tDETAILED 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 .
Specification
The disclosure is objected to because para. 53 lacks clarity. Para. 53 reads “If the length in time of a scanning protocol falls below the breath-holding duration, information in respect of the MR scan in question is output. Alternatively, or additionally, the length in time of the MR scan in question may be adapted automatically. This may be done by shortening a scanning protocol or dividing a scanning protocol into multiple parts …”. The shortening a scanning protocol implies that the scanning protocol is too long for the breath-holding duration, not the other way around. That is, if the breath-holding duration falls below the length in time of a scanning protocol, then shortening a scanning protocol or dividing a scanning protocol may be done.
Claim Objections
Claims 8-9. 13, and 16-17 are objected to because of the following informalities:
In claim 8, lines 5-6, “a respiratory signal” should read “the respiratory signal”.
In claim 9, “a time of suspension” should read “the time of suspension of breathing” because the “time of suspension of breathing” is in claim 5.
In claim 13, lines 2-3, the “are checked” should be deleted because the claim recites “checking” in line 2.
In claim 16, lines 1-2, the “multiple breath-holding MR scans on a patient” should read “multiple breath-holding MR scans on the patient including the breath-holding MR scan” or “additional breath-holding MR scans on the patient”, for example.
In claim 17, line 3, the “a PMU system” should read “a system for physiological monitoring of the patient (PMU)”, for example.
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 PMU system configured to…” and “a determination unit configured to…” in claim 17. Interpreted as one or more cooperating microprocessors with software [0034].
“an output unit configured to …” in claim 17. Interpreted as a data interface [0077].
“a protocol unit…” in claim 18. Interpreted as one or more cooperating microprocessors with software [0034].
“a control device…” in claim 19. Interpreted as one or more cooperating microprocessors with software [0034].
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 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 § 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 1-7 and 17-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Although the claims fall within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter), claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection as judicial exceptions.
Regarding claim 1, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “determining a respiratory behavior of the patient for the breath-holding MR scan from the respiratory signal” and “outputting information about the respiratory behavior and/or outputting control commands based on the respiratory behavior” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “acquiring a respiratory signal from a patient during a breath-holding MR scan”, which are the steps of pre-solution data gathering. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 1 is therefore non-statutory and not patent eligible.
Regarding claim 2, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “establishing a scanning protocol of an MR scan based on the information about the respiratory behavior of the patient”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 2 is therefore non-statutory and not patent eligible.
Regarding claim 3, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “wherein the information about the respiratory behavior originates from a previous MR examination on the patient, originates from a previous MR scan of an MR examination with a plurality of MR scans, or a combination thereof”, which is further limiting the pre-solution data gathering. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 3 is therefore non-statutory and not patent eligible.
Regarding claim 4, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the determining of the respiratory behavior comprises creating a respiratory curve from a strength of the respiratory signal against time and determining the respiratory behavior from the respiratory curve”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 4 is therefore non-statutory and not patent eligible.
Regarding claim 5, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the determining of the respiratory behavior comprises a determination of a time of suspension of breathing, a breath-holding duration, a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 5 is therefore non-statutory and not patent eligible.
Regarding claim 6, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein, in an event that the breath-holding duration is below a predefined limit value, information is output that the patient has not held his or her breath for long enough”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 6 is therefore non-statutory and not patent eligible.
Regarding claim 7, the claim is directed to a method and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim and the “wherein the multiple respiratory curves are compared with a reference respiratory profile”, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites no additional elements. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 7 is therefore non-statutory and not patent eligible.
Regarding claim 17, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “determine a respiratory behavior of the patient for the breath-holding MR scan from the respiratory signal” and “output information about the respiratory behavior and/or outputting control commands based on the respiratory behavior” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements “a determination unit configured to determine …; a PMU system configured to acquire a respiratory signal from a patient during a breath-holding MR scan; an output unit configured to output …”, which are the steps of pre-solution data gathering and mere instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 17 is therefore non-statutory and not patent eligible.
Regarding claim 18, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of the base claim, which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements the “protocol unit configured to adapt a scanning protocol for an MR scan based on the respiratory behavior from one or more previous MR scans”, which is insignificant post-solution activity and mere instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 18 is therefore non-statutory and not patent eligible.
