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 13 and 16 are objected to under 37 CFR 1.75 as being duplicates of claims 12 and 15, respectively. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 2, 3, 9, 10, 11, 12, 13, 15, 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to an abstract idea without significantly more. The phrase “determining an imaging condition in the series of X-ray imaging operations…” is an abstract idea. The “acquiring information…” step is mere data gathering, which does not amount to significantly more (MPEP 2106.5(g)). Including a hardware processor or similar basic computer elements amounts to a mere “apply it” phrase, and does not add limitations that are sufficient to amount to significantly more than the judicial exception.
The remaining claims recite substantially similar limitations and are rejected according to the same rationale for failing to amount to significantly more. See MPEP 2106.05.
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 1-17 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 claims 1-17, the term “information based on a number of times of simple X-ray imaging operations” is considered indefinite because it is unclear precisely what type of information this is. In light of the specification and most of the other claims where this term (or similar related terms) appears, the term seems to simply refer to “the number of times of simple X-ray imaging operations”, rather than a vague “information based on” this number. However, claim 9 recites “the information based on the number of times of simple X-ray imaging operations is information corresponding to at least one of an age of a subject, a sex of the subject, a physique of the subject, a dose in a past X-ray imaging operations of the subject, and a standard dose.” This seems to imply that the “information based on the number of times…” may also be other numeric or even qualitative data. Due to this confusion, claims 1 and 9 are considered indefinite, as are all of the remaining claims for containing this term.
For examination purposes, “information based on a/the number of times of simple X-ray imaging operations” will simply be read as “a/the number of times of simple X-ray imaging operations”. Claim 9 will be read as “the hardware processor further acquires at least one of an age of a subject, a sex of the subject, …”, and that this information is used alongside the acquired “number of times” information in the “determine an imaging condition” function.
Regarding claim 5, there is insufficient antecedent basis for “information based on the number of times of second simple X-ray imaging operations based on the accepted imaging conditions”. For examination purposes, the limitation will be read as “a number of times of second simple X-ray imaging operations based on the accepted imaging conditions”.
Regarding claim 10, “radiology department information system” is unclear because it is not a known term in the art. Rather, “radiology information system (RIS)”, as used in the specification, is the known term. For examination purposes, the limitation will be read as such.
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, 3, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamiya (US 20130077744 A1).
Regarding claim 1, as best understood, Kamiya teaches an imaging control apparatus comprising:
a hardware processor (paragraph [0100]: CPU 100 as part of the console 14 that performs the various functions of the apparatus) that acquires information based on a number of times of simple X-ray imaging operations (paragraph [0120] describes calculating the number N of exposures based on user-provided geometric parameters) as information regarding a continuous imaging dose which is a dose in a series of X-ray imaging operations (Abstract; Note that while this reference is directed to continuous exposure for a subdivided still image rather than for dynamic imaging, this does not conflict with how the functions of the claimed invention are performed),
wherein the hardware processor determines an imaging condition in the series of X-ray imaging operations in accordance with the acquired information based on the number of times of the simple X-ray imaging operations (paragraph [0120] describes determining various other parameters alongside the number N of exposures, some of which e.g. the division exposure positions depend on N).
Regarding claim 3, as best understood, Kamiya teaches the imaging condition in the series of X-ray imaging operations is a condition corresponding to a subject (paragraph [0096]: “an examination order including information about sex and age of the patient, a body part to be imaged, an examination purpose, and the like is inputted from an input device”. Also see Fig. 7).
Regarding claim 9, as best understood, Kamiya teaches the information based on the number of times of simple X-ray imaging operations being information corresponding to at least one of an age of a subject, a sex of the subject, a physique of the subject, a dose in past X-ray imaging operations of the subject, and a standard dose (paragraph [0096] describes information about sex and age of the subject being input as part of an “examination order”, the contents of which are corresponded to numerical imaging conditions).
Regarding claim 11, Kamiya teaches the imaging condition being at least one of a tube voltage, a tube current, a frame rate, and an imaging time (paragraph [0061]).
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamiya (US 20130077744 A1).
