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 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 radiographic image acquisition unit that acquires..” in claim 1.
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.
The “radiographic image acquisition unit” has been interpreted as corresponding to a processor, as set forth in paragraphs [0046] and [0115] of Applicant’s PG-Pub 2025/0127474, along with the algorithm/steps for performing the respective function described in the specification, 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 1-7 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.
With regards to claim 1, in the last line, the limitation “each age” is recited, which renders the scope of the claim indefinite as it is unclear as to which age or range/group of ages the term “each” age is referring to. For examination purposes, Examiner assumes “each” age is referring to an age of the subject or an elderly age range.
With regards to claim 7, line 3 refers to “radiation”. It is unclear as to whether the “radiation” is referring to the emitted radiation, as set forth in line 2 of claim 1 or is referring to the detected radiation which has passed through the subject. For examination purposes, Examiner assumes the latter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3 and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. (US Pub No. 2018/0368729) in view of Kitamura et al. (US Pub No. 2008/0232668) and Mitchell et al. (“Associations between obesity and overweight and fall risk, health status and quality of life in older people”, 2014), or, as an alternative to Mitchell et al., in view of Yang et al. (“Relationship between muscle strength and fall episodes among the elderly: the Yilan study”, Taiwan, 2018),
With regards to claim 1, Wilson et al. disclose a radiography system, comprising:
a radiation source (126) for emitting radiation (paragraph [0053], referring to the x-ray source (126); Figure 1);
a first radiation detector (i.e. “detection elements for detecting high energy radiation”) and a second radiation detector (“detection elements for detecting low energy radiation”) that detect radiation which has passed through a subject (paragraph [0057], referring to the detector (130) including detection elements for detecting high energy radiation and detection elements for detecting low energy radiation ; Figure 1, note that the detector (130) is arranged in an irradiation direction of radiation transmitted through a subject; Figure 1);
a radiographic image acquisition unit (i.e. computer) that acquires a first radiographic image (i.e. low energy data) which has been detected by the first radiation detector by transmitting the radiation through the subject, and a second radiographic image (i.e. high energy data) which has been detected by the second radiation detector by transmitting the radiation through the subject and the first radiation detector, the second radiographic image having a different energy distribution from the first radiographic image (paragraphs [0018], [0052], [0057], [0104]-[0105],referring to dual-energy x-ray absorptiometry (DXA), wherein images are acquired having different energy distributions (i.e. low energy radiation, high energy radiation; paragraph [0120], referring to performing dual energy x-ray absorptiometry scan of a patient using a dual-energy absorptiometry system so as to acquire a plurality of dual energy x-ray absorptiometry data; Figures 1, 4, 13); and
at least one processor (“computer”; paragraph [0121]; Figure 14), wherein the at least one processor is configured to:
generate a soft part image representing a soft part region with soft tissue (i.e. lean tissue and/or fat tissue) of the subject from the first radiographic image (i.e. low energy data) and the second radiographic image (i.e. high energy data) (paragraph [0061], referring to the obtained images dividing the body into three components: fat tissue, lean tissue, and bone mineral content, wherein systems that emit dual energies during an imaging or scanning sequences may be utilized to identify a maximum of two of those components at a time (i.e. fat tissue and lean tissue, thereby providing a “soft part image”); paragraph [0113]; Figures 4 and 13);
specify a predetermined part of the subject which is an imaging part of the subject and is included in the first radiographic image and the second radiographic image (paragraphs [0079], [0081], referring to including “one the skeletal muscle pixels” (i.e. predetermined part); paragraph [0113], referring to the image depicting muscle mass in individual limbs (i.e. predetermined part));
derive a muscle mass of the subject in the predetermined part based on pixel values of the soft part region of the soft part image corresponding to the predetermined part (paragraph [0018], referring to processing the plurality of dual energy x-ray absorptiometry data to determine an estimate of the patient’s muscle mass; paragraphs [0071], [0079], [0081], [0086] referring to determining muscle mass of a patient, wherein lean mass can be measured on a pixel-by-pixel basis; Figure 6A);