Regarding claim 19, the claim is directed to a device and therefore falls within one of the four enumerated categories of patentable subject matter recited in 35 U.S.C. 101 (i.e., process, machine, manufacture, or composition of matter).
However, the claim recites the steps of “determine a respiratory behavior of the patient for the breath-holding MR scan from the respiratory signal” and “output information about the respiratory behavior and/or outputting control commands based on the respiratory behavior” which, under their broadest reasonable interpretation, encompass a step that can practically be performed in the mind or with the aid of pen/paper. The steps are therefore deemed to recite a mental process type abstract idea.
The claim recites additional elements the “magnetic resonance tomography (MRT) system comprising: a control device configured to: acquire a respiratory signal from a patient during a breath-holding magnetic resonance (MR) scan”, which are the steps of pre-solution data gathering and mere instructions to implement the abstract idea on a computer. Therefore, this judicial exception is not integrated into a practical application.
For similar reasons set forth above with respect to integration, the claim’s additional elements do not confer an inventive concept that amount to significantly more. Claim 19 is therefore non-statutory and not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as a single means claim. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 recites the “control device configured to: …”. Claim 19 uses 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.
A single means claim, i.e., where a means recitation does not appear in combination with another recited element of means, is subject to an enablement rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714-715, 218 USPQ 195, 197 (Fed. Cir. 1983) (A single means claim which covered every conceivable means for achieving the stated purpose was held nonenabling for the scope of the claim because the specification disclosed at most only those means known to the inventor.). See MPEP 2164.08a.
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 3, 9, and 12-13 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 pre-AIA the applicant regards as the invention.
Claim 3 recites the “from a previous MR examination on the patient, ... originates from a previous MR scan of an MR examination with a plurality of MR scans” in lines 2-3. The relationship between this recitation and the breath-holding MR scan in claim 1 is unclear because the information about the respiratory behavior originates from the breath-holding MR scan in claim 1, not from previous MR examination(s) or scans. It is therefore unclear whether previous MR examination(s) or scans are additional source of information or the breath-holding MR scan of claim 1 is one of the previous scans. For examination purposes, Examiner of record takes this to be “from a previous MR examination on the patient comprising the breath-holding MR scan… originates from a previous MR scan of an MR examination with a plurality of MR scans comprising the breath-holding MR scan”.
Claim 9 recites the “wherein the period of time is a time of suspension”. This recitation is unclear because a time of suspension is a point in time rather than a period of time. Additionally, this recitation contradicts to the definition of the period of time in claim 8 as a period of time between the time of the respiratory command and a reaction by the patient in which a respiratory signal following on from the respiratory command. Furthermore, the relationship between this recitation and a time of suspension of breathing in claim 5 is unclear.
Claim 12 recites the “gradient of the respiratory signal” in line 2. The relationship between this recitation and the “gradient of a respiratory curve” in claim 5 is unclear. For examination purposes, Examiner of record takes this to be “the gradient of the respiratory curve”.
Claim 12 recites the “scan” in line 2. The relationship between this recitation and the “breath-holding MR scan” in claim 1 is unclear. For examination purposes, Examiner of record takes this to be “the breath-holding MR scan”.
Claim 13 recites the “checking scanning protocols of subsequent MR scans of the examination … for their length in time when the breath-holding duration lies below a predefined limit value; and outputting information in respect of the MR scan in question and/or automatically adapting the length in time of the MR scan in question when the length in time of a scanning protocol falls below the breath-holding duration”. The “when the breath-holding duration lies below a predefined limit value” implies that the breath-holding duration is too short while the “when the length in time of a scanning protocol falls below the breath-holding duration” implies that the length in time of a scanning protocol is even shorter. It is unclear why the length in time of a scanning protocol falls below the breath-holding duration when it is the breath-holding duration that lies below a predefined limit value. For examination purposes, Examiner of record takes the “automatically adapting” to be “automatically adapting the length in time of the MR scan in question when the breath-holding duration falls below the length in time of a scanning protocol”.
