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 Arguments
Applicant’s arguments, see pages 8-13, filed 14 August 2026, with respect to 112 and 103 rejections for claims 1 and its dependent claims have been fully considered and are persuasive in view of amendment. The 103 rejection of 15 May 2026 has been withdrawn.
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, 3-5, 8-10, 12-13, and 19-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a method for automatic assessment of breast morphology, thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 1 recites the limitations:
processing the 3D sensor data to determine one or more breast morphology parameters in respect of one or more breasts in the breast area, wherein the processing comprises:
generating a 2D image projection of a curvature response of the 3D sensor data;
detecting, in the 2D image, one or more key points;
estimating at least one 2D breast region boundary based on the one or more key points;
extrapolating the at least one 2D breast boundary region into 3D space to project the at least one breast boundary region onto a 3D image of the breast area;
determining the one or more breast morphology parameters based on the at least one breast region boundary defined in one or more of the 2D and 3D images of the breast area; and
generating an output comprising the one or more breast morphology parameters, wherein after determining one or more breast morphology parameters,
the method further comprises determining a dissimilarity between a current breast morphology and a desired breast morphology, comprising:
generating an iso-contour for at least one breast region;
generating N-level curves within the breast region boundary of the at least one breast region;
for each i-th level curve of the N-level curves:
applying a binary mask to generate a foreground region corresponding to the location of the breast region;
estimating a bounding box around the foreground region, and a box centroid, to generate a target foreground region; and
overlaying a reference foreground region over the target foreground region to generate an overlayed region comprising an overlap area and one or more non-overlap areas, wherein the reference foreground region is associated with the desired breast morphology and the target foreground region is associated with the current breast morphology.
These limitations, as drafted, are a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of mathematical manipulations and concepts performed in the human mind with a physical aid as well as certain methods of organizing human activities (such as following rules/instructions).
These actions fall under the Mental Processes, Mathematical Concepts, and Certain Methods of organizing human activities categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations,” and “managing personal behavior or relationships or interactions between people.” A human, such as surgeon and/or physician, could mentally perform tasks of observing the image data, detecting key points (by opinion), estimate boundaries based on determined key points, and determining morphological parameters based on observing the boundary and determining a dissimilarity between two morphologies, by comparison and estimating bounding box and a box centroid can be performed by defining region of interest and calculating its geometrical center by observation and opinion, and physically overlaying two images/data (by simply overlapping two images to have region of overlapping and non-overlapping).
In addition, a person can generate 2D projection of a curvature response of the 3D data, using mathematical manipulation of data by applying known mathematical formulas and using mental framework of judgement and opinion with an aid of pen and pencil, such as extrapolating data (using extrapolation equation), and generating an iso-contour of the region (by connecting into a line or curve of the points of equal value), N-level curves (by applying function of two variables equal to a constant value), applying a binary mask (by applying multiplication of data with a mathematical matrix of mask). A surgeon can proceed to generate an output with one or more breast morphology parameters, by presenting a paper with an outcome to others or presenting the outcome in a presentation, which can be considered as “following rules of instructions” or teaching belonging to managing personal behavior or relationship or interactions between people under “Certain methods of organizing human activity.”
These steps can all be performed in the mind with aid of a pen and paper with applying mathematical calculations and known formulas and following steps of calculations to arrive at the conclusion and presenting the conclusion to others.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a combination of mental process-type, mathematical concepts and certain methods of organizing human activity type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
receiving three-dimensional (3D) sensor data of a breast area;
This claim elements of receiving three-dimensional sensor data of a breast area is mere data collection step which amounts to a pre-solution insignificant. The claim of receiving data is simply gathering image data which are necessary precursors for all uses of the recited abstract idea since no determination of key points, performing steps of mathematical manipulation to convert data, and determining a dissimilarity can be performed without first gathering necessary image data.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical calculations) using rules (e.g., computer instructions) executed by a computer (e.g., processor as disclosed in specification).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 1 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite the following additional elements:
receiving three-dimensional (3D) sensor data of a breast area;
The above-identified additional elements of “receiving 3D sensor data” is performed using all generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a “standard desktop computer” ([0088]), which elements are disclosed with high generality leading to a conclusion that these elements are well-known in the field.
With respect to “ camera image acquired by a camera,” specification describes a camera in high generality, and the examiner submits that Yadiv (US 2019/0011709) discloses digital video cameras recording a real time 3D images using commercially available cameras including various brands such as Panasonic HX-A1 and Swiss Ranger 5R 4000/4500 and carmin and capri series cameras ([0026]).
Accordingly, in light of applicant’s specification, the claimed term computer/processor are reasonably construed as a generic computing device (“Standard desktop computer”). Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computing device. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Therefore, the examiner concludes that receiving data by computer/processor are common use in medical image guidance, and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claim 1 is ineligible.
