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 Objections
Claims 1-10 are objected to because of the following informalities: claims 1-10 recite numerical number in parenthesis to refers to specific claim elements which are objected and should be deleted. Appropriate correction is required.
Claim 1 objected to because of the following informalities: claim recites “Bone Mineral Density” in line 12 should be amended to recite –bone mineral density--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: claim limitation “Chest” should be amended to recite –chest--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: the claim limitation “Region of Interests” in the claim should be amended to recite –region of interests--. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the claim limitation “Region of Interests” in the claim should be amended to recite –region of interests--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: claim recites “Bone Mineral Density” in lines 1-2 should be amended to recite –bone mineral density--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: claim recites “Hip” and “Spine” should be amended to recite –hip—and –spine--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: claim recites “Osteoporotic Fracture Riske Score” in line 7 should be amended to recite – osteoporotic fracture risk score --. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: claim recites “Osteoporotic Hip Fracture Risk Score” in line 8 should be amended to recite – osteoporotic hip fracture risk score --. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: claim recites “Bone Mass Indices of the Clavicle Region of Interest” in line 9 should be amended to recite –bone mass indices of the clavicle region of interest--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: claim recites “Hip” and “Spine” should be amended to recite –hip—and –spine--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: claim recites “Diagnostic” in line 7, “Osteopenia” in line 7 and “Osteoporosis” in line 8 should be amended to recite –diagnostic--, --osteopenia—and –osteoporosis--. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: claim recites “IO-year” in line 5 should be amended to recite –10-year--. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: claim recites “Major Bones Osteoporotic Fracture Risk Score” in line 4, “Osteoporotic Hip Fracture Risk Score” in line 5, and “Osteoporotic” in line 6 should be amended to recite – major bones osteoporotic fracture risk score --, ----osteoporotic hip fracture risk score —and –osteoporotic--. Appropriate correction is required.
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:
“a receiving module” in claim 1, and all dependent claims thereof;
“a determining module” in claim 1, and all dependent claims thereof;
“a Bone Mineral Density (BMD) estimation module” in claim 1, and all dependent claims thereof;
“a risk assessment module” in claim 1, and all dependent claims thereof;
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 § 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 1-10 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.
Regarding claim 1, the claim limitation “other modules” in line 13 is indefinite because it is unclear what is meant by the other modules since claim 1 limits several different modules. The specification does not explicitly define what the other modules are.
Regarding claim 2, the claim limitation “the modules” is indefinite because it is unclear if the modules is referring to the modules or the other modules in claim 1. The examiner notes that the numerical number within the parenthesis is not part of the claim so therefore the number “106” withing the parenthesis referring the “the modules” in claim 2 does not differentiate from “the modules” and “other modules” from claim 1.
Furthermore, for claim 2, the claim limitation “the estimation of bone fracture risk” in line 2 lacks antecedent basis.
Regarding claim 5, the claim recites “(clavicle bone)” in line 8 is indefinite because it is unclear if the claim limitations in the parenthesis is part of the claim. For examining purposed, it is assumed any claim limitation in the parenthesis is not part of the claim.
Regarding claim 6, the claim limitation “the bilateral clavicle bone” in line 2 is indefinite because it is unclear what bilateral clavicle bone the claim is referring to.
Furthermore, for claim 6, the phrase “ideal location” in line 3 is a relative term which renders the claim indefinite. The term “ideal location” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the phrase “ideal location” renders the claim limitation “an ideal location for an automated digital radiographic bilateral clavicle radiogrammetry measurements” indefinite.
Regarding claim 7, the claim recites several claim limitations in parenthesis which are indefinite because it is unclear if these claim limitations in the parenthesis is part of the claim. For examining purposed, it is assumed any claim limitations in the parenthesis are not part of the claim.
Furthermore, for claim 7, the claim limitations of estimate a hip (neck) BMD and hip (total) BMD are indefinite because it is unclear what is the different between the two hip BMD since the claim limitation in the parenthesis is not part of the claim limitations and does not differentiate the two hip BMD.
Furthermore, for claim 7, the claim limitations “the calculated Bone Mass Indices” and “the Clavicle Region of Interests” in line 9 lacks antecedent basis.
Regarding claim 8, the claim limitation “calculated T-Score” in line 3 is indefinite because it is unclear what calculated T-score the claim is referring to since claim 1 does not limit calculating a T-score.
