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
The rejection under 35 U.S.C. 101 has been withdrawn in light of the amendment to the claims filed on 19 March 2026.
Drawings
The drawings were received on 19 March 2026. These drawings are acceptable and do not raise new matter issues.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-9, & 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
With regards to Claim 1, the claim now recites “applying a second trained computational model to predict a pose of the body and to track a position of an ultrasound imaging probe during an imaging protocol”; however, the instant specification fails to show possession of “applying a second trained computational model… to track a position of an ultrasound imaging probe during an imaging protocol” because the instant specification does not describe “the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention” as laid out in MPEP § 2163.02. More specifically,
Claim also now recites “such that only a portion of the body to be imaged during the ultrasound imaging method is not obscured”; however, the instant specification fails to show possession of only the body portion to be imaged via ultrasound is not obscured because the instant specification does not describe “the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention” as laid out in MPEP § 2163.02. More specifically, ¶ [0042, 0067] of the instant specification discloses “the unobscured areas are relevant to the body part being scanned and therefore the areas where the camera feed is collected during the imaging exam. The rest of the body remains obscured; hence, non-identifiable,” and ¶ [0076] discloses that “[T]he resulting image is one comprising essentially a body model representing the patient with only the relevant body part unmasked. Such a composite camera frame is stored alongside the DICOM images and the probe tracks, and a final representation of the probe pose projected onto the reconstructed patient body surface area.” While the instant specification discusses acquiring ultrasound imaging data form the unobscured areas, the instant specification does not limit the imaging to only the unobscured areas. Accordingly, the instant specification does not convey with reasonable clarity how one of ordinary skill in the art, as of the filing date sought, can show the inventor was in possession of “such that only a portion of the body to be imaged during the ultrasound imaging method is not obscured”. Therefore, Claim 1 fails to meet the written description requirement of 35 U.S.C. 112(a).
Claim 1 also
Dependent claims are rejected by virtue of their dependency to abovementioned claims.
With regards to Claim 23, the claim recites “automatically generating, from the identifying step, a composite image frame comprising the portion of the body at the position of the ultrasound imaging probe during the imaging protocol and one of the body surface map, a masked image, and a blurred image at the portion of the body to be obscured”; however, the instant specification fails to show possession of the composite image comprising the portion of the body… and one of the body surface map, a masked image, and a blurred image at the portion of the body to be obscured because the instant specification does not describe “the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention” as laid out in MPEP § 2163.02. Firstly, according to Ex parte Jung, 2016-008290 (PTAB Mar. 22, 2017), one of a, b, and c is interpreted as one of a, and one of b, and one of c. Secondly, the instant specification fails to support such a limitation. For example:
¶ [0019] discloses “images from cameras are used to create a digital contour map of the patient's body surface area, and to mask and blur patient's identity and body parts that are excluded from the imaging protocols”;
¶ [0021] discloses that “blurring and other masking techniques are applied to preserve patients' privacy” in camera images; and
¶ [0053] discloses “The de-identification is done by masking and blurring all body parts that are not included in the imaging protocol” and “The areas that remain unmasked/unblurred may be the areas under imaging investigation” (emphasis added);
¶ [0076], cited by Applicant for having support for the above claim limitations, discloses “The resulting image is one comprising essentially a body model representing the patient with only the relevant body part unmasked”; and
¶ [0076 & 0083] mention “composite image” but fail to explicitly or inherently define the scope of “composite image.”
However, the instant specification fails to equate the surface map to the body model; therefore, there is no clear disclaimer that the surface map falls within the scope of body model or vice versa. Moreover, there is no disclosure regarding the scope of “composite image.” At most, one of ordinary skill in the art can glean from ¶ [0076] that the composite image comprises “essentially a body model representing the patient with only the relevant body part unmasked”, but there is no mention of a masked image or a blurred image, let alone a composite image comprising one of the body surface map, one of a masked image, and one of a blurred image. Accordingly, the instant specification does not convey with reasonable clarity how one of ordinary skill in the art, as of the filing date sought, can show the inventor was in possession of “a composite image frame comprising the portion of the body at the position of the ultrasound imaging probe during the imaging protocol and one of the body surface map, a masked image, and a blurred image at the portion of the body to be obscured.” Therefore, Claim 23 fails to meet the written description requirement of 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 112(b)
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.
Claim 23 is 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.