Claims 3-5, 8-10, 12-13, and 19-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a method for automatic assessment of breast morphology, thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 1 recites the limitations:
Of claim 3, wherein the key points correspond to a position location of one or more of a right nipple areolar complex (NAC), a left NAC and a sternal notch.
Of claim 4, wherein detecting the one or more key points in the 2D image comprises:
bisecting the 2D image to generate a right sub-image and a left sub-image; within each sub-image, determining the point of maximum curvature as corresponding to the right NAC and left NAC key points, respectively; cropping the 2D image to generate a cropped image, wherein the bottom left and right corners of the cropped image are aligned with the right and left NAC key points, respectively; and within the cropped image, determining the point of maximum curvature as corresponding to the sternal notch (SN) key point.
Of claim 5, wherein estimating at least one 2D breast boundary region based on the one or more key points comprises: identifying a respective higher curvature region around each of the right and left NAC key points corresponding to higher curvature response; and fitting an ellipse around the respective NAC key point and the high curvature region, wherein the ellipse fitted around the high curvature region including the right NAC key point defines the right breast region boundary, and the ellipse fitted around the high curvature region including the left NAC key point defines the left breast region boundary.
Of claim 8, wherein the non-overlap areas comprise one or more of false negative areas and false positive areas, wherein the false negative areas are areas which exist in the reference foreground region and not in the target foreground region, and false positive areas are areas which exist in the target foreground region and not in the reference foreground region.
Of claim 9, further comprising stacking the overlayed regions for each successive i-th level curve to generate a 3D visualization of the overlayed regions.
Of claim 10, wherein determining the pseudo- volume of a breast region comprises: adding the areas within the iso-contours from all N-level curves.
Of claim 12, further comprising determining determine a degree of asymmetry between the breasts, wherein for each i-th level curve, the method comprises:
selecting the foreground region for one of the breast regions as being the target foreground region and reference foreground region; flipping the reference foreground region, across a median line defined with respect to the sternal notch key point, to overlay the target foreground region.
Of claim 13, further comprising determining a "Volumetric and Iso-contour based Morphological Asymmetry" (VIMA) score according to the equation: VIMA = 1 - [ 1 * mloU + (1 - 1) * Vᵣ ] wherein A is an empirically determined variable, mloU is a mean intersection over union (IoU) determined across all N-level curves and Vᵣ is a ratio of breast mound volumes.
Of claim 19, wherein the output comprises a graphical output.
Of claim 20, wherein the graphical output comprises a 3D visualization of the a stacking of the overlayed regions for each successive i-th level curve.
Of claim 21, wherein the 3D visualization comprises, for each overlayed region in each i-th level curve, different visual indicia for an the overlap area and the-one or more non-overlap areas.
Of claim 22, wherein the 3D visualization comprises, for each overlayed region in each i-th level curve, different visual indicia for each of the false negative areas and the false positive areas.
Of claim 23, wherein the different visual indicia correspond to a-different color or shading schemes.
These limitations, as drafted, are a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of mathematical manipulations and concepts performed in the human mind with a physical aid as well as certain methods of organizing human activities (such as following rules/instructions).
These actions fall under the Mental Processes, Mathematical Concepts, and Certain Methods of organizing human activities categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations,” and “managing personal behavior or relationships or interactions between people.” A human, such as surgeon and/or physician, could mentally perform tasks of observing the image data, detecting right nipple areolar complex and NAC and a sternal notch in the image (by observation), bisecting image into right and left (by dividing into right and left), and within each image, find maximum curvature corresponding to NAC and cropping the image wherein the bottom left and right corners is aligned with the key points and determine maximum curvature point to be sternal notch (by observation, evaluation and judgement), identifying region around key points with higher value of curvature response (by observation and selection), fitting an ellipse around the key points and high curvature region identified, to include region containing key points (by identifying regions and fitting an ellipse to set a boundary, by selection and opinion), and determining morphological parameters based on observing the boundary and determining a dissimilarity between two morphologies, by comparison and estimating bounding box and a box centroid can be performed by defining region of interest and calculating its geometrical center by observation and opinion, and physically overlaying two images/data (by simply overlapping two images to have region of overlapping and non-overlapping).
In addition, a person can stack overlayed regions for each curve to generate a 3D visualization using mathematical manipulation of data by applying known mathematical formulas and using mental framework of judgement and opinion with an aid of pen and pencil, such as adding N-level curves (by applying function of two variables equal to a constant value), adding areas within iso-contours from all curves (by addition), determining a degree of asymmetry, by selecting region and flipping along a median line (Folding selected region along the midline to determine symmetry), using formula in claim 13, one can determine a score of asymmetry by plugging in values to variables. In addition, one can select images and its details, such as different color, shading schemes to represent different characteristics of regions of the image, and produce an image with selected graphics, thus can be performed by opinion and judgement, and draw the image with colors, or color-print the results. A surgeon can proceed to generate an output with one or more breast morphology parameters, by presenting a paper with an outcome in graphical output (such as printed paper with image) to others or presenting the outcome in a presentation, which can be considered as “following rules of instructions” or teaching belonging to managing personal behavior or relationship or interactions between people under “Certain methods of organizing human activity.”