Furthermore, for claim 8, the claim limitation “estimated bone mineral density” in lines 3-4 is indefinite because it is unclear what estimated bone mineral density the claim is referring to since claim 1 does not limit estimating any bone mineral density.
Furthermore, for claim 8, the claim limitation “estimated T-score” in line 5 is indefinite because it is unclear what estimated T-Score the claim is referring to since claim 1 does not limit estimating any bone mineral density, and it is unclear if the estimate T-score is referring to the calculated T-score.
Furthermore, for claim 8, the claim limitations of calculated T-Score of dual hips (neck) and dual hips (total) in line 3 are indefinite because it is unclear what is the different between the two dual hips T-Score since the claim limitation in the parenthesis is not part of the claim limitations and does not differentiate the two dual hip T-Score.
Furthermore, for claim 8, the claim limitations of estimated bone density of the hips and dual hips in line4 are indefinite because it is unclear what is the different between the two hips BMD since the claim limitation in the parenthesis is not part of the claim limitations and does not differentiate the two hips BMD.
Furthermore, for claim 8, the claim limitations of estimated T-Score of dual hips (neck) and dual hips (total) in line 5 are indefinite because it is unclear what is the different between the two dual hips T-Score since the claim limitation in the parenthesis is not part of the claim limitations and does not differentiate the two dual hip T-Score.
Furthermore, for claim 8, the claim limitation “the patient” in line 7 lacks antecedent basis.
Regarding claim 9, the claim limitation “estimated fracture risk scores” in lines 2-3 is indefinite because it is unclear what estimated fracture risk scores the claim is referring to since claim 1 does not limit estimating any bone mineral density.
Furthermore, for claim 9, the claim limitation “the high future risk” in line 7 lacks antecedent basis.
Furthermore, for claim 9, the term “high” in line 6 is a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the term “high” renders clam limitation “high future risk” indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1-5 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (US 2023/0029674; hereinafter Lin).
Regarding claim 1, Lin discloses a method for generating skeletal characteristic values related to bone quality. Lin shows a system for bone fracture risk assessment (see abstract; fig. 1; par. [0044]), wherein the system comprises: a processor (see par. [0044]); an Input/Output (1/0) interface coupled with the processor (see fig. 1; par. [0044], [0047]); and - a memory for storing instructions executable by the processor (see fig. 1 and 2A-B; par. [0044], [0047]), wherein the memory (104) comprises modules (see par. [0044]) and data (see fig. 1 and 2A-B), wherein the data comprises one or more images (see fig. 1), region of interests (see abstract; fig. 1; par. [0047]) and a bone mineral density (see par. [0007]), and wherein the modules comprise a receiving module (see par. [0044]; fig. 1 and 2A-B), a determining module (see par. [0044]; fig. 1 and 2A-B), a Bone Mineral Density (BMD) estimation module (see par. [0044]; fig. 1 and 2A-B), a risk assessment module (see par. [0044]; fig. 1 and 2A-B) and other modules (see par. [0044]; fig. 1 and 2A-B).
Regarding claim 2, Lin shows wherein the modules are configured to perform the estimation of bone fracture risk employing the data (see par. [0045].
Regarding claim 3, Lin shows Lin shows wherein the receiving module is configured to receive the one or more images of a standard digital or computed Chest X-ray radiograph (see fig. 1 and par. [0007]).
Regarding claim 4, Lin shows wherein the one or more images comprises the standard digital or computed chest X-ray radiograph for a fully automated computerized digital or computed X-ray radiographic image processing and one or more images is in a form of a gray-scale image (see fig. 2A and 2B; par. [0046], [0047]).
Regarding claim 5, Lin shows wherein the determining module (111) is configured to: determine Region of Interests on the one or more images (see fig. 1 and 1B, par. [0008]; and utilize a deep neural network architecture and the deep neural network architecture is trained with a data set of images and their corresponding masks created at the Region of Interests (see par. [0046], [0047], [0048], [0051]; fig. 2A-B), wherein the determining module performs a mapping process to segment masked region automatically from the one or more images using the trained deep neural network architecture (see par. [0046], [0047], [0048], [0051]; fig. 2A-B).
Regarding claim 10, Lin shows wherein the other modules are configured to perform a standard pre-processing on the one or more images (see par. [0054]), and wherein the standard pre-processing performed by employing an image equalization technique to obtain the one or more images with improved contrast (see par. [0054]).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2023/0029674; hereinafter Lin), in view of Chen et al. (US 2009/0285467l hereinafter Chen).
