DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of species C in the reply filed on 06/04/2026 is acknowledged.
Claim 6 and 11-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/04/2026. Examiner notes that while applicant notes that claims 1-3 and 13-20 are presented for application, that claims 4-5 and 7-10 are considered to read on the elected invention due to the breadth of “based on”. Claims 4-5 and 7-10 are therefore examined accordingly.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-10, and 13-20 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.
Claims 1 and 20 recite the limitation “specify/specifying a scanning progress status of the ultrasound probe for the organ by performing registration between the acquired three-dimensional ultrasound image and the selected one organ template”. It is unclear how specifying a scanning progress status is done by performing registration. For example, is the registration or result thereof the nature of the specifying and merely registering the image to the template is considered to specify a scanning progress status or is the specifying a scanning progress status a separate element which uses a result of the registration or is based on the registration. For examination purposes, it has been interpreted that the registration may be the scanning progress status or that the scanning progress status is based on or uses the registration, however, clarification is required.
Claim 14 recites the limitation “calculate an evaluation value by obtaining a weighted average of the calculated degree of fitness and the calculated degree of similarity”. Examiner notes that the limitation is unclear first as to whether the limitation intends to mean obtaining a weighted average of the calculated degree of fitness and obtaining the calculated degree of similarity or if the limitation is intended to mean a weighted average between or of both the calculated degree of fitness and the calculated degree of similarity. This is further unclear due to the fact that the claim previously recites a degree of fitness… and a degree of similarity.. for each of the plurality of organ templates, thus making unclear which degree of fitness and degree of similarity the claim is referring to. For examination purposes, it has been interpreted that the processor calculates an evaluation value for each of the plurality of organ templates by obtaining a weighted average between the corresponding calculated degree of fitness and corresponding calculated degree of similarity, however, clarification is required.
Claim 16 recites the limitation “display the scanning progress status of the ultrasound probe on the monitor”. It is unclear if the display is the same as the output or if this is a different/distinct function. In other words, it is noted that displaying a scanning progress status may be considered the same as outputting the scanning progress status, thus making unclear if the limitation is attempting to further define the output recited in claim 1 to be a display or if this is a different/distinct display. For examination purposes, it has been interpreted to mean either the same or different, however, clarification is required.
Claim 18 recites the limitation “output the quantified scanning progress status”. It is first unclear which quantified scanning progress status (i.e. for which of the plurality of sections) the limitation is referring to. It is further unclear if the quantified scanning progress status is the same or different from the previously recited scanning progress status. In other words, it is unclear if the claim is attempting to further define the scanning progress status of claim 1 to be a quantified scanning progress status or if this is a different status. For examination purposes, it has been interpreted o mean either the same or different, however, clarification is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-10, and 13-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea without significantly more.
In a test for patent subject matter eligibility, the claims pass Step 1 (see 2019 Revised Patent Subject Matter Eligibility), as they are related to a process, machine, manufacture, or composition of matter.
When assessed under Step2A, Prong I, Independent claims 1 and 20 are found to recite a judicial exception (i.e. abstract idea). In this instance, claims 1 and 20 recite the limitation “select/ing one organ template from among the plurality of organ templates in accordance with a body size of the subject” and “specify/specifying a scanning progress status of the ultrasound probe for the organ by performing registration between the three-dimensional ultrasound image and the one organ template” and “output/outputting the specified scanning progress status”. The cited limitations, under their broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of selecting, specifying, and outputting which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a person could reasonably select an organ template via observation/evaluation, specify a scanning progress by performing a registration via observation/evaluation, and output the specified scanning progress status via thought. Examiner notes that with the exception of generic computer-implemented steps (e.g. a processor recited in claim 1), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the cited limitation(s) recites a judicial exception (MPEP 2106.04(a)) and the claim must be reviewed under Step 2A, Prong II to determine patent eligibility.
