 teaches a finger rest comprising a housing ([0065], see flanges 134, 135, 136 in FIG. 1A which form two finger supports on diametrically opposite sides of the syringe body portion) configured to hold a sensor (see 121, 180, 186, 184, 191, 192 in FIGS 1A-1B, 2, 3).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Rios with the finger rest comprising a housing configured to hold a sensor as taught by Rios ‘3404 in order to measure position, such as an x-y-z position, and/or orientation of the syringe ([0062] of Rios ‘3404).
Claim(s) 6, 9, 10-11, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Rios, in view of Bangera, as applied to claim 1 above, further in view of Cosman et al. (US6122541, hereafter “Cosman”).
Regarding claim 6, Rios substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the tracker is an electromagnetic sensor.
However, in the same field of endeavor, Cosman teaches wherein the tracker is an electromagnetic sensor (column 6, lines 35-39, column 9, lines 45-48, many types of reference/tracking systems or techniques could be imagined, for example, electromagnetic coupling and the point of the space probe or digital navigator might be touched to one of the reference/tracking markers, and thereby the coordinates of the reference marker with respect to the stereotactic coordinate system can be determined).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Rios with the tracker being an electromagnetic sensor as taught by Cosman in order for a navigator system can be continuously monitoring the position of the dynamic reference markers on the patient attachment device and a correction can be made to the coordinate transformation to take into account this rearrangement of the patient's head (column 4, lines 52-57 of Cosman).
Regarding claim 9, Rios, in view of Bangera, substantially discloses all the limitations of the claimed invention, specifically, Bangera discloses further comprising a wearable headband configured for use on the patient as a stable reference frame for motion compensation ([0154], FIG. 7), wherein the wearable headband comprises a cradle configured to receive the tracker ([0010], [0018], [0108], FIG. 12, a head band is used to secure the device on a user's head); but does not explicitly disclose further comprising a wearable headband configured for use on the patient as a stable reference frame for motion compensation, wherein the wearable headband comprises a cradle configured to receive the tracker.
However, in the same field of endeavor, Cosman teaches further comprising a wearable headband configured for use on the patient as a stable reference frame for motion compensation (column 5, lines 48-57, a coordinate system which is affixed to the patient and therefore in a rigid body orientation relative to the head band, such as the dynamic reference markers, will also move when a patient’s head moves in order to take into account rotation movement by the movement in terms of translation and rotation of the head band dynamic reference markers, so that a correction can be made to the coordinate transformation to take into account this rearrangement of the patient's head), wherein the wearable headband comprises a cradle configured to receive the tracker (see cradles 415, 615 in FIGS. 4, 6).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Rios with the wearable headband configured for use on the patient as a stable reference frame for motion compensation and the wearable headband comprising a cradle configured to receive the tracker taught by Cosman in order to provide an apparatus, a means, and associated technique, which can easily attach to and which may be repeatedly re-attached to the patient's anatomy, desired (column 2, lines 23-25 of Cosman).
Regarding claim 10, Rios substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the cradle comprises a retention mechanism and an anti-rotation feature.
However, in the same field of endeavor, Cosman teaches wherein the cradle comprises a retention mechanism and an anti-rotation feature* (column 7, lines 61-66, FIG. 4, the cradle comprises a docking platform which includes a plate with, for example, index pin holes and a threaded hole to secure other devices to the head band such as dynamic reference markers or graphic reference structures).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Rios with the cradle comprises a retention mechanism and an anti-rotation feature as taught by Cosman in order to provide a repeat reference frame is possible with such a head band (column 7, lines 56-57 of Cosman).
*For the purposes of examination, the term has been interpreted under the broadest reasonable interpretation to be inclusive of any structural or functional mechanism or method or technique known in the art to be able to secure the tracker or assist in aiding to prevent the tracker from rotating while in the cradle.
Regarding claim 11, Rios substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein the wearable headband is configured to be integrated with optical sensors or electromagnetic sensors.