Regarding claim 2, as best understood, Kamiya teaches an imaging control apparatus comprising:
a hardware processor (paragraph [0100]: CPU 100 as part of the console 14 that performs the various functions of the apparatus) that acquires information based on a number of times of simple X-ray imaging operations (paragraph [0108] describes calculating the number N of exposures) as information regarding a continuous imaging dose which is a dose in a series of X-ray imaging operations (Abstract),
wherein the hardware processor presents an imaging condition in the series of X-ray imaging operations in accordance with the acquired information based on the number of times of the simple X-ray imaging operations (paragraph [0096] describes displaying examinations orders and imaging conditions on a monitor; it is not explicitly stated that the displayed information is in accordance with the number-of-scans information, but implicitly such information is among that which can be displayed).
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamiya (US 20130077744 A1).
Regarding claim 4, as best understood, Kamiya teaches an imaging control apparatus comprising:
a hardware processor (paragraph [0100]: CPU 100 as part of the console 14 that performs the various functions of the apparatus) that acquires information based on a number of times of simple X-ray imaging operations (paragraph [0108] describes calculating the number N of exposures) as information regarding a continuous imaging dose which is a dose in a series of X-ray imaging operations (Abstract),
wherein the hardware processor accepts an input of an imaging condition in the series of X-ray imaging operations (paragraph [0061]: “The imaging conditions are manually inputted from the touch panel 34 by the radiological technician.”), and
wherein the hardware processor (i) outputs an alert based on information according to the acquired number of times of the first simple X-ray imaging operations and based on the accepted imaging conditions in the series of X-ray imaging operations or (ii) limits setting of the imaging condition or limits the series of X-ray imaging operations (paragraph [0062]: “the imaging condition of the X-ray source 10 has the maximum product value or the maximum irradiation duration, in order to prevent a shortage of the X-ray dose caused by ending the X-ray emission before the judgment by the AEC”).
Claims 12, 13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamiya (US 20130077744 A1).
Regarding claims 12 and 13, Kamiya teaches an imaging control method comprising:
acquiring information based on a number of times of simple X-ray imaging operations (paragraph [0120] describes calculating the number N of exposures based on user-provided geometric parameters) as information regarding a continuous imaging dose which is a dose in a series of X-ray imaging operations (Abstract; Note that while this reference is directed to continuous exposure for a subdivided still image rather than for dynamic imaging, this does not conflict with how the broadly-limited functions of the claimed invention are performed),
wherein an imaging condition in the series of X-ray imaging operations is determined in accordance with the acquired information based on the number of times of the simple X-ray imaging operations (paragraph [0120] describes determining various other parameters alongside the number N of exposures, some of which e.g. the division exposure positions depend on N).
Regarding claims 15 and 16, Kamiya teaches a non-transitory recording medium including a program that controls a computer of an imaging control apparatus to function as, a hardware processor that performs the method according to claims 12 and 13 (Figs. 10-11; paragraph [0100] onwards).
Claims 14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kamiya (US 20130077744 A1).
Regarding claim 14, Kamiya teaches an imaging control apparatus comprising:
acquiring information based on a number of times of simple X-ray imaging operations (paragraph [0108] describes calculating the number N of exposures) as information regarding a continuous imaging dose which is a dose in a series of X-ray imaging operations (Abstract),
accepting an input of an imaging condition in the series of X-ray imaging operations (paragraph [0061]: “The imaging conditions are manually inputted from the touch panel 34 by the radiological technician.”), and
(i) outputting an alert based on acquired information according to the number of times of the simple X-ray imaging operations and based on the accepted imaging condition in the series of X-ray imaging operations or (ii) limiting setting of the imaging condition or limiting the series of X-ray imaging operations (paragraph [0062]: “the imaging condition of the X-ray source 10 has the maximum product value or the maximum irradiation duration, in order to prevent a shortage of the X-ray dose caused by ending the X-ray emission before the judgment by the AEC”).