Step 2A, Prong II determines whether any claim recites an additional element that integrates the judicial exception into a practical application. Independent claims recites the following additional element(s):
A template memory in which a plurality of organ templates are stored (claim 1)
Acquire/acquiring a three-dimensional ultrasound image of the organ by transmitting and receiving an ultrasound beam using the ultrasound probe
A processor (claim 1)
Storing a plurality of organ templates in a template memory (claim 20)
Performing registration between the acquired three-dimensional ultrasound image and the selected one organ template
Output/outputting the specified scanning progress.
The additional element(s) in the cited independent claim(s) are not found to integrate the judicial exception into a practical application. In this case, a template memory and processor are seen as merely generic components of an medical imaging system and storing templates therein is seen as merely insignificant pre-solution activity of data storing. Acquiring a three dimensional ultrasound images is seen as merely insignificant pre-solution activity of data gathering. Performing registration and outputting are additionally/alternatively considered additional elements amount to merely insignificant extra-solution activity of data registration and outputting of results/data. These elements are seen as adding insignificant extra-solution activity to the judicial exception. They do no more than link the judicial exception to a particular technological environment or field of use. Therefore, under step 2A Prong II the Judicial exception is not integrated into a practical application by additional elements of independent claims 1 and 20 and the claims must be reviewed under Step 2B to determine patent eligibility.
Step 2B determines where a claim amounts to significantly more.
The additional element(s) listed above do not amount to significantly more than the judicial exception. Additionally there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. Therefore, under Step 2B in a test for patent subject matter eligibility, the judicial exception of the independent claim(s) do not amount to significantly more and the independent claim(s) remain patent ineligible.
Dependent claims 2-5, 7-10, and 13-19 further limit the abstract idea of independent claim 1. When analyzed as a whole, these claims are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed towards an abstract idea and do not sufficiently integrate the subject matter into a practical application or recite elements which constitute significantly more than the abstract ideas identified. The dependent claims are directed toward additional elements which encompass abstract ideas
In this instance, dependent claims recite the following limitations:
Calculate a degree of fitness with respect to the subject information
Calculate a degree of similarity with respect ot the three-dimensional ultrasound image for each of the plurality of organ templates
Calculate an evaluation value by obtaining a weighted average of the calculated degree of fitness and the calculated degree of similarity
Select an organ template having the highest evaluation value as the organ template
Narrow down a plurality of candidate templates from among the plurality of organ templates based on the subject information
Calculate a degree of similarity with respect to the three-dimensional ultrasound image for each of the plurality of narrowed-down candidate templates
Select a candidate template having a highest degree of similarity as the one organ template.
Divide the organ into a plurality of sections
Quantify the scanning progress status of the ultrasound probe in each of the plurality of sections;
Output the quantified scanning progress
Output a section in which further scanning using the ultrasound probe is recommended.
The cited limitation(s), under their broadest reasonable interpretation, encompass mental processes (i.e. abstract idea) which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a human could reasonably calculate a degree of fitness/similarity, and calculate an evaluation value, narrow down a plurality of candidate templates, select, divide an organ into a plurality of sections, quantify the scanning progress and output. Examiner notes that with the exception of generic computer-implemented steps (e.g. the processor), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the claimed limitation is considered to be directed towards a judicial exception (MPEP 2106.04(a)).
Under Step 2A, Prong II for dependent claims 2-5, 7-10, and 13-19 present additional elements which only further narrow the judicial exceptions (e.g. claims 2-3 which further narrow the nature of the plurality of organ templates, claims 4-5, 9-10, and 13 which further narrow the natures of the selection, claims 7-8 which further narrow the nature of the subject information, claim 16 which further introduces a generic monitor and displaying the scanning progress status amounting to merely insignificant post-solution activity of data display) and provide no additional element which are found to integrate the judicial exception into a practical application.
These dependent claims include no additional claims that are sufficient to amount to significantly more than the judicial exception. Additionally, there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. As discussed above with respect to integration of the abstract idea into a practical application, the additional claims do not provide any additional elements that would amount to significantly more than the judicial exception. Under Step 2B, these claims are not patent eligible.
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.