In particular, Claim 23 recites “a composite image frame comprising the portion of the body at the position of the ultrasound imaging probe during the imaging protocol and one of the body surface map, a masked image, and a blurred image at the portion of the body to be obscured”; however, it is unclear the image frame is composited to include the position of the ultrasound imaging probe along with one of the body surface map, one of a masked image, and one of a blurred image at the portion of the body to be obscured as the instant specification fails to further describe such an embodiment.
Furthermore, it is unclear if the if just one of the blurred image is “at the portion of the body to be obscured” or if the portion of the body at the position of the ultrasound imaging probe OR one of the body surface map OR one of the masked image is also “at the portion of the body to be obscured.”
For the purposes of compact prosecution, the limitation will be interpreted as “a composite image frame comprising the portion of the body at the position of the ultrasound imaging probe during the imaging protocol and, at the portion of the body to be obscured, one of the body surface map, a masked image, or a blurred image at the portion of the body to be obscured.” It should be noted that such an interpretation has not been evaluated for compliance with the written description requirement under 35 U.S.C. 112(a).
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1, 3-8 & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Shoudy et al. (US PGPUB 20200375546; hereinafter "Shoudy") in further view of Simhadri et al. (see IDS of 20 June 2024; hereinafter "Simhadri").
With regards to Claim 1, Shoudy discloses a method of performing ultrasound imaging, the method comprising:
receiving images from a camera (image device 12 generates 3D surface map based on sensor data {i.e. images}; see Shoudy ¶ [0044]);
reconstructing a body surface map from the images from the camera (image device 12 generates 3D surface map based on sensor data {i.e. images}; see Shoudy ¶ [0044]);
applying a (fuse the pose of the patient 22 with the 3D surface map of the patient 22, the pose may be represented by adjoining anatomical reference points, wherein reference points include center of mass of the head, the neck, the shoulders, the elbows, the wrists, the chest, the hips, the knees, the ankles, and/or the like, i.e. parameters with identify shape/body type of the patient; see Shoudy ¶ [0045]; the controller 24 may use deep learning techniques to establish the one or more anatomical reference points associated with the patient 22 or the patient pose mesh associated with the patient 22 {i.e. the fused surface map is based on a machine learning model}; see Shoudy ¶ [0056, 0082] & FIG. 7);
applying a (estimate/predict pose of the patient with deep-learning techniques pose-estimation or pose-determination technique; see Shoudy ¶ [0044]; it should be appreciated that the pose-estimation deep learning technique would not be capable of identifying the anatomical reference points and, therefore, amounts to a separate deep learning model; see also Shoudy ¶ [0082]) and to track a position of an ultrasound imaging probe during an imaging protocol (use computer vision {i.e. computational model} to localize the imaging hardware via pattern matching of a known 3D shape of the imaging hardware with RGB-D data from the mobile device 210 or generated 3D surface data; see Shoudy ¶ [0084]); and
identifying, on the body surface map and with the predicted body type and the predicted pose, (use computer vision {i.e. computational model} to localize the imaging hardware via pattern matching of a known 3D shape of the imaging hardware with RGB-D data from the mobile device 210 or generated 3D surface data; see Shoudy ¶ [0084]; If the controller 224 determines that the ultrasound probe is not in the desired position and/or orientation 322, the controller 224 may provide guidance to the operator to move the ultrasound probe the desired position and/or orientation 322 based on the common coordinate system established via the 3D surface map; see Shoudy ¶ [0084-0085]), .
While Shoudy discloses various deep learning techniques {e.g. Deep Pose ¶ [0038], pose estimation ¶ [0044, 0082], 3D anatomical reference points extraction ¶ [0047], patient pose mesh ¶ [0056]}, as detailed above, it appears that Shoudy may be silent to a first and second trained computational model. However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shoudy to provide at least a first and second computational model. Doing so would amount to combining prior art elements according to known methods to yield predictable results, i.e. Shoudy teaches of various deep learning techniques, therefore, one of ordinary skill in the art would recognize that utilizing different deep learning models for each task.
