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 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 5, 8-9, and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of an abstract idea without significantly more.
In a test for patent subject matter eligibility, the claims pass Step 1 (see 2019 Revised Patent Subject Matter Eligibility), as they are related to a process, machine, manufacture, or composition of matter.
When assessed under Step2A, Prong I, Independent claim 5 is found to recite a judicial exception (i.e. abstract idea). In this instance, claim 5 recites the limitation “acquire a change in a display parameter related to image display” and “determine whether or not the display parameter after the change satisfies a predetermined condition”. The cited limitations, under their broadest reasonable interpretation, encompass a mental process (i.e. abstract idea) of acquiring information and determining which can be performed in the mind or by a human using a pen and a paper (e.g. observation, evaluation, judgment, opinion). In other words, a person could reasonably acquire a change in a display parameter related to image display via observation/evaluation (e.g. deciding to change a display parameter, seeing a display parameter has changed, etc) and determine whether or not the display parameter satisfies a predetermined condition via observation/evaluation. Examiner notes that with the exception of generic computer-implemented steps (e.g. processing circuitry recited in claim 5), there is nothing in the claims that preclude the limitation from being performed by a human, mentally or with pen and paper, thus the cited limitation(s) recites a judicial exception (MPEP 2106.04(a)) and the claim must be reviewed under Step 2A, Prong II to determine patent eligibility.
Step 2A, Prong II determines whether any claim recites an additional element that integrates the judicial exception into a practical application. Independent claims recites the following additional element(s):
In a first bloodstream imaging method during execution of the first bloodstream imaging method
Wherein the ultrasound diagnosis apparatus includes a bloodstream imaging mode of displaying a bloodstream imaging mode, wherein the bloodstream imaging mode includes a first bloodstream imaging method and a second bloodstream imaging method
The additional element(s) in the cited independent claim(s) are not found to integrate the judicial exception into a practical application. In this case, the cited limitations are merely directed to an intended field of use (i.e. bloodstream imaging) recited with such generality that the read on any bloodstream imaging (e.g. doppler). The cited limitations thus do no more than link the judicial exception to a particular technological environment or field of use. Therefore, under step 2A Prong II the Judicial exception is not integrated into a practical application by additional elements of independent claim 5 and the claims must be reviewed under Step 2B to determine patent eligibility.
Step 2B determines where a claim amounts to significantly more.
The additional elements listed above do not amount to significantly more than the judicial exception. Additionally there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. Therefore, under Step 2B in a test for patent subject matter eligibility, the judicial exeception of the independent claim(s) do not amount to significantly more and the independent claim(s) remain patent ineligible.
Dependent claims 8, 9, and 11 further limit the abstract idea of independent claim 5. When analyzed as a whole, these claims are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitations fail to establish that the claims are not directed towards an abstract idea and do not sufficiently integrate the subject matter into a practical application or recite elements which constitute significantly more than the abstract ideas identified. The dependent claims are directed toward additional elements which encompass abstract ideas
Under Step 2A, Prong II for dependent claims 8, 9, and 11, present additional elements which only further narrow the judicial exceptions (e.g. claim 8 which recites displaying information regarding whether or not to transition from the first bloodstream imaging method to the second bloodstream imaging method which is broadly recited and merely encompasses insignificant post-solution activity of displaying information/results, claim 9 which recites configured to transition from the first bloodstream imaging method to the second bloodstream imaging method when a transition command is issued which amounts to merely insignificant extra-solution activity of transitioning between modes without any specific linking to the judicial exception and claim 11 which further narrows the nature of the bloodstream imaging methods) and provide no additional element which are found to integrate the judicial exception into a practical application.
These dependent claims include no additional claims that are sufficient to amount to significantly more than the judicial exception. Additionally, there is no improvement in the functioning of the computer or technological field, and there is no transformation of subject matter into a different state. As discussed above with respect to integration of the abstract idea into a practical application, the additional claims do not provide any additional elements that would amount to significantly more than the judicial exception. Under Step 2B, these claims are not patent eligible.
Claims 6-7 and 10 are found to be patent eligible as they are directed to specific control of transitioning from one imaging method to another related to the change satisfying the predetermined condition, thus amounting to significantly more than the judicial exception.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph 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.