Claims 1-5, 7-10, 13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Caluser (US 20190000318 A1), hereinafter Caluser in view of WIPO Reicher et al. (WO 2024102765 A1), hereinafter Reicher.
Regarding claims 1 and 20,
Caluser teaches an ultrasound diagnostic apparatus (at least fig. 1 (10 and/or 20) and corresponding dsiclo9sure in at least [0038]) for observing an organ of a subject by performing scanning using an ultrasound probe (at least fig. 1 (34) and corresponding disclosure in at least [0038]), the ultrasound diagnostic apparatus comprising:
A template memory (at least fig. 1 (39) and corresponding disclosure in at least [0039]) in which an organ template is stored ([0089] which discloses accessing the reference state model. Examiner notes that accessing/use of a reference state model requires storage of the reference state model at least temporarily in a template memory); and
A processor (at least fig. 1 (21) and corresponding disclosure in at [0039]) configured to:
Acquire a three-dimensional ultrasound image of the organ by transmitting and receiving an ultrasound beam using the ultrasound probe([0046] which discloses processor 21 of ultrasound machine 22 includes an image reconstruction module 29, which receives ultrasound data acquired via ultrasound probe 34 and generates or reconstructs 2D or 3D ultrasound images therefrom);
Obtain one organ template in accordance with a body size of the subject ([0089] which discloses technique 182 begins by accessing the reference state model at step 184. [0062] which discloses the reference state model can be obtained. Alternatively, the reference state model can be obtained with any imaging modality and used with medical images acquired from the same or different modality. In one embodiment, the supine or prone MRI images can be used to build the reference state model. Anatomical landmarks like nipple and sternum or chest can be easily identified in the MRI images and used to build the reference state model. Additional surface markers, 108, which can be detected in the MRI images can be used to generate the reference state model. The MRI detectable surface markers can be multimodality type of markers, which can be also detected in ultrasound images or with a handheld imaging probe mounted skin surface camera, 2D or 3D mammographic images or any other imaging modality. A reference state model can be obtained with prone MRI images where compression plates are used to position the breast and to allow the mapping of skin surface markers or skin pattern anatomical markers. Any other 3D images, like CT, PET, SPECT can be used to generate the reference state model. A second set of images obtained with a different deformation from the reference state, can be projected in the reference state model, as described in detail below);
Specify a scanning progress status of the ultrasound probe for the organ by performing registration between the three-dimensional ultrasound image and the one organ template ([0089] which discloses technique 182 projects the pixels from the medical images to the reference state model at step 190 and measures the distance between neighboring pixels or voxels within the reference state model at step 192. see also [0083] which discloses multiple ultrasound frames or corresponding reconstructed volume or volumes obtained with TDMD 20, can be registered with and represented within reference state model and [0092] which discloses technique 182 determines scanning completeness by mapping all of the pixels from the acquired image frames to the reference state model (i.e., mapping the entire volume of the reference state model); and
Output the specified scanning progress status ([0090] which discloses when the distance between pixels falls below a set threshold 196, the condition to satisfy complete scanning is met and the voxels with corresponding volume can be marked in the reference state model. For the voxels not meeting the set threshold or for the regions with no voxels 198, the corresponding volume can be marked as incomplete scanned in the reference state model and the user can be guided to rescan the incomplete region(s) to acquire additional medical images at step 188 and Once the location of the area(s), containing insufficient or suboptimal image data is determined, TDMD 20 may automatically and instantly generate an alert that prompts an operator to rescan the area(s) and When the condition to complete the whole breast volume or a determined partial volume scan is satisfied, a signal can be generated).
While Caluser teaches in [0093] that one or more reference state models may be used to cross-correlated image data acquired during two or more temporally distinct examination of the same patient and that the reference state model may be obtained with any imaging modality and building/generating the reference state model from supine or prone MRI images in [0062], it is not explicitly clear if the template memory has a plurality of organ templates stored and the processor is configured to select one organ template from among the plurality of organ templates, therefore, caluser fails to explicitly teach the template memory in which a plurality of organ templates are stored and the processor configured to select one organ template from among the plurality of organ templates in accordance with a body size of the subject.