Claims dependent upon the rejected claims above, but not directly addressed, are also rejected because they inherit the indefiniteness of the claim(s) they respectively depend upon.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-7, 13, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zeller (US 20180031665), hereinafter Zeller.
Regarding claim 1, Zeller teaches a method for monitoring and/or adapting breath-holding magnetic resonance (MR) examinations (Abstract. “Based on the acquired MR measurement data and depending on the detected next-breath time, a final MR measurement data set DSf is created (block 209) from which image data BD can be reconstructed (block 213). If the acquisition of the MR measurement data was cancelled as soon as a next-breath time was detected (Cancel? 207 “y”), the final MR measurement data set comprises the MR measurement data acquired before detection of the next-breath time, i.e. the MR measurement data of the first data set DS1.” [0041]; Fig. 2. “The MR measurement data in the first data set DS1 acquired before detection of the next-breath time WAZ contain no interfering influences due to the resuming respiratory movement and are thus suitable as a basis for a reconstruction kernel used.” [0044]; Figs. 1 and 4), the method comprising:
acquiring a respiratory signal (AK) from a patient during a breath-holding MR scan (“detection of the next-breath time WAZ” [0054]. “The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061]; Fig. 1);
determining a respiratory behavior of the patient for the breath-holding MR scan from the respiratory signal (“the determined breath-holding capacity of the patient” [0057]); and
outputting information about the respiratory behavior and/or outputting control commands (AAH) based on the respiratory behavior (“If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data. Depending on the sequence to be performed, parameters to be adapted here may be: a repetition time TR, a number of breath-holding states needed in total, a number of required averagings, a recording matrix size, or a parallel acceleration factor.” [0057]; Fig. 2).
Regarding claim 2, Zeller teaches the method of claim 1, further comprising: establishing a scanning protocol of an MR scan based on the information about the respiratory behavior of the patient (“At least one final MR measurement data set is created based on the acquired MR measurement data, depending on the detected next-breath time.” Abstract; “An instruction is given to the patient to hold his/her breath, and the acquisition of MR measurement data is then started. A breathing curve is recorded at least after the instruction to the patient. A next-breath time is detected based on the recorded breathing curve. At least one final MR measurement data set is created in a processor based on the acquired MR measurement data, depending on the detected next-breath time.” [0005]; “If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data.” [0057]; Fig. 2).
Regarding claim 4, Zeller teaches the method of claim 1, wherein the determining of the respiratory behavior comprises creating a respiratory curve (AK) from a strength of the respiratory signal against time (“FIG. 1 is a diagram that illustrates a breathing curve depending on a scan time.” [0016] “The breathing curve is recorded preferably by capturing MR signals in the center of k-space at a number of points in time and extracting the phase portion of the captured MR signal.” [0028]; “If a determination is made in the spatial domain, a weighted averaging can be carried out. For example, points outside the body (associated with high level of noise) can be excluded and a weighting can be carried out, for example according to signal intensity.” [0030]; “the value of the breathing curve AK over time” [0032]; Fig. 1) and determining the respiratory behavior from the respiratory curve (“The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061]; Fig. 1).
Regarding claim 5, Zeller teaches the method of claim 1, wherein the determining of the respiratory behavior comprises a determination of a time of suspension of breathing (“the start time of the breath-holding state of the patient” [0029]), a breath-holding duration (“the determined breath-holding capacity of the patient” [0057]), a gradient of a respiratory curve, variations in a case of multiple respiratory curves, or a combination thereof (“The breathing curve is determined preferably by capturing the MR signal using a body coil, applying a Fourier transformation and determining a signal-weighted sum of the signal phases for each readout time interval. In this way, a smoother breathing curve can be recorded, with which a more precise prediction of the start time of the breath-holding state of the patient can be predicted.” [0029]).
Regarding claim 6, Zeller teaches the method of claim 5, wherein, in an event that the breath-holding duration is below a predefined limit value, information is output that the patient has not held his or her breath for long enough (“However, patients cannot always follow the given instructions to the extent desired. Normally, a patient is asked to hold his/her breath for a period of approximately 15 to 20 seconds. Many patients are unable to hold their breath for sufficiently long.” [0003]; “If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient,” [0057]).