Claims 1-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “execute a blood stream imaging mode that displays a two-dimensional blood flow image based on a blood flow signal acquired by an ultrasound probe, the bloodstream imaging mode including (1) a first bloodstream imaging method, (2) a low-flow-rate blood stream imaging method different from the first blood stream imaging method and corresponding to imaging low-flow-rate blood stream, (3) a velocity bloodstream imaging method, and (4) a power Doppler imaging method”. There written description fails to provide sufficient support for a single blood stream imaging mode including each of the first bloodstream imaging method, the low-flow-rate bloodstream imaging method, the velocity bloodstream imaging method and the power Doppler imaging method. While there appears to be support for a blood stream imaging mode comprising (1) a first bloodstream imaging method and (2) a low-flow-rate bloodstream imaging method and a second bloods stream imaging mode comprising (3) a velocity bloodstream imaging method and (4) a power Doppler imaging method (see at least pg. 40-41 discloses on the other hand, in the second embodiment, a single bloodstream imaging mode includes a plurality of bloodstream imaging methods differing in the imaging method. Specifically, a specific bloodstream imaging mode, for example, includes a bloodstream imaging method for velocity display and a bloodstream imaging method for power display, and another specific bloodstream imaging mode includes a low-flow rate bloodstream imaging method and a high-resolution bloodstream imaging method), there does not appear to be any support at all regarding a blood flow imaging mode which comprises all 4 of the recited imaging methods. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim Rejections - 35 USC § 112(b)
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 1-4, 10, and 12-15 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.
Claim 1 recites the limitation “execute a blood stream imaging mode that displays a two-dimensional blood flow image based on a blood flow signal acquired by an ultrasound probe, the bloodstream imaging mode including (1) a first bloodstream imaging method, (2) a low-flow-rate blood stream imaging method different from the first blood stream imaging method and corresponding to imaging low-flow-rate blood stream, (3) a velocity bloodstream imaging method, and (4) a power Doppler imaging method”. The limitation is unclear as to whether the limitation is intending to set forth that the processing circuitry executes all of the bloodstream imaging methods listed (i.e. 1, 2, 3, and 4) in execution of the bloodstream imaging mode (e.g. simultaneously) or if the claim is intending to set forth that the blood stream imaging mode includes the recited methods and performs each one independently. For examination purposes, it has been interpreted that each method may be performed independently or not at all (for example when the bloodstream imaging mode includes other imaging methods), however, clarification is required.
The term “low-flow-rate bloodstream” in claim 1 is a relative term which renders the claim indefinite. The term “low-flow-rate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In this case, examiner notes that the specification describes a low-flow-rate in the same manner as claimed and while the specification describes and example of a low-flow rate range (e.g. less than 10 cm/s see pg. 31), such disclosure is merely directed towards an example of a low-flow-rate range and does not define the low-flow rate range as being limited to such an example. For at least these reasons, the metes and bounds of what is considered a “low-flow-rate bloodstream” is unclear. For examination purposes, it has been interpreted that any bloodstream lower than another has been considered to be low-flow-rate bloodstream, however, clarification is required.
Claim 1 recites the limitation “a velocity bloodstream imaging method” and “a power Doppler imaging method”. It is unclear if either of the velocity bloodstream imaging method or the power Doppler imaging method is the same as or corresponds with the first bloodstream imaging method or the second bloodstream imaging method. In other words, the claim does not clearly define the first bloodstream imaging method nor the second bloodstream imaging method (other than that it is corresponds to imaging a low-flow-rate bloodstream), thus in its broadest reasonable interpretation the first and/or second bloodstream imaging methods may be a velocity bloodstream imaging method or a power Doppler imaging method or may be some other bloodstream imaging method which has yet to be defined by the claim. For examination purposes, it has been interpreted to mean that they may be the same or different however clarification is required.
Claims 2 and 3 recite the limitation “the switch was made from the bloodstream imaging mode to the low-flow-rate bloodstream imaging mode”. There is insufficient antecedent basis for the limitation in the claim. Specifically it is noted that while claim 1 recites a transition from the first bloodstream imaging method to the low-flow-rate method, there is no recitation of a “switch” which is made from the bloodstream imaging mode to the low-flow-rate bloodstream imaging mode. Thus it is unclear if the claim is attempting to set forth a new switch between differing modes or if the claim is intending to refer back to the first transition recited of claim 1 from the first bloodstream imaging method to the low-flow-rate imaging method. For examination purposes, it has been interpreted to mean the latter, however, clarification is required.
Claims 3 and 4 recite the limitation ”the low-flow-rate bloodstream imaging mode”. There is insufficient antecedent basis for the limitation in the claim. It is therefore unclear if the limitation is attempting to refer back to the low-flow-rate bloodstream imaging method or if this is a different/distinct mode. For examination purposes, it ahs been intended to mean the low-flow-rate bloodstream imaging method and the bloodstream imaging mode recited in claim 4 is intended to mean the bloodstream imaging method, however, clarification is required.