Reicher, in a similar field of endeavor involving medical imaging, teaches a template memory (at least fig. 1 (130) and corresponding disclosure in at least [22]) in which a plurality of organ templates (at least fig. 1 (131) and corresponding disclosure in at least [22]) are stored and a processor configured to select one organ template from among the plurality of organ templates in accordance with a body size of the subject (at least fig. 2 (203) and corresponding disclosure in at least [46] and at least fig. 2 (209) and corresponding disclosure in at least [53]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Caluser to include a template memory and selecting one organ template from among the plurality of organ templates in accordance with a body size of the subject as taught by Reicher in order to provide selecting a patient specific model which may already be available in the template memory without requiring new generation/creation of a 3D anatomical model from image data, thereby reducing processing requirements during the procedure when such a plurality of organ templates are already stored. Furthermore, such a modification would allow for registration of the patient image to a most similar template image to provide quantifiable measures of patient conditions, to improve medical diagnosing and/or facilitate generating medical reports (Reicher [7]). Furthermore, such a modification amounts to merely a simple substitution of one known reference state model accessing means for another yielding predictable results with respect to patient specific model retrieval thereby rendering the claims obvious (MPEP 2143).
The modified system would perform the method of claim 20 having corresponding method steps.
Regarding claim 2,
Caluser, as modified, teaches the elements of claim 1 as previously stated. Caluser further teaches wherein the organ template consists of three-dimensional data representing a contour of the organ in accordance with the body size of the subject (at least fig. 4 (136) and corresponding dsiclosrue in at least [0048] and [0050] which discloses The volume of the reference state model is defined by breast skin surface, referred to herein as the anterior or deformed surface, the chest wall surface, referred to herein as the posterior surface, or non deformed surface, and the breast surface contour line, which refers to the outline of the surface area of the breast tissue at the chest wall and represents the bottom surface of the breast. In other words, the breast surface contour line, with the area within it, which is also the posterior surface or the non deformed surface, is the boundary between breast tissue and the chest wall structures underneath the breast.)
Reicher further teaches wherein each of the plurality of organ templates consists of three-dimensional data representing a contour of the organ in accordance with the body size of the subject ([22] which discloses a template 131 may comprise a 3D representation of an anatomical region, such as in a 3D imaging volume that may be used by a reconstruction algorithm to generate 2D slices of any plane of the 3D imaging volume. Templates 131 may have been generated according to one or more imaging modalities, such as spectroscopy. X-ray, ultrasound, MRI, CT, or the like. See also [7] which discloses such as borders of anatomical regions and/or anatomical information associated with those regions, can be displayed in combination with a patient image, such as overlaid on a patient image)
Examiner notes that in the modified system the plurality of organ templates would consist of three-dimensional data representing a contour of the organ in the same manner disclosed with respect to the reference state model of Caluser and/or Reicher.
Regarding claim 3,
Caluser, as modified, teaches the elements of claim 1 as previously stated. Caluser further teaches wherein the organ template consists of three-dimensional data representing a contour of the organ and an internal structure of the organ in accordance with the body size of the subject (see at least fig. 4 (136) and corresponding disclosure in at least [0048]. See also [0062] which discloses alternatively, the reference state model can be obtained with any imaging modality and used with medical images acquired from the same or different modality. In one embodiment, the supine or prone MRI images can be used to build the reference state model. Anatomical landmarks like nipple and sternum or chest can be easily identified in the MRI images and used to build the reference state model. Additional surface markers, 108, which can be detected in the MRI images can be used to generate the reference state model. The MRI detectable surface markers can be multimodality type of markers, which can be also detected in ultrasound images or with a handheld imaging probe mounted skin surface camera, 2D or 3D mammographic images or any other imaging modality. A reference state model can be obtained with prone MRI images where compression plates are used to position the breast and to allow the mapping of skin surface markers or skin pattern anatomical markers. Any other 3D images, like CT, PET, SPECT can be used to generate the reference state model. A second set of images obtained with a different deformation from the reference state, can be projected in the reference state model, as described in detail below)
Reicher further teaches wherein each of the plurality of organ templates consists of three-dimensional data representing a contour of the organ and an internal structure of the organ in accordance with the body size of the subject ([22] which discloses a template 131 may comprise a 3D representation of an anatomical region, such as in a 3D imaging volume that may be used by a reconstruction algorithm to generate 2D slices of any plane of the 3D imaging volume. Templates 131 may have been generated according to one or more imaging modalities, such as spectroscopy. X-ray, ultrasound, MRI, CT, or the like. See also [7] which discloses such as borders of anatomical regions and/or anatomical information associated with those regions, can be displayed in combination with a patient image, such as overlaid on a patient image)
Examiner notes that in the modified system the plurality of organ templates would consist of three-dimensional data representing a contour of the organ and an internal structure in the same manner disclosed with respect to the reference state model of Caluser and/or Reicher.