Regarding claim 7, Zeller teaches the method of claim 5, wherein the multiple respiratory curves are compared with a reference respiratory profile (“the respiratory cycle of the patient can be used before the time of the intended breath-hold period of the patient, optionally as reference data and/or calibration data for the following detection step” [0007]. “Comparison of the absolute values of the phase values of the captured MR signals with a reference value.” [0037]; “threshold values or reference values can be determined for example through a learning phase upstream of the imaging process, wherein the breathing pattern of the patient concerned is examined by a prerecording of a breathing curve.” [0038]; “The breathing analysis processor 40 can be, for example, part of a control computer of a magnetic resonance imaging system (see FIG. 4). The breathing analysis processor 40 has a raw-data-capture unit 41, which receives raw data, in this exemplary embodiment navigator-k-space data NKRD that have been recorded in the course of a navigator acquisition. The raw data NKRD are transmitted to a phase-value determination unit 42, which extracts phase values PHW from the raw data NKRD. The phase values PHW are then transferred to a respiratory movement determination unit 43. The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061] Fig. 3. It is implied that the “reference values” are for multiple respiratory curves).
Regarding claim 13, Zeller teaches the method of claim 5, further comprising:
checking scanning protocols of subsequent MR scans of the examination are checked for their length in time (“a breath-holding duration with which the process of acquisition of MR measurement data was planned” [0057]) when the breath-holding duration lies below a predefined limit value (below a value of the “breath-holding duration with which the process of acquisition of MR measurement data was planned” [0057]); and
outputting information in respect of the MR scan in question and/or automatically adapting the length in time of the MR scan in question when the length in time of a scanning protocol falls below the breath-holding duration (“In addition, or as an alternative, to the measures already mentioned, the breath-holding capacity of the patient can be determined, e.g. as part of the creation of the final MR measurement data set in block 209, after detection of the next-breath time. This can be done, for example, simply by determining the time that has elapsed between the output of the instruction AAH to the patient to hold his/her breath and the detection of the next-breath time WAZ. If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data.” [0057]).
Regarding claim 17, Zeller teaches a device for monitoring and/or adapting breath-holding magnetic resonance (MR) examinations (Fig. 4), the device comprising:
a PMU system (43) configured to acquire a respiratory signal from a patient (“O”) during a breath-holding MR scan (“detection of the next-breath time WAZ” [0054]. “The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061]; Figs. 1, 4);
a determination unit (43) configured to determine a respiratory behavior of the patient from the respiratory signal (“the determined breath-holding capacity of the patient” [0057]; “The respiratory movement determination unit 43 furthermore has a detection device 43b, which determines, on the basis of the captured breathing curve AK, the next-breath time WAZ, at which the patient starts to continue breathing again after a breath-holding phase” [0061]; Fig. 2); and
an output unit (9) (40) configured to output information about the respiratory behavior and/or to output control commands (AAH) based on the respiratory behavior (“The breathing analysis processor 40 furthermore has a command output unit 45 for automatically emitting an instruction AAH as an output to the patient O to hold his/her breath.” [0061]; Fig. 4) (“If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data. Depending on the sequence to be performed, parameters to be adapted here may be: a repetition time TR, a number of breath-holding states needed in total, a number of required averagings, a recording matrix size, or a parallel acceleration factor.” [0057]; “The central control computer 13 can be operated via a terminal with an input unit 10 and a display unit 9, via which the entire MR system 1 can thus also be operated by an operator. MR images can also be displayed on the display unit 9, and with the input unit 10, optionally in combination with the display unit 9, measurements can be planned and started, and suitable control protocols with suitable measurement sequences, as explained above, are selected and optionally modified.” [0066]; Fig. 4).