These steps can all be performed in the mind with aid of a pen and paper with applying mathematical calculations and known formulas and following steps of calculations to arrive at the conclusion and presenting the conclusion to others.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a combination of mental process-type, mathematical concepts and certain methods of organizing human activity type abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No – No additional limitations were recited.
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – No additional limitations were recited.
In light of the above, claims 3-5, 8-10, 12-13, and 19-24 are ineligible.
Claims 24-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a method for automatic assessment of breast morphology, thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes – set forth in claim 1 above.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
Of claim 24, wherein the output is generated on a display interface associated with a user device or a remote computer terminal.
Of claim 25, further comprising: receiving, via an input interface of the user device, a selection of one of the selected level curves in the 3D visualization; and updating, on the display interface, the visualization to show visual indicia for the overlap and non-overlap areas for that the selected level curve.
Of claim 26, A system for automatic assessment of breast morphology, comprising:
at least one 3D image sensor for generating 3D sensor data; and
at least one processor configured to perform the method of claim 1.
Of claim 27, A non-transitory computer readable medium storing computer executable instructions, which upon execution by at least one processor, cause the at least one processor to perform the method of claim 1.
This claim elements of input to receive live 3D image acquired from 3D imaging sensor is mere data collection step which amounts to a pre-solution insignificant activity and displaying with a user interface for selecting and updating the visualization is mere outputting the result, amounts to a post-solution insignificant activity. The use of processor, an input interface, and computer storage medium is recited with high generality of performing the abstract ideas. The claims do not specify any configuration or improvement in the image sensor and processor itself, just simply gathering image data which are necessary precursors for all uses of the recited abstract idea since no analysis and determining morphological parameters can be performed without first gathering necessary image data.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical calculations) using rules (e.g., computer instructions) executed by a computer (e.g., processor as disclosed in specification).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 1 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite the following additional elements:
Of claim 24, wherein the output is generated on a display interface associated with a user device or a remote computer terminal.
Of claim 25, further comprising: receiving, via an input interface of the user device, a selection of one of the selected level curves in the 3D visualization; and updating, on the display interface, the visualization to show visual indicia for the overlap and non-overlap areas for that the selected level curve.
Of claim 26, A system for automatic assessment of breast morphology, comprising:
at least one 3D image sensor for generating 3D sensor data; and
at least one processor configured to perform the method of claim 1.
Of claim 27, A non-transitory computer readable medium storing computer executable instructions, which upon execution by at least one processor, cause the at least one processor to perform the method of claim 1.
The above-identified additional elements of “3D image sensor” is performed using a Time of Flight camera and LiDAR sensor ([0021]), “user interface” and/or “user device” is performed by a cell phone ([0088]), and “processor” and “computer-readable medium storing computer executable instructions” is performed using all generically claimed computer components (such as smart phone device [0063]) which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a “standard desktop computer” ([0088]), “smart-phone” and “cell-phone,” which elements are commercially available products (such as iphone or galaxy) and disclosed with high generality leading to a conclusion that these elements are well-understood, routine and conventional in the field.
With respect to “ 3D imaging sensor,” specification describes ToF camera or radar sensor, and the examiner submits that Tangy (US 2014/0336515) discloses 3D imaging of breast acquisition is performed using a mobile phone equipped with radar ([0007]), thus using a mobile phone for 3D imaging of breast region is performed using commercially available product, a mobile phone (such as iphone, smartphone).
Accordingly, in light of applicant’s specification, the claimed term computer/processor are reasonably construed as a generic computing device (“Standard desktop computer”). Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the computing device. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Therefore, the examiner concludes that 3D imaging sensor and computer/processor and user device are common use in breast diagnostic images, and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claims 24-27 are ineligible.
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, 3-5, 8-10, 12-13, and 19-27 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 amended limitation "the location of the breast region" in page 2. There is insufficient antecedent basis for this limitation in the claim, because “a location of the breast region” was not previously recited in claim 1.
Claim 4 recites the amended limitation "the point of maximum curvature" “the bottom left and right corners” in page 3. There is insufficient antecedent basis for this limitation in the claim, because “a location of the breast region” was not previously recited in claim 1.
Claim 10 recites the amended limitation “the pseudo-volume of a breast region” and “the areas” in page 4. There is insufficient antecedent basis for this limitation in the claim, because “a location of the breast region” was not previously recited in claims 1 and 10.
Claim 12 recites the amended limitation “the sternal notch key point” in page 4. There is insufficient antecedent basis for this limitation in the claim, because “a sternal notch key point” was not previously recited in claim 1.
Claims 3-5, 8-10, 12-13, and 19-27 are rejected as they inherit rejection of claim 1 as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
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/PATRICIA J PARK/Primary Examiner, Art Unit 3798