Claim 3 recites the limitation ”the second value of the flow rate”. There is insufficient antecedent basis for the limitation in the claim. It is therefore unclear if the limitation is intending to refer to the changed flow rate range or if this is a different/distinct second value of the flow rate. For examination purposes, it has been interpreted to mean any second value of the flow rate, however, clarification is required.
Claim 10 recites the limitation “display information indicating that a transition has been made from the first bloodstream imaging method to the second bloodstream imagine method”. It is unclear if the information is the same as the information of claim 7 which indicates that a transition is made or if this is different information. If the limitation is intended to be the same information, its is unclear how claim 10 further narrows claim 7 as the information would appear to indicate the same information (transition is made = transition has been made). For examination purposes, it has been interpreted to mean any information, however, clarification is required.
Claim 12 recites the limitation “the second value of the display parameter”. There is insufficient antecedent basis for the limitation in the claim. It is unclear if the second value is intended to be the same as or correspond with the changed flow rate range or if this is a different “second value”. It is further unclear if the display parameter is the same as the flow rate range or if this is a different display parameter. For examination purposes, it has been interpreted to mean any second value of any display parameter and may be the same or different from the flow rate range/changed flow rate range, however, clarification is required.
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.
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.
(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.
(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.
(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.
Claims 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato (US 5078146 A), hereinafter Sato.
Regarding claim 5,
Sato discloses an ultrasound diagnosis apparatus (at least fig. 1 and corresponding disclosure in at least Col. 4 lines 1-3) comprising:
Processing circuitry (at least fig. 1 (12, 24, 26, 28, 36, 38, 40, 42, and 44) and corresponding disclosure in at least Col. 4-Col. 6) configured to:
Acquire a change in a display parameter related to image display in a first bloodstream imaging method during execution of the first bloodstream imaging method (Col. 5 line 59-Col. 6 line 5 which discloses the flow rate switch 36 is formed of a plurality of switches arranged in units of flow rate ranges and Col. 6 lines 20-23 which discloses when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected. Examiner thus notes that in any of the modes when a different switch is depressed the control circuitry thus acquires a change in a display parameter (i.e. flow rate range)), wherein the ultrasound diagnosis apparatus includes a bloodstream imaging mode of displaying a bloodstream signal acquired by an ultrasound probe, wherein the bloodstream imaging mode includes the first bloodstream imaging method and a second bloodstream imaging method differing from each other in at least one of a scan protocol or signal processing (Abstract which discloses a control circuit for controlling the scanning circuit in accordance with the flow rate designated by the manual operating member and changing the given number of radiations so as to change a sampling frequency for detecting a Doppler shift frequency, and to set optimal upper and lower limits of detectable Doppler shift frequencies. Col. 6 line 5 and Col. 6 lines 53-61 which discloses changing the sampling frequency (i.e. scan protocol) in accordance with an approximate range of flow rates at a target portion to be diagnosed); and
Determine whether or not the display parameter after the change satisfies a predetermined condition (Col. 6 lines 20-23 which discloses when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected. Thus requires a determination of whether or not the display parameter (i.e. the flow rate range) satisfies the predetermined condition of each of the different rate switches).
Regarding claim 6,
Sato further discloses wherein the processing circuitry is further configured to transition from the first bloodstream imaging method to the second bloodstream imaging method when the display parameter after the change satisfies the predetermined condition (Col. 6 lines 19-23 which discloses As shown in FIG. 4, when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected. Thus examiner notes that the processing circuitry is configured to transition from any of the currently used methods to another after the change satisfies the predetermined condition).
Regarding claim 7,
Sato further discloses wherein the processing circuitry is further configured to display information indicating that a transition is made from the first bloodstream imaging method to the second bloodstream imaging method (Col. 1 lines 15-19 which discloses The BDF apparatus is designed to output a color display of a blood flow image included in a tomographic image (B-mode image) in accordance with a blood flow direction and a blood flow rate and Col. 5 lines 54-59 which discloses an output form the DSC 26 is supplied to the display 46 through the color processing circuit. Examiner notes that the blood flow image or any other data displayed is considered information in its broadest reasonable interpretation and would indicate that a transition is/has been made from one bloodstream imaging mode to another by displaying data corresponding to the blood flow rates accordingly).
