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 .
Notice to Applicant
Limitations appearing inside of {} are intended to indicate the limitations not taught by said prior art(s)/combinations.
Claims 1-20 are pending in the application.
Information Disclosure Statement
The information disclosure statement filed 08/05/2024 has been considered.
Drawings
The drawings are objected to because it appears there may be a typographical error in Figure 4 which exhibits item 16 when according to the disclosure (¶[0060]) it should be item 17.
PNG
media_image1.png
380
584
media_image1.png
Greyscale
PNG
media_image2.png
468
533
media_image2.png
Greyscale
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
Medical imaging facility in claim 13,
Analysis facility in claim 13, and
Reconstruction facility in claim 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10, and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Sabol” (Sabol, John M. et al. US 20040052328 A1).
Regarding claim 13, 13. A provision system for a medical image data set, comprising:
a medical imaging facility (interpretation: medical imaging facility can be or comprise a magnetic resonance facility and/or a computer tomography facility and/or a tomosynthesis facility and/or a PET facility and/or an ultrasound facility (CT system 10; Sabol, Fig 1) configured to acquire raw data in an acquisition process (tomographic data set … may be the raw image acquisition data ; Sabol, ¶[0047]);
at least one reconstruction facility (interpretation: “reconstructing a preliminary image data set from the raw data via a first reconstruction facility, wherein reconstruction parameters of a predetermined default parameter set are used” (¶[0014])) (See Sabol Fig 7 exhibits RECONSTRUCTION2-3 processes 125 (i.e., reconstruction facility)); and
an analysis facility (interpretation: “designed to provide computer aided diagnosis (CAD) and/or clinical decision support system (CDSS) and/or computer aided risk scoring (CARS)” (¶[0021])) (CAD processing; Sabol, ¶[0063]; and See Sabol, Fig 7 exhibits SEGMENTATION1-3 75, FEATURE EXTRACTION1-3 78 and CLASSIFICATION1-3 82 (i.e., analysis facility)), wherein the at least one reconstruction facility and the analysis facility are connected via a communication link (See Sabol, Fig 7 exhibits reconstruction 125, connected via communication link with segmentation 75, feature extraction 78, and classification 82 (i.e., analysis facility)),
wherein a first reconstruction facility of the at least one reconstruction facility is configured to reconstruct a preliminary image data set from the raw data (The tomographic data set on which the CAD algorithm is implemented may be the raw image acquisition data ; Sabol, ¶[0047]),
wherein reconstruction parameters of a predetermined default parameter set are used (Sabol teaches predetermined default parameters used in acquiring raw data used in reconstructing the tomographic data: acquisition parameters 84 may be provided by an operator or in an automated manner which affect the tomographic image date acquisition 72. Such acquisition parameters 84 may affect the set of tomographic data acquired and thereby influence the outcome of the CAD processes employed. Similarly, various situational variables 86, such as patient history, known physiological traits, equipment specific issues, or patient sensitivities and temperament may contribute to the selection of acquisition parameters 84.;Sabol, ¶[0046]),
the analysis facility is configured to analyze the preliminary image data set via an analysis algorithm to determine an item of analysis information that describes image content of the preliminary image data set (The segmentation portion 74 of the CAD algorithm, depicted in greater detail in FIG. 4, may identify a particular region of interest based upon calculated features in all or part of the tomographic data set 88.; Sabol, ¶[0048]),
the first reconstruction facility, a further reconstruction facility or the analysis facility is configured to determine a second parameter set of reconstruction parameters as a function of the analysis information (Post-processing 98 may include various combinatorial techniques for coordinating the results of the manual and automated segmentation processes. These combinatorial techniques may include manual adjustment of control points resulting from the automatic segmentation process, such as for threshold adjustment, contour adjustment, and other fine tuning steps; Sabol, ¶[0050]), and
the first reconstruction facility or the further reconstruction facility is configured to determine the medical image data set from at least one of the raw data or the preliminary image data set (acquired projection data 120 may be utilized in the reconstruction processes 125 which reconstruct the slice image data 122 or the image volume data 124 ( i.e., medical image data set); Sabol, ¶[0063]),
wherein the reconstruction parameters of the second parameter set are used to determine the medical image data set (A segmented data set 98 results from the segmentation process 92, 94 and the optional post-processing process (i.e., second parameter set); Sabol, ¶[0050]; The visualization process 80 of the CAD algorithm permits reconstruction of useful images for review by human or machine observers. Thus, various types of images may be presented to the attending physician or to any other person needing such information, based upon any or all of the processing and modules performed by the CAD algorithm; Sabol ¶[0056]).
Claim 1 is similarly analyzed as analogous claim 13.
Regarding claim 2, Sabol teaches the method of claim 1. Sabol further teaches wherein raw data from a screening examination is used (The tomographic data set on which the CAD algorithm is implemented may be the raw image acquisition data; Sabol, ¶[0047]).