Regarding claim 18, Zeller teaches the device of claim 17, further comprising:
a protocol unit (13) configured to adapt a scanning protocol for an MR scan based on the respiratory behavior from one or more previous MR scans (“If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data. Depending on the sequence to be performed, parameters to be adapted here may be: a repetition time TR, a number of breath-holding states needed in total, a number of required averagings, a recording matrix size, or a parallel acceleration factor.” [0057]; “The central control computer 13 can be operated via a terminal with an input unit 10 and a display unit 9, via which the entire MR system 1 can thus also be operated by an operator. MR images can also be displayed on the display unit 9, and with the input unit 10, optionally in combination with the display unit 9, measurements can be planned and started, and suitable control protocols with suitable measurement sequences, as explained above, are selected and optionally modified.” [0066]; Fig. 4).
Regarding claim 19, Zeller teaches a magnetic resonance tomography (MRT) system (1) (Fig. 4) comprising:
a control device (13) (“The central control computer 13 can be operated via a terminal with an input unit 10 and a display unit 9, via which the entire MR system 1 can thus also be operated by an operator. MR images can also be displayed on the display unit 9, and with the input unit 10, optionally in combination with the display unit 9, measurements can be planned and started, and suitable control protocols with suitable measurement sequences, as explained above, are selected and optionally modified.” [0066]; Fig. 4) configured to:
acquire a respiratory signal (AK) from a patient (“O”) during a breath-holding magnetic resonance (MR) scan (“detection of the next-breath time WAZ” [0054]. “The respiratory movement determination unit 43 has a breathing curve recording unit 43a, which is configured to record, based on the received phase values PHW, in real time a breathing curve AK of a patient to be examined.” [0061]; Figs. 1 and 4);
determine a respiratory behavior of the patient from the respiratory signal (“the determined breath-holding capacity of the patient” [0057]); and
output information about the respiratory behavior and/or output control commands (AAH) based on the respiratory behavior (“If the determined breath-holding capacity of the patient deviates from a breath-holding duration with which the process of acquisition of MR measurement data was planned, to such an extent that difficulties with the measurement procedure can be expected (query 211′ “y”), the entire measurement can be started with parameters adapted to the determined breath-holding capacity of the patient, i.e. a new instruction AAH is given to the patient to hold his/her breath and the acquisition of the MR measurement data is performed with adapted parameters and a final MR measurement data set is created from the acquired MR measurement data. Depending on the sequence to be performed, parameters to be adapted here may be: a repetition time TR, a number of breath-holding states needed in total, a number of required averagings, a recording matrix size, or a parallel acceleration factor.” [0057]; Fig. 2).
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Zeller as applied to claim 2, and further in view of Alberts et al (US 20240407738), hereinafter, Alberts.
Regarding claim 3, Zeller teaches the method of claim 2.
Zeller does not teach that the information about the respiratory behavior originates from a previous MR examination on the patient, originates from a previous MR scan of an MR examination with a plurality of MR scans, or a combination thereof.
However, in the MR imaging field of endeavor, Alberts discloses a respiratory state alignment in MRI, which is analogous art. Alberts teaches that the information about the respiratory behavior originates from a previous MR examination on the patient, originates from a previous MR scan of an MR examination with a plurality of MR scans, or a combination thereof (“in the same imaging session or in a previous imaging session, respiratory information and associated imaging data may already have been acquired, and this information may be used to determine a reference respiratory state of interest, such as the maximum exhale (e.g. typically most stable for planning a therapy) or a mid-position (e.g. the point where a volume of interest is in its position where it is found statistically on average over a breath cycle, which may be most representative for planning a therapy).” [0094]).
Therefore, based on Alberts’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller to have the information about the respiratory behavior that originates from a previous MR examination on the patient, originates from a previous MR scan of an MR examination with a plurality of MR scans, or a combination thereof, as taught by Alberts, in order to improve MR scans of the patient by adjusting MR examination protocols based on previously obtained data.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zeller as applied to claim 5, and further in view of Nagasawa et al (US 20170052239), hereinafter, Nagasawa.