However, in the same field of endeavor, Cosman teaches wherein the wearable headband is configured to be integrated with optical sensors* (see 220, 221, 222 are part of the headband in FIG. 2 which are light-emitting diodes or other optically reflecting or optically visible objects).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Rios with the wearable headband being configured to be integrated with optical sensors or electromagnetic sensors as taught by Cosman in order to determine the movement of a coordinate system which is affixed to the patient and therefore in a rigid body orientation relative to the head band when the patient’s head moves (column 5, lines 45-48 of Cosman).
*For the purposes of examination, this limitation has been interpreted in the alternative, requiring the wearable headband is configured to be integrated with optical sensors; or requiring the wearable headband is configured to be integrated with electromagnetic sensors.
Regarding claim 21, Rios substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein creating the simulated model comprises selecting the one or more target locations with a stylet.
However, in the same field of endeavor, Cosman teaches wherein creating the simulated model comprises selecting the one or more target locations with a stylet (column 5, lines 9-10-12, see 225 in FIG. 2 which the position of the probe/stylet in real space can be mapped to its virtual position in the image space or scanner coordinate system of the image scan data).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Rios creating the simulated model comprises selecting the one or more target locations with a stylet as taught by Cosman in order to display a position of the space probe can be displayed relative to the image scan data (column 5, lines 13-16 of Cosman).
Claim(s) 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Rios, in view of Bangera, as applied to claim 1 above, further in view of Savitsky et al. (US11600201, hereafter “Savitsky”).
Regarding claim 12, Rios substantially discloses all the limitations of the claimed invention, but does not explicitly disclose further comprising a mount coupled to the ultrasound probe.
However, in the solving the same problem, Savitsky teaches further comprising a mount coupled to the ultrasound probe (FIGS. 6A-6B, see mount 150).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Rios with the mount coupled to the ultrasound probe as taught by Savitsky in order to provide a removable attachment to be used in training that allows the user to employ the same ultrasound probe as a motion sensing peripheral to navigate existing patient cases (column 3, lines 64-66, column 4, lines 1-5, of Savitsky).
Regarding claim 13, Rios, in view of Savitsky, substantially discloses all the limitations of the claimed invention, specifically, Savitsky discloses wherein the mount comprises a first interface configured to couple with the ultrasound probe (FIGS. 6A-6B, see probe 1-4 inside insert/interface 156 in carrier 152 of mount 150).
Regarding claim 14, Rios, in view of Savitsky, substantially discloses all the limitations of the claimed invention, specifically, Savitsky discloses wherein the mount is configured to provide kinematic constraint of six degrees of freedom (column 6, lines 21-43, the motion sensor/tracker employs 6-DOF, where each DOF refers to each axis of a 3-axis accelerometer and 3-axis gyro, which each respectively provide, 3-axes of position sensing and 3 axes of orientation sensing).
Regarding claim 15, Rios, in view of Savitsky, substantially discloses all the limitations of the claimed invention, specifically, Savitsky discloses wherein the mount is configured to provide repeatable and stable reattachment (column 1, lines 46, 49, column 2, lines , 1-4, column 5, lines 35-38, the motion sensor accessory/mount can be attached and removed from the probe, as the mount is not permanently attached and is removable, therefore, the mount is removably attached to the outside of the ultrasound probe) without recalibration of the ultrasound probe (column 4, lines 45-66, column 5, lines 1-30, the calibration is performed initially from data obtained from the tracker attached to the mount when the probe is inside the mount with respect to the location of the ultrasound system. Therefore, one of ordinary skill in the art would understand that the probe does not need to be recalibrated, as the location of the probe is dependent on the detected location of the tracker when the probe is inserted into the mount. Accordingly, as the location of the tracker on the mount is known, once the probe is inserted in the mount, the location thereof is congruent with the previously known/calibrated location of the tracker on the mount).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.S./Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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