Regarding claims 4 and 5,
Caluser, as modified, teaches the elements of claims 1 and 2 as previously stated.
Reicher, as applied to claims 1 and 2 above, further teaches wherein the processor is configured to select the one organ template based on subject information related to the body size of the subject
Regarding claim 7,
Caluser, as modified, teaches the elements of claim 4 as previously stated. Reicher, as applied to claim 4 above, further teaches wherein the subject information includes at least height, weight, or age of the subject ([46] which discloses the computing device can select a template based on a patient profile. As noted above, a patient profile can include one or more of patient demographic information, patient medical history, historical templates registered to the patient’s image(s), imaging modality used to generate patient images, or the like. The computing device can select a template based on identifying template metadata that corresponds to a patient profile. As an example, the computing device may select a template having demographics metadata that matches the patient demographics of the patient profile and [23] which discloses demographics can include age, weight, height, sex, race, or the like.).
Regarding claim 8,
Caluser, as modified, teaches the elements of claim 7 as previously stated. Reicher, as applied to claim 7 above, further teaches wherein the subject information includes gender of the subject ([23] which discloses demographics can include age, weight, height, sex, race, or the like).
Regarding claim 9,
Caluser, as modified, teaches the elements of claim 4 as previously stated. Reicher further teaches wherein the processor is configured to select the one organ template based on the subject information designated in a patient profiled ([27] A patient profile 138 may include information associated with a patient associated with one or more of the patient images 136. A patient profile 138 may include information indicating one or more characteristics of a patient. For example, a patient profile 138 may include demographic information of a patient, such as age, weight, height, sex, race, or the like. Examiner notes that a person having ordinary skill in the art would have recognized the demographic information of the patient included in a patient profiled 138 is necessarily designated by a user of the system).
Regarding claim 10,
Caluser, as modified, teaches the elements of claim 1 as previously stated. Reicher, as applied to claim 1 above, further teaches the processor is configured to select the one organ template based on a three-dimensional image ([53] which discloses the computing device can determine which template matches most closely to the patient image by analyzing differences between the template and a registered template generated from the registration, differences between the registered template and the patient image, and/or differences between the template and the patient image, such as with one or more difference arrays described at block 211).
Regarding claim 13,
Caluser, as modified, teaches the elements of claim 1 as previously stated.
Reicher, as applied to claim 1 above ,further teaches wherein the processor is configured to select the one organ template based on subject information related to the body size of the subject ([46] which discloses the computing device can select a template based on a patient profile. As noted above, a patient profile can include one or more of patient demographic information, patient medical history, historical templates registered to the patient’s image(s), imaging modality used to generate patient images, or the like. The computing device can select a template based on identifying template metadata that corresponds to a patient profile. As an example, the computing device may select a template having demographics metadata that matches the patient demographics of the patient profile and [0053] which discloses at block 209 the computing device can optionally register additional templates to the patient image, for example by performing any of the operations associated with blocks 203-207. Examiner notes that in repetitively performing step 203 to register template images, that the candidate templates are narrowed down among the plurality of organ templates (i.e. such that the candidate templates are templates which match the demographics as disclosed in [46])
And a three-dimensional patient image ([0053] which discloses the computing device can determine which template matches most closely to the patient image by analyzing differences between the template and a registered template generated from the registration, differences between the registered template and the patient image, and/or differences between the template and the patient image, such as with one or more difference arrays described at block 211).
