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 .
Claim Status
Claims 1-10 are pending.
Priority
This application claims priority of Taiwan Patent Application No. 112146782, filed on December 1, 2023.
Information Disclosure Statement
The IDS filed 09/03/24, 04/30/25, and 01/28/26 are considered.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
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 limitations are:
“a storage module” in claim 6 (and claims 7-10 by dependency)
“a processing module” in claim 6 (and claims 7-10 by dependency)
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-2, 5-6, 7, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bi et al. (US 20050031181 A1 Hereinafter “Bi”) in view of in further view of Danner et al. (US 20090103789 A1 Hereinafter “Danner”) in further view of PEI et al. (TW 202131863 A Hereinafter “PEI”).
Regarding claim 1, Bi teaches a data processing method, comprising:
([0051]: “In the embodiment shown, the remote-site computer contains an integrated software package capable of (i) opening a DICOM-compliant file to retrieve radiographic image(s) and patient information therefrom”. The DICOM-compliant image file received acts as the second image file, and the predetermined condition is that it is DICOM-compliant);
scanning each of the second image files to obtain a file message of each of the second image files ([0051]: “In the embodiment shown, the remote-site computer contains an integrated software package capable of (i) opening a DICOM-compliant file to retrieve radiographic image(s) and patient information therefrom, (ii) carry out bone analysis operations on the retrieved image, (iii) enter new patient information, such as bone mineral mass, bone volume, bone mineral density, T-score, Z-score, fracture prediction, and a diagnostic statement, in the patient-data file”. The DICOM-compliant file contains both image information and patient information (which acts as the message). By opening the file it is scanned to obtain the image and patient information);
analyzing an image of each of the second image files to obtain a bone mineral density reference value corresponding to each of the images (Fig. 3, #74: “This contour information is used in a BMD analysis module 74 to determine the bone mineral density of every phalange”. The bone mineral density is determined from the images in the second image file);
calculating a T-score reference value and a Z-score reference value corresponding to each of the second image files according to the file messages and the bone mineral density reference values ([0051]: “In the embodiment shown, the remote-site computer contains an integrated software package capable of (i) opening a DICOM-compliant file to retrieve radiographic image(s) and patient information therefrom, (ii) carry out bone analysis operations on the retrieved image, (iii) enter new patient information, such as bone mineral mass, bone volume, bone mineral density, T-score, Z-score, fracture prediction, and a diagnostic statement, in the patient-data file”. The DICOM-compliant file contains both image information and patient information (which acts as the message). This patient data is used in the T and Z score calculation mentioned after the bone analysis of the image data, due to the T score needing the age and sex of the patient, and the Z score needing age, sex, and ethnicity of the patient, this information of the patient would be present in the patient information and used to calculate these values);
generating a plurality of bone mineral density determination results ([0051]: “In the embodiment shown, the remote-site computer contains an integrated software package capable of (i) opening a DICOM-compliant file to retrieve radiographic image(s) and patient information therefrom, (ii) carry out bone analysis operations on the retrieved image, (iii) enter new patient information, such as bone mineral mass, bone volume, bone mineral density, T-score, Z-score, fracture prediction, and a diagnostic statement, in the patient-data file”. The fracture prediction and diagnostic statement are the determination results); and
generating an output result according to the file messages, the T-score reference values, the Z-score reference values and the bone mineral density determination results ([0051]: “In the embodiment shown, the remote-site computer contains an integrated software package capable of (i) opening a DICOM-compliant file to retrieve radiographic image(s) and patient information therefrom, (ii) carry out bone analysis operations on the retrieved image, (iii) enter new patient information, such as bone mineral mass, bone volume, bone mineral density, T-score, Z-score, fracture prediction, and a diagnostic statement, in the patient-data file, and (iv) send the modified file to other sites, e.g., an archival site”. The modified file is the output result containing the file messages (patient information), T score, Z score, and bone mineral density determination results).
Bi does not expressly disclose obtaining first image files and screening them to generate the second image files that are used in the bone material density determination.