acquire correspondence information for identifying an affection risk or a disease level of the predetermined disease (i.e. “a patient diagnosis of the frailty syndrome” and/or obesity) of the subject, or a fall rate of the subject (paragraphs [0114]-[0115]; Figure 10, wherein Figure 10 depict a three-dimensional coordinate system plot (1000) where lean muscle mass is plotted on the y-axis (1004) while obesity is plotted on the z-axis (1006), and the plot can be used to determine a patient diagnosis of the frailty syndrome, and thus the plot represents the “correspondence information”); and
specify the affection risk or the disease level of the predetermined disease of the subject, or the fall rate of the subject, from the derived muscle mass (i.e. data point H would include derived muscle mass for the particular patient) of the subject in the predetermined part and a correspondence relationship information (i.e. plot depicted in Figure 10 which depicts a plot correlating lean muscle mass (1004 on the y-axis) and obesity (1006 on the z-axis)) (paragraphs [0114]-[0115], referring to the data point H which represents data obtained from a particular patient and can be used to determine if the particular patient has obesity and/or frailty syndrome; Figure 10), wherein:
in a case of specifying the affection risk or the disease level of the predetermined disease of the subject, the correspondence relationship information (i.e. plot depicted in Figure 10) is disease information (i.e. obesity or frailty syndrome) that represents the correlative relationship between the risk or disease level of the predetermined disease (i.e. obesity in the z-axis 1006) and the muscle mass (i.e. lean mass in the y-axis 1004) of the predetermined part (paragraphs [0114]-[0115]; Figure 10, wherein Figure 10 depict a three-dimensional coordinate system plot (1000) where lean muscle mass is plotted on the y-axis (1004) while obesity is plotted on the z-axis (1006), and the plot can be used to determine a patient diagnosis of the frailty syndrome, and thus the plot represents the “correlative relationship”).
However, Wilson et al. do not specifically disclose that the first radiation detector and the second radiation detector are superimposed in an irradiation direction of radiation emitted from the radiation source and that the processor is further configured to acquire the first radiographic image and the second radiographic image by a one-shot radiation from the radiation source.
Further, though Wilson et al. disclose that the correspondence relationship information is information that represents the correlative relationship between obesity and the muscle mass of the predetermined part (paragraphs [0114]-[0115]; Figure 10), Wilson et al. do not specifically disclose that in a case of specifying the fall rate of the subject, the correspondence relationship information is information that represents the correlative relationship between the fall rate for each age and the muscle mass of the predetermined part.
Kitamura et al. disclose obtaining three radiographic images which are formed by radiation transmitted through a subject and represent degrees of transmission of three patterns of radiations having different energy distributions through the subject (Abstract; paragraph [0012]). The radiographic images may be obtained in a three shot method in which imaging is carried out three times using three patterns of radiations having different energy distributions, or may be obtained in a one shot method in which radiation is applied once to three storage phosphor sheets stacked one on the other via additional filters such as energy separation filters so that radiations having different energy distributions are detected on the three sheets, wherein other means such as flat panel detector (FPD) may be appropriately selected and used for detecting the radiation as an alternative to using the storage phosphor sheet (paragraph [0012], note that stacked flat panel detectors would encompass at least a first radiation detector and second radiation detector that are superimposed in an irradiation direction of radiation emitted from the radiation source).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to substitute the radiation detectors of Wilson et al. with radiation detectors comprising of the first radiation detector and the second radiation detector being superimposed in an irradiation direction of radiation emitted from the radiation source, which provides the first radiographic image and the second radiographic image by a one-shot radiation from the radiation source, as taught by Kitamura et al., as the substitution of known radiation detectors for another yields predictable results (i.e. providing radiation images having different energy distributions) to one of ordinary skill in the art and further “stacked” detectors is a known alternative design for a multi-energy scanning system (paragraph [0012]). One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
However, the above combined references do not specifically disclose that in a case of specifying the fall rate of the subject, the correspondence relationship information is information that represents the correlative relationship between the fall rate for each age and the muscle mass of the predetermined part.