Regarding claim 15,
Caluser, as modified, teaches the elements of claim 1 as previously stated.
Reicher, as applied to claim 13 above, further teaches wherein the processor is configured to: narrow down a plurality of candidate templates from among the plurality of organ templates based on the subject information ([46] which discloses the computing device can select a template based on a patient profile. As noted above, a patient profile can include one or more of patient demographic information, patient medical history, historical templates registered to the patient’s image(s), imaging modality used to generate patient images, or the like. The computing device can select a template based on identifying template metadata that corresponds to a patient profile. As an example, the computing device may select a template having demographics metadata that matches the patient demographics of the patient profile and [0053] which discloses at block 209 the computing device can optionally register additional templates to the patient image, for example by performing any of the operations associated with blocks 203-207. Examiner notes that in repetitively performing step 203 to register template images, that the candidate templates are narrowed down among the plurality of organ templates (i.e. such that the candidate templates are templates which match the demographics as disclosed in [46])
Calculate a degree of similarity with respect to the three-dimensional ultrasound image for each of the plurality of narrowed-down candidate templates ([53] which discloses the computing device can determine which template matches most closely to the patient image by analyzing differences between the template and a registered template generated from the registration, differences between the registered template and the patient image, and/or differences between the template and the patient image, such as with one or more difference arrays described at block 211); and
Select a candidate template having a highest degree of similarity as the one organ template ([0053] which discloses the computing device can determine which template matches most closely to the patient image by analyzing differences between the template and a registered template generated from the registration, differences between the registered template and the patient image, and/or differences between the template and the patient image, such as with one or more difference arrays described at block 211).
Regarding claim 16,
Caluser further teaches a monitor (at least fig. 1 (38) and corresponding disclosure in at least [0039]), wherein the processor is configured to display the scanning progress status of the ultrasound probe on the monitor ([0091] which discloses a completeness map 200, illustrated in FIG. 14, is generated and displayed at step 202 to indicate regions 204 where the completeness condition between voxels is satisfied and regions 206 where the completeness condition is not satisfied relative to the reference state model).
Regarding claim 17,
Caluser further teaches wherein the processor is configured to display a region that has been scanned using the ultrasound probe (at least fig. 17 (205) and corresponding disclosure in at least [0091]) or a region that has not yet been scanned using the ultrasound probe on the monitor as the scanning progress status ([0090] which discloses For the voxels not meeting the set threshold or for the regions with no voxels 198, the corresponding volume can be marked as incomplete scanned in the reference state model and the user can be guided to rescan the incomplete region(s) to acquire additional medical images at step 188.).
Regarding claim 18,
Caluser further teaches wherein the processor is configured to: divide the organ into a plurality of sections; quantify the scanning progress status of the ultrasound probe in each of the plurality of sections; and output the quantified scanning progress status ([0090] which discloses when the distance between pixels falls below a set threshold 196, the condition to satisfy complete scanning is met and the voxels with corresponding volume can be marked in the reference state model. For the voxels not meeting the set threshold or for the regions with no voxels 198, the corresponding volume can be marked as incomplete scanned in the reference state model and the user can be guided to rescan the incomplete region(s) to acquire additional medical images at step 188. Once the location of the area(s), containing insufficient or suboptimal image data is determined, TDMD 20 may automatically and instantly generate an alert that prompts an operator to rescan the area(s). Alternatively, alerts may be saved with the acquired image frames for later review. When the condition to complete the whole breast volume or a determined partial volume scan is satisfied, a signal can be generated).