However, Danner teaches screening first image files to generate second image files to be processed according to a predetermined condition ([0009]: “A plurality of files stored on a computer are accessed, where the plurality of files include DICOM image files and non-DICOM image files. The DICOM image files are identified from among the plurality of files by scanning header data of the plurality of files when accessing the files. At least one of the identified DICOM image files is selected to be uploaded in response to user input”. The DICOM image format is the predetermined condition).
At the time the invention was made, it would have been obvious to one of ordinary skill in the art to modify Bi’s image file acquisition to include Danner’s screening of image files so select only DICOM image files because such a modification is the result of applying a known technique to a known device ready for improvement to yield predictable results. More specifically Danner’s screening of image files so select only DICOM image files permits a method for selecting the intended file format when there is more than just DICOM files present. This known benefit in Danner is applicable to Bi’s image file acquisition as they both share characteristics and capabilities, namely, they are directed to transmittance of medical image data through DICOM formats. Bi’s method requires that a DICOM compliant format is received for their process, Danner provides a method to assure only DICOM compliant files a received in a scenario when multiple file types are present. Therefore, it would have been recognized that modifying Bi’s image file acquisition to include Danner’s screening of image files so select only DICOM image files would have yielded predictable results because (i) the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate Danner’s screening of image files so select only DICOM image files in transmittance of medical image data through DICOM formats and (ii) the benefits of such a combination would have been recognized by those of ordinary skill in the art.
While it is presumed that the determination of bone material density results would be in respect to the T and Z in relation to a predetermined value, Bi does not expressly disclose determining the bone mineral density results according to the T-score reference values and a first predetermined value or the Z-score reference values and a second predetermined value.
However, PEI teaches determining the bone mineral density results according to the T-score reference values and a first predetermined value or the Z-score reference values and a second predetermined value (Page 6, fourth to last paragraph: “Next, as shown in step S15, the processing unit 5 determines whether the bone density estimation data meets a predetermined warning condition, if yes, then executes step S16, if not, the process ends. In this embodiment, the predetermined warning condition includes a T-score corresponding to the bone density estimation data being less than a T-score threshold, and a Z-score corresponding to the bone density estimation data. ) Is less than a Z-score threshold, and as long as the T-score is less than the T-score threshold or the Z-score is less than the Z-score threshold, step S16 is then executed”).
At the time the invention was made, it would have been obvious to one of ordinary skill in the art to modify Bi’s bone mineral density results determination to include PEI’s use of a first predetermined value for the T score and second predetermined value for the Z score for bone mineral density result determination because such a modification is the result of applying a known technique to a known device ready for improvement to yield predictable results. More specifically, PEI’s use of a first predetermined value for the T score and second predetermined value for the Z score for bone mineral density result determination permits a method for accurately determining if the bone mineral density results are at abnormal levels by comparing the results to a known threshold for abnormal levels. This known benefit in PEI is applicable to Bi’s bone mineral density results determination as they both share characteristics and capabilities, namely, they are directed to calculating the T and Z score of patients using their bone material density information. It is presumed that Bi uses T and Z scores of patients to determine if there is abnormal bone mineral density values, PEI simply provides a way to determine abnormal values using the predetermined values (thresholds). Therefore, it would have been recognized that modifying Bi’s bone mineral density results determination to include PEI’s use of a first predetermined value for the T score and second predetermined value for the Z score for bone mineral density result determination would have yielded predictable results because (i) the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate PEI’s use of a first predetermined value for the T score and second predetermined value for the Z score for bone mineral density result determination in calculating the T and Z score of patients using their bone material density information and (ii) the benefits of such a combination would have been recognized by those of ordinary skill in the art.
Regarding claim 2, the combination of Bi, Danner, and PEI teaches the data processing method as claimed in claim 1, in addition, Danner further teaches wherein the predetermined condition comprises a predetermined file format or a predetermined image resolution ([0009]: “A plurality of files stored on a computer are accessed, where the plurality of files include DICOM image files and non-DICOM image files. The DICOM image files are identified from among the plurality of files by scanning header data of the plurality of files when accessing the files. At least one of the identified DICOM image files is selected to be uploaded in response to user input”. The DICOM image format is the predetermined condition).