Regarding claim 8,
Sato further discloses wherein the processing circuitry is further configured to display information regarding whether or not to transition from the first bloodstream imaging method to the second bloodstream imaging method (Col. 1 lines 15-19 which discloses The BDF apparatus is designed to output a color display of a blood flow image included in a tomographic image (B-mode image) in accordance with a blood flow direction and a blood flow rate and Col. 5 lines 54-59 which discloses an output form the DSC 26 is supplied to the display 46 through the color processing circuit. Examiner notes that the blood flow image or any other data displayed is considered information in its broadest reasonable interpretation and is regarding whether or not to transition from one imaging method to another since a user could visualize the data and decide whether or not to transition accordingly).
Regarding claim 9,
Sato further discloses wherein the processing circuitry is further configured to transition from the first bloodstream imaging method to the second bloodstream imaging method when a transition command is issued (Col. 6 lines 20-23 which discloses when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected)
Regarding claim 10,
Sato further discloses wherein the processing circuitry is further configured to display information indicating that a transition has been made from the first bloodstream imaging method to the second bloodstream imaging method (Col. 1 lines 15-19 which discloses The BDF apparatus is designed to output a color display of a blood flow image included in a tomographic image (B-mode image) in accordance with a blood flow direction and a blood flow rate and Col. 5 lines 54-59 which discloses an output form the DSC 26 is supplied to the display 46 through the color processing circuit. Examiner notes that the blood flow image or any other data displayed is considered information in its broadest reasonable interpretation and would indicate that a transition is/has been made from one bloodstream imaging mode to another by displaying data corresponding to the blood flow rates accordingly)..
Regarding claim 11,
Sato further discloses wherein the first bloodstream imaging method displays flow rate information of a bloodstream, and the second bloodstream imaging method displays flow rate information of a bloodstream (Col. 5 lines 60-63 which discloses the flow rate switch 36 serves to input an approximate flow rate at a portion to be diagnosed of an object to be examined as a parameter for changing a raster control mode and Col. 5 lines 46-53 which discloses in a color processing circuit 42, similar to a conventional apparatus, a color Doppler image is displayed in such a manner that a direction toward the probe 10 and a direction from the probe 10 are respectively represented by red and blue, a mean velocity is represented by the saturation of a color, and a rate variance is represented by hue (mixing of green). Examiner notes that in each of the imaging methods (high, medium, or low rates) that flow rate information is thus displayed).
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 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.
Claims 1, 4, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over by Sato (US 5078146 A), hereinafter Sato in view of Iinuma (US 551434 A), hereinafter Iinuma.
Regarding claim 1,
Sato teaches an ultrasound diagnosis apparatus (at least fig. 1 and corresponding disclosure in at least Col. 4 lines 1-3) comprising:
Processing circuitry (at least fig. 1 (12, 24, 26, 28, 36, 38, 40, 42, and 44) and corresponding disclosure in at least Col. 4-Col. 6) configured to:
execute a bloodstream imaging mode (see at least fig. 6 and corresponding disclosure in at least [0056]) that displays a two-dimensional blood flow image based on a blood flow signal acquired by an ultrasound probe (Col. 1 lines 15-19 which discloses the BDF apparatus is designed to output a color display of a blood flow image included in a tomographic image (B-mode image) in accordance with a blood flow direction and a blood flow rate), the bloodstream imaging mode including (1) a first bloodstream imaging method, (2) a low-flow-rate bloodstream imaging method different form the first bloodstream imaging method (Col. 5 line 60 -Col. 6 line 5 disclosing a flow rate switch to input an approximate flow rate at a portion to be diagnosed of an object to be examined as a parameter for changing a raster control mode (considered an imaging method)), and (3) a velocity blood-stream imaging method (Col. 5 lines 46-53 which disclose in a color processing circuit 42, similar to a conventional apparatus, a color Doppler image is displayed in such a manner that a direction toward the probe 10 and a direction from the probe 10 are respectively represented by red and blue, a mean velocity is represented by the saturation of a color, and a rate variance is represented by hue (mixing of green. Examiner thus notes that the color Doppler processing is considered a velocity blood-stream imaging method);
Acquire a flow rate range changed by a user during an execution of the first bloodstream imaging method (Col. 6 lines 19-23 which discloses As shown in FIG. 4, when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected);