While modified Shoudy discloses identifying the head as an anatomical reference (see ¶ [0045]), it appears that Shoudy may be silent to identifying, on the body surface map, a portion of the body to be obscured. However, commonly held Simhadri teaches of systems and techniques that facilitate real-time and/or offline de-identification of facial regions from regular and/or occluded color video streams obtained during diagnostic medical procedures such as ultrasound procedures (see Simhadri Abstract & ¶ [0032]). In particular, Simhadri teaches of identifying, on the body surface map, a portion of the body to be obscured (estimating a pose of the person within a bounding box, identify anatomical keypoints including those in the facial region to form a heatmap, and anonymize pixels {via blurring or blocking pixels} in the frame that correspond to the face or facial region of the person; see Simhadri ¶ [0028]), and such that only a portion of the body to be imaged during the ultrasound imaging method is not obscured (in various embodiments, the automated face anonymization system 102 can perform anonymization/de-identification on any suitable, desired, and/or specified anatomical region of interest that can be set/selected by an operator/technologist (e.g., the subject claimed innovation can be implemented to anonymize regions other than face or facial regions filmed during diagnostic/therapeutic medical procedures, such as other identifiable body characteristics, clothing logos/messages, and so on)”; see Simhadri ¶ [0051]; it should be appreciated that the head imaging embodiment of FIGS. 16-17 along with the complementary teachings of ultrasound procedures (as cited Simhadri ¶ [0032]) and the complementary teaching that areas other than the exampled head imaging can be obscured, accordingly, if clothing message is the only identifying characteristic then it will be obscured while imaging inspection is performed elsewhere).
Simhadri also teaches that deep learning techniques are trained using supervised learning (see Simhadri ¶ [0025 & 0038-0039]).
Modified Shoudy and Simhadri are both considered to be analogous to the claimed invention because they are in the same field of camera based patient tracking during medical imaging procedures. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shoudy to incorporate the above teachings of Simhadri to provide at least the struck-through limitations above. Doing so would aid in protecting patient privacy in compliance with laws and regulations (see Simhadri ¶ [0025]).
With regards to Claim 31, modified Shoudy teaches of further comprising applying the second trained computational model to predict an orientation of the ultrasound imaging probe relative to the predicted pose of the body (use computer vision {i.e. computational model} to localize the imaging hardware via pattern matching of a known 3D shape of the imaging hardware with RGB-D data from the mobile device 210 or generated 3D surface data within a shared coordinate system with the 3D surface map; see Shoudy ¶ [0084]).
With regards to Claim 43, modified Shoudy teaches of wherein applying the second computational model further comprises identifying anatomical parts (fuse the pose of the patient 22 with the 3D surface map of the patient 22, the pose may be represented by adjoining anatomical reference points, wherein reference points include center of mass of the head, the neck, the shoulders, the elbows, the wrists, the chest, the hips, the knees, the ankles, and/or the like, i.e. parameters with identify shape/body type of the patient; see Shoudy ¶ [0045]).
With regards to Claim 51, modified Shoudy teaches of further comprising coupling the tracked position of the ultrasound imaging probe to the predicted body surface map, and saving the tracked position relative to the modeled body surface map (If the controller 224 determines that the ultrasound probe is not in the desired position and/or orientation 322, the controller 224 may provide guidance to the operator to move the ultrasound probe the desired position and/or orientation 322 based on the common coordinate system established via the 3D surface map; see Shoudy ¶ [0084-0085]).
With regards to Claim 61, modified Shoudy teaches of wherein the applying the first computational model to predict the body type further comprises matching the body surface map to a matching body type (fuse the pose of the patient 22 with the 3D surface map of the patient 22, the pose may be represented by adjoining anatomical reference points, wherein reference points include center of mass of the head, the neck, the shoulders, the elbows, the wrists, the chest, the hips, the knees, the ankles, and/or the like, i.e. parameters with identify shape/body type of the patient; see Shoudy ¶ [0045]; the controller 24 may use deep learning techniques to establish the one or more anatomical reference points associated with the patient 22 or the patient pose mesh associated with the patient 22 {i.e. the fused surface map is based on a machine learning model}; see Shoudy ¶ [0056, 0082]).
With regards to Claim 71, modified Shoudy teaches of wherein the applying the second trained computational model to predict an orientation of the ultrasound imaging probe further comprises predicting movement of the ultrasound imaging probe based on a plurality of video frames (use computer vision to localize the imaging hardware via pattern matching of a known 3D shape of the imaging hardware with RGB-D data from the mobile device 210 or generated 3D surface data; see Shoudy ¶ [0084]; i.e. probe is localized in RGB-D data is based on image frame data).
