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) are an imaging apparatus, a non-contact detection apparatus, a display apparatus, a signal processing module, a recording module, a processing module, a prediction module, an indication information generation module, in claims 1, 3, 5-8, 11, and 13-16 the corresponding structure can be found in ¶¶ [0098] - [0123] and ¶¶ [0069] - [0073] of the specifications.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 and 15-16 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.
Claims 7 and 15 have antecedent basis issue for "the candidate extreme value", should depend from 6 and 14 not 5 and 13.
Claim 8 has antecedent basis issue for "the prediction module" should depend from 6 not 5
Claim 8 has antecedent basis issue for "the second time period" should depend from 6 not 5
Claim 16 has antecedent basis issue for "the second time period" should depend from 14 not 13.
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 (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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, 9-10, and 13 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Menser (US 20240065663).
Regarding claim 1:
Menser discloses: A medical imaging system (FIG. 1, ¶¶ [0001] and [0092]), comprising:
an imaging apparatus, which acquires a medical image of a subject under examination (¶¶ [0093] – [0094] disclose x-ray imaging system 100 acquires an x-ray projection image of a patient);
a non-contact detection apparatus, which performs non-contact detection on the subject under examination on the basis of a wireless signal, so as to acquire data related to vital signs of the subject under examination (¶¶ [0008], [0097], [0105] - [0107] disclose sensor 120 acquiring a sequence of depth images of the patient to extract the patient’s breathing signal and a breathing status determination device 10 to determine breathing status. ¶¶ [0058], [0101] disclose that the sensor 120 may include a three-dimensional (3D) contactless motion scanner using e.g. light detection and ranging (LIDAR), radio detection and ranging (RADAR), or camera based sensor).
a signal processing module, which processes the data to generate information reflecting the vital signs (¶¶ [0007], [0053], [0108], [0125] – [0126] disclose processing unit 14 that processes the received sequence of depth to output a breathing signal, also referred to as respiratory signal); and
a display apparatus, which displays a graphical user interface used to control the imaging apparatus, and the information reflecting the vital signs (¶¶ [0014], [0095], and [0110] disclose console 116 and screen 118 are used by a medical lab technician who can control via the console 116 an image acquisition run by releasing individual x-ray exposures for example by actuating a joy stick or pedal or other suitable input coupled to the console 116, and the respiratory signal may be displayed to the operator at the console and/or tube head to give feedback on the actual breathing state).
Regarding claim 2:
Menser further discloses: wherein the data related to the vital signs of the subject under examination comprises at least one of the following pieces of data: data related to breathing of the subject under examination; data related to heartbeats of the subject under examination; and data related to the pulse of the subject under examination (¶¶ [0007] – [0009, [0107], [0108]disclose data related to breathing).
Regarding claim 5:
Menser further discloses: a processing module (¶¶ [0106] and [0108] states that the breathing status determination device 10 comprises an input unit 12, a processing unit 14, and an output unit 16 and that the sequence of depth images is fed into the breathing status determination device 10, and that processing unit 14 processes the received sequence of depth images to output a breathing signal or respiratory signal);
which calculates, according to the information reflecting the vital signs, a candidate timing for the imaging apparatus to acquire the medical image (¶¶ [0025] – [0027] teaches determining an x-ray release/acquisition time point based on the breathing signal and automated triggering of image acquisition at the determined time point, [0066] – [0068] teaches manual or automated triggering of image acquisition at the determined time point and that the system may delay actual image acquisition within a predefined time window to find the optimal point in time with respect to the breathing state and respiratory motion, [0153] – [0154] teaches that an RNN extracts temporal features from breathing signals and the imaging system is controlled for image acquisition at the determined time point)
wherein the display apparatus displays the candidate timing (¶ [0065] teaches displaying the signal in real time at the operator console so that the operator can select the optimal release time. ¶ [0110] teaches that the respiratory signal may be displayed on screen 118 so the operator can check whether the patient is responding to breathing commands and release x-ray exposure when appropriate. ).
Regarding claims 9-10, and 13: the claims limitations are similar to those of claims 1-2, and 5; therefore, rejected in the same manner as applied above.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Menser (US 20240065663) in view of Nakamura (US 20080089463)
Regarding claim 3:
Menser does not specifically teach: a recording module, which records information on a time point at which the imaging apparatus acquires the medical image, wherein the display apparatus displays the information on the time point at which the imaging apparatus acquires the medical image.