The rationale for this combination is similar to the rationale for the combination of Bi and Danner in the claim 1 rejection due to similar methods of combination (using Danner to select files that Bi can use) and benefits (Bi can use Danner’s method to obtain DICOM compliant files when there is multiple file types present).
Regarding claim 5, the combination of Bi, Danner, and PEI teaches the data processing method as claimed in claim 1, in addition, Bi further teaches further comprising:
storing the output result and the second image files in a same folder ([0051]: “The operations described with respect to FIG. 3 illustrate a typical distribution of activities that can be performed with the system of the invention, where a patient file may be established at one site, a digital radiographic image taken at the same or a second site, image analysis performed at another site, and reporting and patient consultation carried out at still another site. In the embodiment shown, the remote-site computer contains an integrated software package capable of (i) opening a DICOM-compliant file to retrieve radiographic image(s) and patient information therefrom, (ii) carry out bone analysis operations on the retrieved image, (iii) enter new patient information, such as bone mineral mass, bone volume, bone mineral density, T-score, Z-score, fracture prediction, and a diagnostic statement, in the patient-data file, and (iv) send the modified file to other sites, e.g., an archival site”. The output result (new patient information) is stored in the same file as the second image files); and
storing the file message, the T-score reference value, the Z-score reference value and the bone mineral density determination result corresponding to a file name of each of the second image files as a personal report file according to the file name of each of the second image files ([0051]: “In the embodiment shown, the remote-site computer contains an integrated software package capable of (i) opening a DICOM-compliant file to retrieve radiographic image(s) and patient information therefrom, (ii) carry out bone analysis operations on the retrieved image, (iii) enter new patient information, such as bone mineral mass, bone volume, bone mineral density, T-score, Z-score, fracture prediction, and a diagnostic statement, in the patient-data file, and (iv) send the modified file to other sites, e.g., an archival site”. The modified file is the output result containing the file messages (patient information), T score, Z score, and bone mineral density determination results. These would correspond to a file name (by virtue of being in the file) of each of the second image files as a personal report file (file containing personal information of the patient), and this would be according to the file name of each of the second image files).
Regarding claim 6, the content of claim 6 is similar to the content of claim 1, with the additional teachings of a data processing device, a storage module, and a processing module. Bi also discloses this information:
Data processing device (Fig. 8 shows the processing device and components, #160 specifically),
A storage module (Fig. 8 shows the image data and processed image, the image would have to be stored to be used and for the image to be stored there must be a storage module),
Processing module (Fig. 8 shows the image processing module #170).
Therefore, claim 6 is rejected for the same reasons of obviousness as claim 1, along with the additional teachings above.
Regarding claim 7, the content of claim 7 is similar to the content of claim 2, therefore it is rejected for the same reasons of obviousness as claim 2.
Regarding claim 10, the content of claim 10 is similar to the content of claim 5, therefore it is rejected for the same reasons of obviousness as claim 5.
Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Bi et al. (US 20050031181 A1 Hereinafter “Bi”) in view of in further view of Danner et al. (US 20090103789 A1 Hereinafter “Danner”) in further view of PEI et al. (TW 202131863 A Hereinafter “PEI”) in view of Sarrafzadeh et al. (US 20120221310 A1 Hereinafter “Sarrafzadeh”) as evidenced by NOTOHARA et al. (US 20200214657 A1 Hereinafter “NOTOHARA”).
Regarding claim 3, the combination of Bi, Danner, and PEI teaches the data processing method as claimed in claim 1, in addition, Bi further teaches wherein the file message comprises ([0057]: “FIG. 5 illustrates a DICOM-compliant file 100 for a patient, in accordance with the invention. Included in the file are a header subfile 102, and subfiles 104 and 106 for patient demographics and diagnostic results, respectively. The header subfile includes patient and file-identifying information such as patient name, age, address, referring physician, and the like”).
While it is presumed date of birth, gender, and ethnicity would be included in Bi’s patient demographics, the combination of Bi, Danner, and PEI does not expressly disclose the file message containing date of birth, gender, and ethnicity.