Regarding claim 17, Kamiya teaches a non-transitory recording medium including a program that controls a computer of an imaging control apparatus to function as, a hardware processor that performs the method according to claim 14 (Figs. 10-11; paragraph [0100] onwards).
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 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Kamiya in view of Tachikawa (JP 2016073508 A).
Regarding claim 5, Kamiya does not teach the hardware processor outputting an alert when information based on the number of times of second simple X-ray imaging operations based on the accepted imaging conditions in the series of X-ray imaging operations exceeds information based on the number of times of the first simple X-ray imaging operations.
In the same field of endeavor, Tachikawa teaches outputting an alert when the next estimated X-ray dose exceeds the previous dose (Abstract). Outputting an alert is a well-known method in the art for reducing risk to the patient by notifying the operator of potential radiation overexposure. In light of the teachings of Tachikawa, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kamiya to output an alert.
Neither Kamiya nor Tachikawa teach this occurring when information based on a number of times of second simple X-ray imaging operations based on the accepted imaging condition in the series of X-ray imaging operations exceeds information based on the number of times of the first simple X-ray imaging operations.
Instead, Kamiya teaches a direct thresholding of an accepted inputted imaging condition by a predetermined maximum (mAs product value or irradiation duration, paragraph [0062]). However, one can convert the accepted imaging condition(s) to “a number of times of second simple X-ray imaging operations based on the accepted imaging condition” by a trivial calculation. For example, it is well-known that the mAs value is proportional to the ESD; this total ESD can be divided by the reference ESD per scan to obtain the “number of times of second simple X-ray imaging operations based on the accepted imaging condition” (the mAs in this case). This can then be limited by the number of scans N (which is independently determined via inputted geometric parameters; see paragraph [0120]) rather than a predetermined maximum on the mAs value. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention could perform a simple substitution of known elements (the inputted mAs value condition, and the predetermined maximum mAs value) for others (the number of scans calculated as proportional to the inputted mAs value, and the number of scans N determined previously) to obtain predictable results (the setting of the imaging condition is controlled by limiting a number-of-scans value obtained from the inputted imaging conditions below the previously acquired number-of-scans value N, and an alert is presented when the number-of-scans value obtained from the inputted imaging conditions exceeds N. Limiting/alerting applied dose is known in the art to reduce patient risk; thresholding based on current-time product, ESD, or number-of-exposures are obvious over one another because they are proportional). See MPEP 2143.
Regarding claim 6, Kamiya teaches the hardware processor acquiring a dose of radiation emitted to a subject and performing an action when the dose exceeds a value smaller than a preset target by a predetermined value (paragraph [0062]).
Kamiya does not teach outputting an alert; this element is obvious over Tachikawa as outlined above.
Neither Kamiya nor Tachikawa teach outputting the alert when information based on a number of times of third simple X-ray imaging operations based on the acquired dose of radiation emitted to the subject exceeds a value smaller than information based on the number of times of the first simple X-ray imaging operations by a predetermined value.
Similar to claim 5, arriving at the claimed invention is a matter of simple substitution by mapping the control parameters of Kamiya to number-of-times information via a simple calculation. The processor can be configured to divide the accumulating dose by the reference ESD per scan to obtain a proxy number-of-scans value, and compare this value to a threshold that is a predetermined value lower than the previously acquired number-of-scans N. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention could perform a simple substitution of known elements (the accumulating X-ray dose of Kamiya, and the “sufficient value” threshold in Kamiya para. [0062]) for others (the number of scans calculated as proportional to the dose, and the number of scans N determined previously minus a predetermined value) to obtain predictable results (the alert is sent when the proxy number-of-scans value reaches a threshold that is a predetermined value less than N. Monitoring applied dose is known in the art to reduce patient risk; thresholding based on current-time product, ESD, or number-of-exposures are obvious over one another because they are proportional). See MPEP 2143.
Claims 7, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Kamiya.
Regarding claim 7, as best understood, Kamiya teaches the hardware processor limiting setting of the imaging condition or limiting the series of X-ray imaging operations (see rejection of claim 4 above).