Regarding claim 6, Lin discloses the invention substantially as described in the 102 rejection above, but fails to explicitly state wherein the Region of Interests (ROI) is an intersection point of the bilateral clavicle bone and an end enclosure part of a rib bone.
Chen discloses a method for assessing bone status. Chen teaches Region of Interests (ROI) is an intersection point of the bilateral clavicle bone and an end enclosure part of a rib bone (see fig. 1 and 3-4). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of Region of Interests (ROI) is an intersection point of the bilateral clavicle bone and an end enclosure part of a rib bone in the invention of Lin, as taught by Chen, to be able to assess bone status of bones around the rib and collarbone.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2023/0029674; hereinafter Lin), in view of Dixon et al. (US 2005/0015002; hereinafter Dixon).
Regarding claim 7, Lin disclose the invention substantially as described in the 102 rejection above, furthermore, Lin shows wherein the Bone Mineral Density (BMD) estimation module (112) is configured to: perform automated digital or computed X-ray radiographic radiogrammetry (see fig. 1 and par. [0007]), and estimate a Hip BMD in g/cm2 (see par. [004], [0011], [0059]), Hip BMD in g/cm2 (see par. [004], [0011], [0059]), 10-year probability of Major bones Osteoporotic Fracture Risk Score and 10-year probability of Osteoporotic Hip Fracture Risk Score by employing the calculated Bone Mass Indices of the Region of Interests (see par. [0015], [0049], but fails to explicitly state x-ray image of bilateral clavicle and spine BMD.
Dixon discloses an integrated protocol for diagnosis treatment and presentation of bone mass degradation. Dixon teaches x-ray image of bilateral clavicle (see par. [0015], [0071]) and spine BMD (see par. [0060]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of x-ray image of bilateral clavicle and spine BMD in the invention of Lin, as taught by Dixon, to be able to provide additional fracture risk score in multiple different regions of interest such as clavicle and spine.
Regarding claim 8, Lin disclose the invention substantially as described in the 102 rejection above, furthermore, Lin shows wherein the risk assessment module is configured to output a risk assessment based on calculated T-Score of dual Hips (see par. [0023], [0043], [0051], [0066], [0068]), dual Hips (see par. [0023], [0043], [0051], [0066], [0068]) from the estimated bone mineral density (BMD) of the Hips (see par. [0023], [0043], [0051], [0066], [0068]), dual Hips (see par. [0023], [0043], [0051], [0066], [0068]) by comparing the estimated T-score of dual Hips , dual Hips to a cutoff T-Score values as per World Health Organization (WHO)' Diagnostic criteria (see par. [0023], [0043], [0051], [0066], [0068]) and predicting whether the patient is Normal, having Osteopenia and Osteoporosis (see par. [0023], [0043], [0051], [0066], [0068]), but fails to explicitly state T-score for spine.
Dixon discloses an integrated protocol for diagnosis treatment and presentation of bone mass degradation. Dixon teaches spine T-score (see par. [0016], [0023], [0060])
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of spine T-score in the invention of Lin, as taught by Dixon, to be able to provide additional fracture risk score in multiple different regions of interest such as spine.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US 2023/0029674; hereinafter Lin), in view of Hong et al. (US 2022/0208384; hereinafter Hong).
Regarding claim 9, Lin shows wherein the risk assessment module is configured to output a risk assessment based on estimated fracture risk scores by comparing the estimated fracture risk scores with published threshold values comprising 10-year probability of Major Bones Osteoporotic Fracture Risk Score (see par. [0015], [0048], [0049], [0076]), and 10-year probability of Osteoporotic Hip Fracture Risk Score (see par. [0015], [0048], [0049], [0076]) and determining the high future risk for Osteoporotic fracture (see par. [0015], [0048], [0049], [0076]), but fails to explicitly state score great/equal to 10 for major bones risk score and risk score greater/equal to 3 for hip fracture risk score.
Hong discloses a method and apparatus of predicting fracture risk. Hong teaches score great/equal to 10 for major bones risk score (see table 1 and 5; par. [0149]) and risk score greater/equal to 3 for hip fracture risk score (see table 1 and 5; par. [0149], [0155]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of score great/equal to 10 for major bones risk score and risk score greater/equal to 3 for hip fracture risk score in the invention of Lin, as taught by Hong, to be able to provide an improved and accurate fracture risk prediction method.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
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