Regarding claim 19,
Caluser further teaches wherein the processor is configured to output a section in which further scanning using the ultrasound probe is recommended among the plurality of sections based on the quantified scanning progress statuses of the ultrasound probe in the plurality of sections ([0090] which discloses Once the location of the area(s), containing insufficient or suboptimal image data is determined, TDMD 20 may automatically and instantly generate an alert that prompts an operator to rescan the areas).
Double Patenting
Claims 1-5, 7-10, and 13-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18955534 in view of Reicher.
This is a provisional nonstatutory double patenting rejection.
Regarding instant claims 1 and 20,
Reference claims 1 and 20 recite all of the elements of instant claim 1 other than the selection of the organ template being “in accordance with a body size of the subject” as reference claim 1 selects the organ template in accordance with a posture.
Reicher, in a similar field of endeavor involving template selection, teaches selecting an organ template from a plurality of organ templates in accordance with a body size of the subject ([46] which discloses As noted above, template metadata can include one or more of demographic information of subjects associated with the templates, imaging modality used to generate a template, physiological conditions, or the like. The computing device can select a template based on a patient profile. As noted above, a patient profile can include one or more of patient demographic information, patient medical history, historical templates registered to the patient’s image(s), imaging modality used to generate patient images, or the like. The computing device can select a template based on identifying template metadata that corresponds to a patient profile. As an example, the computing device may select a template having demographics metadata that matches the patient demographics of the patient profile and [23] which discloses demographic information may include height/weight).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified reference claim 1 such that the organ template is selected in accordance with a body size of the subject as taught by Reicher in order to further improve the accuracy of registering the template to the patient image (Reicher [46]).
Regarding instant claim 2,
Reference claim 3 recites the elements of instant claim 2 other than “in accordance with the size of the subject”. Examiner notes that Reicher further teaches this feature as noted above.
Regarding instant claim 3,
Reference claim 5 recites the elements of instant claim 3 other than “in accordance with the size of the subject”. Examiner notes that Reicher further teaches this feature as noted above.
Regarding instant claims 4-5,
Reference claims 1 and 3 recite the elements of instant claims 4-5 in that the posture of the subject is considered subject information.
Regarding instant claims 7-8,
Reicher, as applied to claim 4 above further teaches wherein the subject information includes at least one of height, weight, or age of the subject and gender of the subject ([23]).
Regarding instant claim 9,
Reference claim 7 recites the posture of the subject (i.e. subject information) designated by the user.
Regarding instant claim 10,
Reference claim 13 recites the processor is configured to select the one organ template based on the three-dimensional ultrasound image.
Regarding instant claim 13,
Reference claim 13 recites the processor is configured to select the organ template based on subject information (i.e. posture of the subject) and the three-dimensional ultrasound image.
Regarding instant claim 15,
Reicher, as applied to instant claim 1 above, teaches the elements of claim 15 (see 103 rejection above).
Regarding instant claims 16-19,
Reference claims 16-19 recite the elements of instant claims 16-19 respectively.
Examiner’s note
With respect to claim 14, Examiner notes that the closest prior art remains to be Caluser and Reicher. Reicher teaches wherein the processor is configured to calculate a degree of fitness with respect to the subject information and a degree of similarity with respect to the three-dimensional ultrasound image for each of the plurality of organ templates; select an organ template having a highest evaluation value as the one organ template, however, fails to explicitly teach calculating an evaluation value by obtaining a weighted average of the calculated degree of fitness and the calculated degree of similarity. Reicher is directed to selecting templates which match the patient profile and further determining a template which most closely matches the three-dimensional image. It would have required impermissible hindsight reasoning to have modified Caluser, or Caluser and Reicher to further include obtaining a weighted average of the calculated degree of fitness and the calculated degree of similarity and selecting an organ template having a highest evaluation value as currently required by the claims. The combination of elements of claim 14 therefore distinguishes over the prior art collectively, however, patentability is not determined at this time due to pending 101 rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Adler (WO 2019028103 A2) teaches a processor configured to select one organ template from amongst a plurality of organ templates according to a body size of a patient ([0047] and [0063])
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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