Regarding claim 8, Zeller teaches the method of claim 5, further comprising:
acquiring one or more parameters of a respiratory command by a person on the patient (“the start time of the breath-holding state of the patient” [0029]); and
determining at least a time of the respiratory command (AAH)(“determining the time that has elapsed between the output of the instruction AAH to the patient to hold his/her breath and the detection of the next-breath time WAZ.” [0057]; The navigator-sequence generating unit 46 can transmit a trigger signal AS1 to the command output unit 45 in order to prompt the command output unit 45 to emit a breath-hold command AAH automatically, in this case, after the navigator pulse sequence NPS has been activated. Other times for the activation of the breath-hold command AAH are also possible. For example, the breath-hold command can also be emitted chronologically before the navigator pulse sequence NPS is activated.” [0061]).
Zeller does not teach determining a period of time between the time of the respiratory command and a reaction by the patient in which a respiratory signal following on from the respiratory command, wherein, when the period of time is longer than a predefined comparison period, information is output that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time.
However, in the MR imaging field of endeavor, Nagasawa discloses a system and method for automatic start time adjustment in multi-phase scanning, which is analogous art. Nagasawa teaches determining a period of time (“a specific time … a time lag…Td” [0151]) between the time of the respiratory command and a reaction by the patient in which a respiratory signal following on from the respiratory command (“Moreover, when the subject holds his/her breath in response to the breath-hold message a2, it may take a specific time for the subject to react the breath-hold message a2 and hold his/her breath. Therefore, to start the scan SC3 after the subject has surely held his/her breath, a lower limit value of TD2′ may be defined so that a specific interval is placed between the breath-hold message a2 and scan SC3 on account of a time lag in the subject's breath-hold. FIG. 13 schematically shows a lower limit value of the delay time TD2′ in case that a specific interval Td is placed between the breath-hold message a2 and scan SC3. By placing the interval Td, the scan SC3 can be prevented from starting before the subject completes breath-holding. Further, both of the intervals Tc and Td may be placed in the delay time TD2′.” [0151]; Fig. 13), wherein, when the period of time is longer than a predefined comparison period (a predefined comparison period is 0, no time lag [0151]), information is output that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time (“By placing the interval Td, the scan SC3 can be prevented from starting before the subject completes breath-holding. Further, both of the intervals Tc and Td may be placed in the delay time TD2′.” [0151]; Fig. 13).
Therefore, based on Nagasawa’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller to have the steps of determining a period of time between the time of the respiratory command and a reaction by the patient in which a respiratory signal following on from the respiratory command, wherein, when the period of time is longer than a predefined comparison period, information is output that the patient has followed the respiratory command too late and/or a start of a subsequent MR scan on the patient is delayed in accordance with the period of time, as taught by Nagasawa, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 9, Zeller modified by Nagasawa teaches the method of claim 8, wherein the period of time is a time of suspension (“the start time of the breath-holding state of the patient” [0029]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Zeller and Nagasawa as applied to claim 8, and further in view of Beck (US 20130211236), hereinafter, Beck.
Regarding claim 10, Zeller modified by Nagasawa teaches the method of claim 8.
Zeller modified by Nagasawa does not teach outputting information with respect of a switch to a different scan strategy or automatically performing the different scan strategy when it is established that the patient cannot follow the respiratory commands because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short.
However, in the MR imaging field of endeavor, Beck discloses MR data acquisition using physiological monitoring, which is analogous art. Beck teaches outputting information with respect of a switch to a different scan strategy or automatically performing the different scan strategy (“the imaging protocol optimization… the actually selected imaging protocol can be changed to a new imaging protocol” [0061]) when it is established that the patient cannot follow the respiratory commands because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short (“It has to be noted that in case the motion control detects that a patient cannot follow the breath hold instructions and also cannot hold the breath for a specified time not fulfilling a specified breath capability criteria, the imaging protocols can be set up to be automatically changed within the exam to a specified free breathing or a short breath hold protocol with a lower quality (lower resolution, 2D etc).” [0040] "Step 214 comprising the imaging protocol optimization … should be applied in case the motion control detects that a patient cannot follow the breath hold instructions or cannot follow the breath hold for a specified time not fulfilling a specified breath hold capability criteria. In this case, the actually selected imaging protocol can be changed to a new imaging protocol which requires a shorter data acquisition time for completing a respective magnetic resonance imaging scan.” [0061]).