Regarding claim 3, Sabol teaches the method of claim 2. Sabol further teaches wherein the screening examination is a tomosynthesis examination of a female breast (tomosynthesis mammography systems (XR); Sabol, [0027]).
Regarding claim 4, Sabol teaches the method of claim 1. Sabol further teaches wherein an overview image data set (interpretation: the overview image data set may be a synthetic 2D image and/or one that corresponds to a predetermined acquisition process (¶[0032])) is reconstructed as the preliminary image data set (the CAD processing may be performed on an acquisition projection data set prior to reconstruction, on two-dimensional reconstructed data (both in axial and scout modes), on three-dimensional reconstructed data (volume data or multiplanar reformats), or a suitable combination of such formats; Sabol ¶[[0045]).
Regarding claim 5, Sabol teaches the method of claim 1. Sabol further teaches wherein at least one of, the analysis algorithm comprises a trained analysis function the analysis algorithm is optimized, or the analysis algorithm is trained for use on the predetermined default parameter set (The training process 76 may be utilized to train the feature normalization process 112 to enhance the classification process based upon prior knowledge and experiences; Sabol, ¶[0059]).
Regarding claim 6, Sabol teaches the method of claim 1. Sabol further teaches wherein at least one of at least one annotation or a structured report is determined as the analysis information (The visualization 80 (i.e., reporting) may include two- or three-dimensional renderings, superposition of feature markers, color or intensity variations, and so forth. A superposed marker (i.e., annotation) may convey information, such as a feature classification, a probability associated with a classification, or three-dimensional location information of the feature, without obscuring the reconstructed anatomic data. In addition, while a marker may consist of a displayed pointer or text (i.e., annotation), it may also include a color-coded overlay, a color or intensity variation, or any other addition that is recognized and understood by the operator. Typically, CAD provides the ability to display such markers on any of the multiple data. This allows the reviewer to view only a single data or image upon which the results from an array of CAD operations, such as different levels or types of segmentation, feature extraction or classification processes, may be superimposed. In such cases, the markers may be differentiated, such as by color or shape, to allow the reviewer to determine which operation produced the marker; Sabol, ¶[0057]).
Regarding claim 7, Sabol teaches the method of claim 1. Sabol further teaches wherein the analysis information comprises at least one score, in particular a risk score, and/or lesion information relating to at least one potential lesion (The visualization 80 may include two- or three-dimensional renderings, superposition of feature markers, color or intensity variations, and so forth. A superposed marker may convey information, such as a feature classification, a probability associated with a classification, or three-dimensional location information of the feature, without obscuring the reconstructed anatomic data; Sabol, ¶[0057]).
Regarding claim 8, Sabol teaches the method of claim 1. Sabol further teaches wherein compared to the predetermined default parameter set, the reconstruction parameters of the second parameter set bring about at least one of a higher dimensionality, a higher resolution, a changed contrast, a contrast enhancement, a changed filtering, a changed binning, a changed, additional denoising, a changed layering property of layers of from the reconstructing, or lead to a reconstruction of additional image data, wherein in particular the medical image data set is determined by supplementing the preliminary image data set with additional data (The feature identification process 100 may also process the patient data 99 for information related to patient history, such as age, smoking, family history, pregnancy history, weight, BIRAD classification, genetic or proteomic profile, hormonal status, etc., for factors which may weight aspects of the feature identification process 100, such as by adjusting threshold values or weighting factors; Sabol, ¶[0052]).
Regarding claim 9, Sabol teaches the method of claim 1. Sabol further teaches wherein the medical image data set is stored in an image archiving facility (the operator workstation 40 may also be coupled to a picture archiving and communications system (PACS) 44. It should be noted that PACS 44 may be coupled to a remote system 46, radiology department information system (RIS), hospital information system (HIS) or to an internal or external network, so that others at different locations may gain access to the image and to the image data[ Sabol, ¶[0035]).
Regarding claim 10, Sabol teaches the method of claim 1. Sabol further teaches wherein the medical image data set is evaluated by the analysis facility using an evaluation algorithm to determine evaluation information that describes the image content (feature diagnosis may also be performed as part of the CAD algorithm by means of an optional feature classification process 82, as depicted in FIG. 3 and in greater detail in FIG. 6 ,Sabol, ¶[0058]).
Regarding claim 12, Sabol teaches the method of claim 1. Sabol further teaches wherein an evaluation result, which is determined by evaluating at least one user input from an evaluator, (See Sabol Fig 4 exhibits “MANUAL SEGMENTATION 92”; and “The segmentation may be manual, as depicted at block 92, allowing an operator to utilize a selection mechanism and the displayed image to select one or more portions of the image for differential processing”; Sabol, ¶[0049]).