However, in the same field of endeavor, Nakamura teaches: a recording module (¶ [0106], [0108], and ¶ [0127] disclose an X-ray computed tomographic apparatus including X-ray tube 2101, a preprocessing device 2106, and a rotation driving unit 2107, and a high voltage generator 2109, and a scan controller 2110 controls the operations of the rotation driving unit 2107, high voltage generator 2109, and the like to perform data acquisition (scanning). The scan controller 2110 transmits a control signal information to the user navigation system and the examination information window displays that control signal information);
which records information on a time point at which the imaging apparatus acquires the medical image (¶ [0108] and ¶ [0127] disclose that the scan controller controls the scanning /data acquisition operation. The information of a control signal includes a data code as information which specifies a display item and an audio item, the time of generation of the control signal, the type of control signal, and information indicating the results of execution of display and audio item outputs. Therefore, the recorded time of generation of the control signal corresponds to timing information associated with the imaging apparatus acquiring the medical image);
wherein the display apparatus displays the information on the time point at which the imaging apparatus acquires the medical image (¶ [0127] discloses that FIG. 46 shows an examination information window displayed on the screen of a display device 2116 of the X-ray CT apparatus or the operation device 2115 and that information of a control signal includes a data code as information which specifies the time of generation of the control signa and information indicating the results of execution of display and audio item outputs).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Menser incorporate the teachings of Nakamura by including recoding/displaying of scan control timing information in order to allow the operator to verify when image acquisition occurred relative to the displayed breathing signal. Both references concern medical imaging systems where timing of image acquisition is important to image quality, where Menser displays breathing information so the operator can release x-ray exposure at an appropriate breathing state, and Nakamura displays the scan controlled timing so the operator can verify the timing, type and result of scant related control events.
Regarding claim 11: the claim limitations are similar to those of claim 3; therefore, rejected in the same manner as applied above.
Claim(s) 6, 8, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Menser (US 20240065663) in view of He (US 20210378603).
Menser does not specifically teach: a prediction module, which predicts, on the basis of information reflecting the vital signs within a first time period, information reflecting the vital signs within a second time period after the first time period; and an extreme value detection module, which detects extreme values in the information reflecting the vital signs within the second time period, and sets the extreme value closest in time to that within the first time period as a candidate extreme value.
However, in a related field, He teaches: a prediction module (¶ [0153] teaches a respiration signal prediction module 136 for predicting in real time, according to the most recent respiration signal of a preset length of the acquisition subject, a respiration signal at the next sampling point of the acquisition subject);
which predicts, on the basis of information reflecting the vital signs within a first time period, information reflecting the vital signs within a second time period after the first time period (¶ [0090] discloses predicting in real time, according to the most recent respiration signal of a preset length of the acquisition subject, a respiration signal at the next sampling point of the acquisition subject. ¶ [0093] further explains that a previous respiration signal is first used to predict subsequent respiration signal. ¶¶ [0120] – [0123] further teaches training a respiration signal predictive model where the neural network output is a respiration signal delayed by ne sampling point, and where the model learns an association between previous respiration signals and a subsequent respiration signal. ¶ [0125] also explains that points s1 and s2 are predicted using original respiration signal periods t1 and t2, and that the predicted signal is output in a later interval.); and
an extreme value detection module, which detects extreme values in the information reflecting the vital signs within the second time period, and sets the extreme value closest in time to that within the first time period as a candidate extreme value (He ¶ [0147] teaches an expiration peak value prediction module 132 for predicting in real time an expiration amplitude peak value of an expiration signal in the current respiration period. ¶ [0148] teaches a triggering detection module 133 that calculates a trigger point threshold from the predicted expiration amplitude peak value and triggering MR data acquisition when the current expiration signal satisfies the threshold condition. Also see He ¶¶ [0090] – [0093] and [0138] – [0140]. He uses the current/upcoming predicted respiration period peak following the most resent measured respiration signal as the basis for triggering acquisition, it would have been obvious to select the nearest upcoming predicted peak after the first time period the claim candidate extreme value).
wherein a time point corresponding to the candidate extreme value is at least a portion of the candidate timing (Menser in ¶¶ [0025] – [0027] teach determining a time point for releasing x-ray exposure based on the breathing signal and automatically gating or triggering image acquisition at that determined time point. Menser ¶ [0153] – [0154] further teach extracting the time point for releasing x-ray exposure from the breathing signal and automatically triggering image acquisition at the determined time point. He in ¶¶ [0147] – [0148] teach predicting the expiration amplitude peak value and using a trigger threshold derived from that peak value to trigger MR data acquisition. He ¶ [0140] similarly teaches multiplying the predicted expiration amplitude peak value by preset coefficient to obtain current trigger point threshold, calculating the difference between the current respiration signal and the threshold, and triggering MR data acquisition when the difference is less than a preset threshold).
Therefore, it would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified Menser to incorporate the teachings of He by including predicting respiratory signal evolution and peak value improves trigger accuracy and reduces missed, premature, or late triggering to improve accuracy in determining the candidate x-ray acquisition timing and reduce motion artifacts.
Regarding claim 8:
He further teaches: , wherein the prediction module predicts the information reflecting the vital signs within the second time period on the basis of a long short term memory (LSTM) neural network (¶¶ [0120] – [0123], and [0143] teach a respiration signal predictive model in which prior respiration signals are input and subsequent respiration signal is output., and that the NN used may be TCN, RNNN, or LSTM).
Regarding claims 14 and 16: the claims limitations are similar to those of claim 6 and 8; therefore, rejected in the same manner as applied above.
No prior art has been applied to claims 7 and 15.
Allowable Subject Matter
Claims 4 and 12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mostafavi (US 20050201510) teaches: estimating regular cycles of physiological activity or movements, and physiological gating of radiation treatment based upon the phase of the physiological activity.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WASSIM MAHROUKA whose telephone number is (571)272-2945. The examiner can normally be reached Monday-Thursday 8:00-5:00 EST.
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/WASSIM MAHROUKA/ Primary Examiner, Art Unit 2665
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