Therefore, based on Beck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Nagasawa to employ the steps of outputting information with respect of a switch to a different scan strategy or automatically performing the different scan strategy when it is established that the patient cannot follow the respiratory commands because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short, as taught by Beck, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 11, Zeller modified by Nagasawa and Beck teaches the method of claim 10.
Zeller modified by Nagasawa does not teach that the different scan strategy is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing.
However, in the MR imaging field of endeavor, Beck discloses MR data acquisition using physiological monitoring, which is analogous art. Beck teaches that the different scan strategy is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing (“It has to be noted that in case the motion control detects that a patient cannot follow the breath hold instructions and also cannot hold the breath for a specified time not fulfilling a specified breath capability criteria, the imaging protocols can be set up to be automatically changed within the exam to a specified free breathing or a short breath hold protocol with a lower quality (lower resolution, 2D etc). The consequence is that the `recovery` period of the patient is extended.” [0040]).
Therefore, based on Beck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Nagasawa to employ the different scan strategy that is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing, or the breath-holding duration is too short, as taught by Beck, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Claims 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Zeller as applied to claims 1 and 5, and further in view of Hwang et al (KR 20180048502), hereinafter, Hwang.
Regarding claim 12, Zeller teaches the method of claim 5.
Zeller does not teach determining a gradient of the respiratory signal during the breath-holding duration; and outputting information or stopping a scan when an absolute value of the gradient falls below a predefined limit value.
However, in the MR imaging field of endeavor, Hwang discloses a medical imaging apparatus, and method for controlling thereof, which is analogous art. Hwang teaches determining a gradient of the respiratory signal during the breath-holding duration (“the breathing gradient” p. 8, 5th para.); and
outputting information or stopping a scan when an absolute value of the gradient (“the breathing gradient of the breathing curve” p. 14, 3rd complete para.) falls below a predefined limit value (below the “predetermined range” p. 14, 3rd complete para.; “the slope” p. 14, 4th and 5th complete para.) (“the controller 30 may obtain respiration information using the navigator image data restored based on the navigator MR data. Here, the respiration information includes various information indicating the respiration state of the object. For example, the respiration information may include at least one of the respiration curve of the subject, … the breathing gradient” p. 8, 5th para.; “the control unit 30 may determine the acquisition interval when the breathing gradient of the breathing curve is within a preset range. Referring to FIG. 5, in general, the breathing gradient of the breathing curve when exhaled corresponds to a certain range based on the time axis. Accordingly, the control unit 30 can determine the acquisition period for the region having the breathing gradient of the breathing curve corresponding to the predetermined range. As a specific example, the control unit 30 may determine an acquisition interval in which the breathing gradient is -N? Breathing gradient? + M (N, M? 0) based on the time axis.” p. 14, 3rd complete para.).
Therefore, based on Hwang’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller to have the steps of determining a gradient of the respiratory signal during the breath-holding duration; and outputting information or stopping a scan when an absolute value of the gradient falls below a predefined limit value, as taught by Hwang, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 16, Zeller modified by Hwang teaches the method of claim 1.
Zeller does not teach respiratory signals are acquired for multiple breath-holding MR scans on a patient and the respiratory behavior of the patient is determined from the multiple respiratory signals, wherein a mean value, a maximum value, a minimum value, or a combination thereof is determined for a breath-holding duration and/or a maximum value for a period of time between the time of the respiratory command and the time of suspension and/or a mean value for a gradient.
However, in the MR imaging field of endeavor, Hwang discloses a medical imaging apparatus, and method for controlling thereof, which is analogous art. Hwang teaches that
respiratory signals are acquired for multiple MR scans on a patient (multiple MR scans corresponding to the “respiration curve for each breathing cycle”; p. 14, 1st complete para.) and the respiratory behavior of the patient is determined from the multiple respiratory signals (“The MRI system can acquire the MR signal only in specific respiratory state while monitoring the respiratory state of the patient in real time while scanning. To this end, the MRI system can acquire breathing information (1900). For example, an MRI system can acquire respiration information of an object using a breathing detection navigator. At this time, the respiration information is various information that can grasp the respiration of the object, and it can include various information such as the breathing curve, the respiratory cycle, and the breathing gradient”; p. 15, the last para.),
wherein a mean value, a maximum value, a minimum value, or a combination thereof is determined for a breath-holding duration and/or a maximum value for a period of time between the time of the respiratory command and the time of suspension and/or a mean value for a gradient (“the breathing gradient at the same point in the mean breathing curve”; p. 14, 3rd para. from the end) (“when it is determined that the breathing gradient at a specific point in the breathing curve of the object is stronger than the breathing gradient at the same point in the mean breathing curve, the control unit 30 can determine the specific point as the acquisition start time have.” p. 14, 3rd para. from the end).