Mitchell et al. disclose a study examining the influence of obesity and overweight on fall risk and factors influencing fall risk in obese and overweight individuals compared to those of a healthy weight (Abstract; pg. 15, “Discussion”). The study demonstrated an association between increasing BMI and risk of falls (i.e. fall rate) (pg. 15, “Discussion”; Tables 1-5, note that, as indicated in the tables, the fall risks/rate is provided for different age groups (i.e. 65-74, 75-84, 85+)). Such information may be useful in identifying high-risk fall groups that could be targeted for prevention efforts at the population level (pg. 13, right column, 1st full paragraph).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to, in a case of specifying the fall rate of the subject, modify the correspondence relationship information of the above combined references to include information that represents the correlative relationship between the fall rate for each age and the muscle mass of the predetermined part [wherein the fall rate, as taught by Mithcell et al., is specified based on obesity, which, as disclosed by Wilson et al., is ultimately specified based on the derived muscle mass and the derived bone mineral content, and therefore a correlative relationship in the modification exists between the fall rate (correlated to the obesity as presented in Figure 10 of Wilson et al.) for each age and the muscle mass], as taught by Mitchell et al., in order to identify high-risk fall groups that could be targeted for prevention efforts at the population level (pg. 13, right column, 1st full paragraph).
Alternatively to Mitchell et al.:
Yang et al. disclose a correlation between muscle strength, muscle mass and risk factors of fall episode(s) in an elderly population (Abstract, pg. 2, left column, 3rd paragraph; Conclusion; Tables 1-3, for example, Table 1 correlates muscle mass/strength to number of falls episodes within the past year (i.e. fall rate) and age). Future falls and even fractures can be identified (pg. 2, left column, 2nd paragraph).
Therefore, as an alternative to Mitchell et al., before the effective filing date of the claimed invention, in a case of specifying the fall rate of the subject, it would have been obvious to one of ordinary skill in the art to modify the correspondence relationship information of the above combined references include information that represents the correlative relationship between the fall rate for each age and the muscle mass of the predetermined part, as taught by Yang et al., in order to identify future falls and fractures (pg. 2, left column, 2nd paragraph).
With regards to claim 2, Wilson et al. disclose that the at least one processor generates a muscle mass distribution image representing a distribution of the muscle mass based on the derived muscle mass of the predetermined part (paragraph [0104], referring to the images providing visual representations of information, such as lean mass; paragraph [0113], referring to an image that depicts relative differences in muscle mass of individual limbs being presented, wherein such an image corresponds to a muscle mass distribution image).
With regards to claim 3, Wilson et al. disclose that the system further comprises a display unit (822) wherein the at least one processor is configured to display the generated muscle mass distribution image on the display unit (paragraphs [0060], [0100], [0104], referring to displaying of the images, including images providing visual representations of information, such as lean mass; paragraph [0113], referring to presenting/displaying the image that depicts relative differences in muscle mass of individual limbs being presented, wherein such an image corresponds to a muscle mass distribution image; Figure 8).
With regards to claim 5, Wilson et al. disclose that in a case of specifying the affection risk or the disease level of the predetermined disease of the subject, the predetermined disease is sarcopenia (paragraphs [0063], [0096]-[0099], [0103], [0109], referring to the diagnosis of sarcopenia; Figures 8-11), the predetermined part is a part of a limb or a part of a whole body (paragraph [0113], referring to the image depicting muscle mass in individual limbs (i.e. predetermined part); paragraphs [0079], [0081], referring to including “one the skeletal muscle pixels” (i.e. predetermined part)), and the disease information is the disease level of the sarcopenia (paragraph [0109], referring to graphs being used to determine if a patient’s data point (i.e. C,D) is closer to the sarcopenic range defined by curve S, which corresponds to a disease level of sarcopenia; paragraph [0115], referring to patient data point (i.e. I) being scaled to denote severity/level of a condition, such as sarcopenia; Figures 8-11).
With regards to claim 6, Wilson et al. disclose that the at least one processor is configured to generate a bone part image representing a bone part region with a bone tissue of the subject from the first radiographic image and the second radiographic image (paragraphs [0061]-[0062], referring to images dividing the body into three components: “fat tissue, lean (“lipid-free soft tissue”) tissue, and bone mineral content (“BM[I]C”)”; paragraph [0120], referring to “The processing operation of operation 1308…may include computer processing the plurality of dual energy x-ray absorptiometry data to determine an estimate of…”the patient’s bone mineral density, the patient’s muscle mass, and/or the patient’s adipose tissue (all objective measurements)”; paragraphs [0113]-[0114]; Figure 4), and derive a bone mineral content based on a pixel value for each pixel of the bone part region of the bone part image (paragraph [0120], referring to “The processing operation of operation 1308…may include computer processing the plurality of dual energy x-ray absorptiometry data to determine an estimate of…”the patient’s bone mineral density, the patient’s muscle mass, and/or the patient’s adipose tissue (all objective measurements)”; paragraphs [0113]-[0114]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. in view of Kitamura et al. and Mitchell et al. (or Yang et al.), as applied to claim 1 above, and further in view of Fuhrmann et al. (US Pub No. 2011/0113863).