However, Sarrafzadeh teaches that patient demographics can include date of birth, gender, and ethnicity ([0013]: “Database 106 can decode and store a segment of the raw data representing the signal from one or more sensors 104, 105 and meta data which can include the patient's demographic such as name, gender, ethnicity, date of birth, and so on”).
At the time the invention was made, it would have been obvious to one of ordinary skill in the art to modify the combination of Bi, Danner, and PEI’s demographic data to include Sarrafzadeh’s demographic data containing date of birth, gender, and ethnicity because such a modification is the result of applying a known technique to a known device ready for improvement to yield predictable results. More specifically, Sarrafzadeh’s demographic data containing date of birth, gender, and ethnicity permits patient data that contains all the necessary patient statistics for performing further operations. This known benefit in Sarrafzadeh’s is applicable to the combination of Bi, Danner, and PEI’s demographic data as they both share characteristics and capabilities, namely, they are directed to using patient demographic data to predict medical conditions. It is presumed that the combination of Bi, Danner, and PEI uses date of birth (age), gender, and ethnicity to calculate T and Z scores of patients (those aspects must be known to calculate those parameters) they do not explicitly disclose obtaining them, Sarrafzadeh’s provides demographic data that explicitly contains the parameters they need. Therefore, it would have been recognized that the combination of Bi, Danner, and PEI’s demographic data to include Sarrafzadeh’s demographic data containing date of birth, gender, and ethnicity would have yielded predictable results because (i) the level of ordinary skill in the art demonstrated by the references applied shows the ability to incorporate Sarrafzadeh’s demographic data containing date of birth, gender, and ethnicity in using patient demographic data to predict medical conditions and (ii) the benefits of such a combination would have been recognized by those of ordinary skill in the art.
With Bi using DICOM image files, they have a specific format, this specific format would contain the date of shooting, as evidenced NOTHARA ([0026]: “The X-ray image confirming to the Dicom standard consists of: an information area in which various types of information are recorded, such as an imaging date and time, a patient name, and imaging conditions”).
Regarding claim 8, the content of claim 8 is similar to the content of claim 3, therefore it is rejected for the same reasons of obviousness as claim 3.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Bi et al. (US 20050031181 A1 Hereinafter “Bi”) in view of in further view of Danner et al. (US 20090103789 A1 Hereinafter “Danner”) in further view of PEI et al. (TW 202131863 A Hereinafter “PEI”) in view of Ito et al. (US 6132373 A Hereinafter “Ito”).
Regarding claim 4, the combination of Bi, Danner, and PEI teaches the data processing method as claimed in claim 1,
The combination of Bi, Danner, and PEI does not expressly disclose outputting the results in the form of a table.
However, Ito teaches outputting diagnostic results in table form (Col. 14, lines 50-55: “The results of the diagnosis and evaluation are output as an evaluation table”).
At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the combination of Bi, Danner, and PEI’s output results to include Ito’s result table because such a modification is taught, suggested, or motivated by the art. More specifically, the motivation to modify the combination of Bi, Danner, and PEI to include Ito is expressly provided Ito, stating that “The results of the diagnosis and evaluation are output as an evaluation table. This enables proper diagnosis based on clinical data and gives a patient the motivation to take care of himself/herself” (Col. 14, lines 50-55). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the combination of Bi, Danner, and PEI’s output results to include Ito’s result table with the motivation of enabling proper diagnosis. The person of ordinary skill in the art would have recognized the benefit of improved functionality for use by clinician or patient.
Regarding claim 9, the content of claim 9 is similar to the content of claim 4, therefore it is rejected for the same reasons of obviousness as claim 4.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
NAGHAVI (US 20240120095 A1) teaches determination of T and Z score for Bone mineral density calculations.
KALVESTEN (US 20130184556 A1) teaches determination of T and Z score for Bone mineral density calculations.
BREGMAN-AMITAI (US 20160015347 A1) teaches determination of bone mineral density
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/STEFANO ANTHONY DARDANO/ Examiner, Art Unit 2663
/GREGORY A MORSE/Supervisory Patent Examiner, Art Unit 2698