PNG
media_image3.png
288
326
media_image3.png
Greyscale
is archived with the medical image data set (It should be noted that PACS 44 may be coupled to a remote system 46, radiology department information system (RIS), hospital information system (HIS) or to an internal or external network, so that others at different locations may gain access to the image and to the image data; Sabol, ¶[0035]; and Thus, various types of images may be presented to the attending physician or to any other person needing such information, based upon any or all of the processing and modules performed by the CAD algorithm; Sabol, ¶[0056]).
Regarding claim 14, Sabol teaches the method of claim 13. Sabol further teaches wherein the first reconstruction facility is part of the medical imaging facility (The computer 36 is typically coupled to the system controller 24. The data collected by the data acquisition system 34 may be transmitted to the computer 36 and moreover, to a memory 38. It should be understood that any type of memory to store a large amount of data may be utilized by such an exemplary system 10. Also the computer 36 is configured to receive commands and scanning parameters from an operator via an operator workstation 40 typically equipped with a keyboard and other input devices. An operator may control the system 10 via the input devices. Thus, the operator may observe the reconstructed image and other data relevant to the system from computer 36, initiate imaging, and so forth.; Sabol, ¶[0034]).
Regarding claim 15, Sabol teaches A non-transitory computer program product including instructions which, when executed in a provision system, causes the provision system to perform the method of claim 1 (Code stored on the tangible medium includes a routine for acquiring a tomographic data set from a tomographic mammography system; Sabol, ¶[0014]).
Regarding claim 16, Sabol teaches the method of claim 4. Sabol further teaches wherein the overview image data set is two-dimensional (the CAD processing may be performed on an acquisition projection data set prior to reconstruction, on two-dimensional reconstructed data (both in axial and scout modes), on three-dimensional reconstructed data (volume data or multiplanar reformats), or a suitable combination of such formats; Sabol ¶[[0045]).
Regarding claim 17, Sabol teaches the method of claim 6. Sabol further teaches wherein a structured report in a predefined format is determined as the analysis information (The visualization 80 may include two- or three-dimensional renderings, superposition of feature markers, color or intensity variations, and so forth. A superposed marker may convey information, such as a feature classification, a probability associated with a classification, or three-dimensional location information of the feature, without obscuring the reconstructed anatomic data. In addition, while a marker may consist of a displayed pointer or text, it may also include a color-coded overlay, a color or intensity variation, or any other addition that is recognized and understood by the operator. Typically, CAD provides the ability to display such markers on any of the multiple data. This allows the reviewer to view only a single data or image upon which the results from an array of CAD operations, such as different levels or types of segmentation, feature extraction or classification processes, may be superimposed. In such cases, the markers may be differentiated, such as by color or shape, to allow the reviewer to determine which operation produced the marker; Sabol, [0057]).
Claim 18 is similarly analyzed as analogous claim 8.
Claim 19 is similarly analyzed as analogous claim 12.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sabol in view of “Chen” (Chen; Yuanming et al. US 10734116 B2).
Regarding claim 11, Sabol teaches the method of claim 1. Sabol does not explicitly disclose wherein at least one of a further processing target or a task to be carried out is carried out using DICOM.
However, Chen, a similar field of endeavor of systems that store, share, render, simulate and/or facilitate imaging of medical procedures for purposes of optimized performance, simulation, training and/or accreditation, teaches wherein at least one of a further processing target or a task to be carried out is carried out using DICOM (wherein the at least one first 2D medical image computer data file comprises, is decoded from, or is generated from, a DICOM-format medical image file; Chen, [Col 11:1-4]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include DICOM image as taught by Chen to the invention of Sabol. The motivation to do so would be to utilize a common format of medical imaging. DICOM is a standard for handling, storing, printing, and transmitting information in medical imaging (Chen; [Col 9:1-15]).
Regarding claim 20, Sabol teaches the method of claim 1. Sabol does not explicitly disclose wherein at least the first reconstruction facility and the analysis facility are designed as DICOM clients.
However, Chen teaches wherein at least the first reconstruction facility and the analysis facility are designed as DICOM clients (according to the present invention, 2D/3D/4D medical image data can be viewed or edited without the need for special hardware and/or system. In other words, browsers would now have the capabilities to decode 2D/3D/4D medical image formats (e.g. DICOM images); Chen, [Col 9:48-52]; The workstation will be configured as a DICOM node inside the local area network; Chen, [Col 62:51-52]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reicher; Murray A. et al.US 20170200270 A1, would have been relied upon for teaching determining second parameter set of reconstruction parameters (“Referring again to FIG. 7, after a rendering location is determined, the rendering device will determine relevant rendering parameters from rules, data attributes, and/or environment variables (such as display resolution) at block 710. When ready, the system will render images at block 712” (¶[0183]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANDHANA PEDAPATI whose telephone number is 571-272-5325. The examiner can normally be reached M-F 8:30am-6pm (ET).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chan Park can be reached at 571-272-7409. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHANDHANA PEDAPATI/Examiner, Art Unit 2669
/JOHN B STREGE/Primary Examiner, Art Unit 2669
Prosecution Insights