Therefore, based on Hwang’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller to have respiratory signals that are acquired for multiple breath-holding MR scans on a patient and the respiratory behavior of the patient is determined from the multiple respiratory signals, and a mean value, a maximum value, a minimum value, or a combination thereof that is determined for a breath-holding duration and/or a maximum value for a period of time between the time of the respiratory command and the time of suspension and/or a mean value for a gradient, as taught by Hwang, in order to improve MRI scanning of the patient by adjusting MR examination protocols based on obtained patient’s data. In the invention of Zeller and Hwang, MR scans are breath-holding MR scans.
Claims 14 -15 are rejected under 35 U.S.C. 103 as being unpatentable over Zeller as applied to claim 13, and further in view of Beck (US 20130211236), hereinafter, Beck.
Regarding claim 14, Zeller modified by Nagasawa teaches the method of claim 13.
Zeller does not teach outputting information with respect of a switch to a different scan strategy or automatically performing the different scan strategy when it is established that the patient cannot follow the respiratory commands because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short.
However, in the MR imaging field of endeavor, Beck discloses MR data acquisition using physiological monitoring, which is analogous art. Beck teaches outputting information with respect of a switch to a different scan strategy or automatically performing the different scan strategy (“the imaging protocol optimization… the actually selected imaging protocol can be changed to a new imaging protocol” [0061]) when it is established that the patient cannot follow the respiratory commands because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short (“It has to be noted that in case the motion control detects that a patient cannot follow the breath hold instructions and also cannot hold the breath for a specified time not fulfilling a specified breath capability criteria, the imaging protocols can be set up to be automatically changed within the exam to a specified free breathing or a short breath hold protocol with a lower quality (lower resolution, 2D etc).” [0040] "Step 214 comprising the imaging protocol optimization … should be applied in case the motion control detects that a patient cannot follow the breath hold instructions or cannot follow the breath hold for a specified time not fulfilling a specified breath hold capability criteria. In this case, the actually selected imaging protocol can be changed to a new imaging protocol which requires a shorter data acquisition time for completing a respective magnetic resonance imaging scan.” [0061]).
Therefore, based on Beck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller to employ the steps of outputting information with respect of a switch to a different scan strategy or automatically performing the different scan strategy when it is established that the patient cannot follow the respiratory commands because the period of time between the time of the respiratory command and the time of suspension is too long, or the breath-holding duration is too short, as taught by Beck, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Regarding claim 15, Zeller modified by Beck teaches the method of claim 14.
Zeller modified by Nagasawa does not teach that the different scan strategy is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing.
However, in the MR imaging field of endeavor, Beck discloses MR data acquisition using physiological monitoring, which is analogous art. Beck teaches that the different scan strategy is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing (“It has to be noted that in case the motion control detects that a patient cannot follow the breath hold instructions and also cannot hold the breath for a specified time not fulfilling a specified breath capability criteria, the imaging protocols can be set up to be automatically changed within the exam to a specified free breathing or a short breath hold protocol with a lower quality (lower resolution, 2D etc). The consequence is that the `recovery` period of the patient is extended.” [0040]).
Therefore, based on Beck’s teachings, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the invention of Zeller and Nagasawa to employ the different scan strategy that is a breathing-triggered MR scan or an unsynchronized MR scan in free breathing, or the breath-holding duration is too short, as taught by Beck, in order to improve MRI scans of the patient by adjusting MR examination protocols based on obtained patient’s data.
Conclusion
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/ALEXEI BYKHOVSKI/
Primary Examiner, Art Unit 3798