With regards to claim 4, as discussed above, the above combined references meet the limitations of claim 1.
Further, Wilson et al. disclose that in a case of specifying the affection risk or the disease level of the predetermined disease of the subject, the predetermined part is a lower limb (paragraph [0064], referring to muscle mass measurement in the legs (i.e. lower limb)), the predetermined disease is a condition, such as obesity (paragraphs [0114]-[0115]; Figures 10, 11B), and the disease information is the affection risk of the condition, such as obesity (paragraphs [0114]-[0115], Figures 10, 11B).
However, Wilson et al. do not specifically disclose that the predetermined disease is diabetes.
Fuhrmann et al. discloses diagnostic methods for diabetes and body lean mass, wherein a low body mass is an indicator for an increased predisposition for diabetes and/or obesity (Abstract; paragraph [0082]). Body lean mass can be readily and reliably determined and changes which affect a subject’s risk for developing diseases and disorders associated or caused by excessive body storage fat, such as diabetes or obesity, can be closely monitored and the effectiveness of measures counteracting the said risk can be evaluated (paragraph [0084]). Diabetes can be more reliably and efficiently diagnosed and monitored, and consequently, diabetes care can be improved (paragraph [0078]).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the predetermined disease of the above combined references be diabetes, as taught by Fuhrmann et al., in order to provide close monitoring of diabetes and evaluate the effectiveness of measures counteracting the said risk, thereby improving the care of diabetes (paragraphs [0078], [0084]).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al. in view of Kitamura et al. and Mitchell et al. (or Yang et al.) as applied to claim 1 above, and further in view of Nakayama (US Pub No. 2009/0314948).
With regards to claim 7, as discussed above, the above combined references meet the limitations of claim 1.
Kitamura et al. further disclose that the system further comprises a radiation-energy conversion filter that is disposed between the first radiation detector and the second radiation detector (paragraph [0012], referring to the one shot method in which radiation is applied once to three flat panel detectors/sheets stacked one on the other “via additional filters such as energy separation filters” so that radiations having different energy distributions are detected on the three detectors/sheets, wherein such an arrangement of stacked detectors “via” the filters would encompass the filter(s) being disposed between the detectors).
However, the above combined references do not specifically disclose that the radiation-energy conversion filter is specifically a filter that absorbs a specific energy component included in radiation.
Nakayama discloses a radiation image capturing system, wherein the system comprises a filter (26) for adjusting the spectrum of the X-rays output from the target (24) and wherein the filter (26) is made of any one of various materials including MO, Rh, aluminum, etc. which is selected to selectively extract characteristic X-rays in combination with the target (24) (Abstract; paragraph [0030]). The filter (26) selectively absorbs X-rays, such as selectively extracting characteristic X-rays and removing X-rays at high energy levels of 20keV or higher, thereby producing an X-ray spectrum for increased radiation image contrast (paragraphs [0030]-[0031]; Figures 1-2, 6).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have the radiation-energy conversion filter of the above combined references be specifically a filter that absorbs a specific energy component included in radiation, as taught by Nakayama, in order to selectively extract desired characteristic X-rays and thus increase radiation image contrast (paragraphs [0030]-[0031]). Alternatively, it would have been obvious to one of ordinary skill in the art to substitute the radiation-energy conversion filter of the above combined references with a radiation-energy conversion filter that absorbs a specific energy component included in radiation, as taught by Nakayama, as the substitution of one known radiation-energy conversion filter for another yields predictable results (i.e. providing radiation in a selective range) to one of ordinary skill in the art. One of ordinary skill in the art would have been able to carry out such a substitution and the results are reasonably predictable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ruhrnschopf et al. (US Pub No. 2008/0095313) disclose that in dual X-ray absorptiometry, the object to be examined, which is usually a patient, is irradiated by means of X-ray radiation in different energy ranges, whereby the dual X-ray absorptiometry can be effected by means of a single radiograph recording or a series of successively recorded radiographs (paragraph [0006]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE L FERNANDEZ whose telephone number is (571)272-1957. The examiner can normally be reached Monday-Friday 9:00 AM - 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571) 272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE L FERNANDEZ/ Primary Examiner, Art Unit 3798