Kamiya does not teach this occurring when information based on a number of times of second simple X-ray imaging operations based on the accepted imaging condition in the series of X-ray imaging operations exceeds information based on the number of times of the first simple X-ray imaging operations.
Instead, Kamiya teaches a direct limiting of an accepted inputted imaging condition by a predetermined maximum (mAs product value or irradiation duration, paragraph [0062]). However, one can convert the accepted imaging condition(s) to “a number of times of second simple X-ray imaging operations based on the accepted imaging condition” by a trivial calculation. For example, it is well-known that the mAs value is proportional to the ESD; this total ESD can be divided by the reference ESD per scan to obtain the “number of times of second simple X-ray imaging operations based on the accepted imaging condition” (the mAs in this case). This can then be limited by the number of scans N (which is independently determined via inputted geometric parameters; see paragraph [0120]) rather than a predetermined maximum on the mAs value. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention could perform a simple substitution of known elements (the inputted mAs value condition, and the predetermined maximum mAs value) for others (the number of scans calculated as proportional to the inputted mAs value, and the number of scans N determined previously) to obtain predictable results (the setting of the imaging condition is controlled by limiting a number-of-scans value obtained from the inputted imaging conditions below the previously acquired number-of-scans value N. Limiting applied dose is known in the art to reduce patient risk; thresholding based on current-time product, ESD, or number-of-exposures are obvious over one another because they are proportional). See MPEP 2143.
Regarding claim 8, as best understood, Kamiya teaches the hardware processor acquiring a dose of radiation emitted to a subject, and stopping emission of the radiation when the dose exceeds a value smaller than a preset target by a predetermined value (paragraph [0062]: “By automatic exposure control (AEC), an X-ray dose applied to the FPD 40 is measured. When the X-ray dose reaches a sufficient value, the X-ray emission is stopped even if the irradiation duration does not reach a set value”).
Kamiya does not teach that emission is stopped when information based on a number of times of third simple X-ray imaging operations based on the dose of radiation emitted to the subject exceeds a value smaller than information based on the number of times of the first simple X-ray imaging operations by a predetermined value.
Similar to claim 7, arriving at the claimed invention is a matter of simple substitution by mapping the control parameters of Kamiya to number-of-times information via a simple calculation. The processor can be configured to divide the accumulating dose by the reference ESD per scan to obtain a proxy number-of-scans value, and compare this value to a threshold that is a predetermined value lower than the previously acquired number-of-scans N. Therefore, a person of ordinary skill in the art before the effective filing date of the claimed invention could perform a simple substitution of known elements (the accumulating X-ray dose of Kamiya, and the “sufficient value” threshold in Kamiya para. [0062]) for others (the number of scans calculated as proportional to the dose, and the number of scans N determined previously minus a predetermined value) to obtain predictable results (the X-ray emission is stopped when the proxy number-of-scans value reaches a threshold that is a predetermined value less than N. Monitoring applied dose is known in the art to reduce patient risk; thresholding based on current-time product, ESD, or number-of-exposures are obvious over one another because they are proportional). See MPEP 2143.
Regarding claim 10, Kamiya teaches the hardware processor acquiring information from a radiology information system (paragraph [0096]).
Kamiya does not teach information based on the number of times of simple X-ray imaging operations being acquired from the RIS.
A person of ordinary skill in the art could, before the effective filing date of the claimed invention, make a simple substitution of one known element (the information provided by the RIS in Kamiya, which is the sex and age of the patient, body part to be imaged, examination purpose, etc.) for another (the number of exposures N; or, at least, a protocol from the RIS that allows certain sets of geometric parameters to be mapped to N as in paragraph [0120]) to obtain predictable results (the RIS provides the number-of-exposures information to the hardware processor rather than having to calculate it locally, streamlining the examination preparation process). See MPEP 2143.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM L TAYLOR whose telephone number is (571)272-8389. The examiner can normally be reached Mon-Fri, 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Makiya can be reached at (571) 272-2273. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM LAURENCE TAYLOR/Examiner, Art Unit 2884
/DAVID J MAKIYA/Supervisory Patent Examiner, Art Unit 2884
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