With regards to Claim 86, modified Shoudy teaches of wherein the applying the first trained computational model further comprises providing ground truth data to the first trained computational model to predict the body surface map (wherein the deep learning models are trained via supervised learning; see Simhadri ¶ [0039]).
With regards to Claim 231, modified Shoudy teaches of further comprising:
automatically generating, from the identifying step, a composite image frame comprising the portion of the body at the position of the ultrasound imaging probe during the imaging protocol and one of the body surface map, a masked image, and a blurred image at the portion of the body to be obscured (FIG. 7 of Shoudy clearly illustrates the 3D surface map with probe 322 illustrated, i.e. composite image; and Simhadri, as detailed above, teaches of anonymization of the facial region via blurring or blocking pixels).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shoudy in view of Simhadri, as applied to Claim 8 above, and in further view of Piccirilli et al. (see the IDS of 20 June 2024; hereinafter " Piccirilli").
With regards to Claim 98, it appears that neither Shoudy nor Simhadri, alone or in combination, may be silent to wherein the ground truth data comprise non-imaging data. However, Piccirilli, which is analogous as admitted by Applicant in the IDS of 20 June 2024, teaches of training machine learning computer vision algorithms {i.e. deep learning algorithms} for analyzing who body surface area to be used in different scenarios, such as in an Emergency Room for burn area detection (see Piccirilli Abstract & pg. 6, ¶ 2). In particular, Piccirilli teaches that the training data includes mesh data {i.e. non-image data} that that captures variations in body shape and body size due to gender, race, and age (see Piccirilli pg. 4, ¶ 2).
Modified Shoudy and Piccirilli are both considered to be analogous to the claimed invention as admitted by Applicant. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Shoudy to incorporate the above teachings of Piccirilli to provide at least the ground truth data comprise non-imaging data. Doing so would aid in capturing variations in body shape and body size due to gender, race, and age (see Piccirilli pg. 4, ¶ 2).
Response to Arguments
Applicant's arguments filed 19 March 2026 have been fully considered but they are not persuasive.
In particular, Applicant contends that Shoudy in view of Simhadri cannot obviate the claims as amended. In support, Applicant argues that “Simhadri et al. fail to disclose or suggest any obscuring of body portions that are not to be imaged. Instead, Simhadri et al. contemplate just the obscuring of the face; all other body portions are imaged in the Simhadri et al. teachings. This teaching fails to contemplate an identifying where only the portions to be imaged during the ultrasound imaging are actually imaged.” The Office disagrees. Simhadri teaches that “In various embodiments, the automated face anonymization system 102 can perform anonymization/de-identification on any suitable, desired, and/or specified anatomical region of interest that can be set/selected by an operator/technologist (e.g., the subject claimed innovation can be implemented to anonymize regions other than face or facial regions filmed during diagnostic/therapeutic medical procedures, such as other identifiable body characteristics, clothing logos/messages, and so on).” Therefore, the head imaging embodiment of FIGS. 16-17 along with the complementary teachings of an ultrasound procedures (as cited Simhadri ¶ [0032]) and the complementary teaching that areas other than the exampled head imaging can be obscured.
With regards to dependent claims, Applicant relies on the virtue of their dependency upon abovementioned independent claims to argue novelty. Accordingly, said argument is not persuasive for at least the same reasons as amended Claim 1 as detailed above.
It should also be appreciated that Park et al. (WO-2020204645-A1 as cited in the IDS of 20 June 2024) teaches of providing a guide image for guiding an ultrasound examination position in addition to an ultrasound image of a patient's body, and anonymizing the guide image such that the user can recognize the current ultrasound examination location through the guide image and proceed with the ultrasound examination while patient is rendered anonymous. Park et al. also teaches in FIG. 3B which clearly illustrates the a body portion to be imaged, via guidance image, that is not obscured and only the portion not image (facial region) is obscured.
Similarly, Dubin et al. (US PGPUB 20170112439) teaches of capturing, with a camera, an orientation image which guides a user to execute a measurement {e.g. ultrasound measurement} at a correct location (see Dubin et al. ¶ [0078 & 0100]); anonymizing a selected body area in the orientation image while keeping the area around the measurement system coherent such that the position of the sensor and its orientation is clear (see Dubin et al. ¶ [0240]).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571)272-6402. The examiner can normally be reached M-F 8:00 am - 4:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith M. Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798
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