Compare the changed flow rate range with a threshold value and determine whether or not the changed flow rate range is less than the threshold value (Col. 5 line 60- Col. 6 line 5 which discloses The flow rate switch 36 is formed of a plurality of switches arranged in units of flow rate ranges, three switches in this case, namely a high rate switch 36a, a medium rate switch 36b, and a low rate switch 36c. In this case, the medium rate switch 36b is for the abdomen and corresponds to a flow rate range of 10 to 30 cm/s. Flow rates higher than this flow rate range correspond to the high rate switch 36a (for the heart). Flow rates lower than this flow rate range correspond to the low rate switch 36c (for the limb) and Col. 6 lines 19-23 which discloses As shown in FIG. 4, when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected. Examiner notes that such depression of switches and corresponding control thereafter requires comparison of the flow rate range to a threshold in order to operate accordingly. In other words, the switches are associated with specific flow rate ranges and thus when depressed are compared with thresholds such as the ranges associated with the other ranges and determines whether or not the changed flow rate range is less than the threshold value (e.g. whether it is less than 10 cm/s for the low rate switch less than 30cm/s for the medium rate switch);
Cause a first transition from the first bloodstream imaging method to the low-flow rate bloodstream imaging method in the case where the changed blood flow rate range is less than the threshold value (Col. 6 lines 20-24 which discloses as shown in FIG. 4, when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected); and
Cause a second transition from the low-flow-rate bloodstream imaging method to the first bloodstream imaging method in the case where the flow rate range is changed to the threshold value or more in the low-flow-rate bloodstream imaging method after the first transition (Col. 6 lines 20-24 which discloses as shown in FIG. 4, when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected. Examiner notes that after a first transition when one of the medium rate or low rate switches is depressed and a user then selects respectively the high rate or medium rate switch that the system would therefore cause a transition from the low-flow rate bloodstream imaging method (i.e. the medium or low rate) to the first bloodstream imaging method (i.e. the high or medium rate, respectively) see also claim 11 disclosing at least two switches for respectively designating low and high flow rate ranges);
Sato fails to explicitly teach wherein the bloodstream imaging mode includes a power Doppler imaging method.
Nonetheless, Iinuma in a similar field of endeavor, teaches wherein a bloodstream imaging mode includes a flow-rate imaging method, a velocity imaging method, and a power Doppler imaging method (Col. 16 lines 18-35 which discloses although the time compensation technique has been described in terms of flow rate measurement, it may also be used for displaying a tomography image and a velocity image, power Doppler image and a tissue Doppler image in real time)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Sato to include a power Doppler imaging method as taught by Iinuma in order to provide additional diagnostic data which would enhance the diagnostic capabilities of the system of Sato. Examiner notes that including a power Doppler imaging method would provide enhanced sensitivity of slow moving blood flow, thus allowing for imaging which would provide additional diagnostic data for assisting in diagnosing inflammatory conditions for example.
Regarding claim 4,
Sato, as modified, teaches the elements of claim 1 as previously stated. Sato further teaches wherien an imaging method differs between the bloodstream imaging mode and the low-flow-rate imaging mode, and the imaging method is defined by a scan protocol and a signal processing method (Col. 6 lines 24-52 which discloses the different imaging methods for each of the bloodstream imaging methods. Examiner notes that the imaging method is defined by a scan protocol (i.e. sampling frequency) and corresponding signal processing (i.e. by DSC26/color processing circuit 42)).
Regarding claim 12,
Sato, as modified, teaches the elements of claim 1 as previously stated. Sato further teaches wherein the processing circuitry is further configured to compare the second value of the display parameter with the threshold (Col. 6 lines 20-23 which discloses when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected, requiring a comparison of the flow rate range (i.e. second value of the display parameter) with the threshold)
Regarding claim 14,
Sato, as modified, teaches the elements of claim 1 as previously stated. Sato further teaches wherein the processing circuitry is further configured to:
Acquire another changed flow rate range after the first transition during execution of the low-flow-rate bloodstream imaging method(Col. 6 lines 20-23 which discloses when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected. Examiner notes that the processing circuitry is configured to acquire any such changed flow rate range through depression of the switch at any point in time including after the first transition); and
cause the second transition from the low-flow-rate bloodstream imaging method to the first bloodstream imaging method when determining that the another changed flow rate range is greater than the threshold value (Col. 6 lines 20-23 which discloses when the high rate switch 36a is depressed, mode 1 is selected. When the medium rate switch 36b is depressed, mode 2 is selected. When the low rate switch 36c is depressed, mode 3 is selected).
Claims 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sato and Iinuma as applied to claim 1 above, and further in view of Elgena et al. (US 20200129156 A1), hereinafter Elgena.
Regarding claim 2,
Sato, as modified, teaches the elements of claim 1 as previously stated. Sato, as modified, fails to explicitly teach wherein the processing circuitry is configured to display, as text on a display screen, information indicating that the switch wase made form the bloodstream imaging mode to the low-flow-rate bloodstream imaging mode.
Elgena, in a similar field of endeavor involving blood flow imaging, teaches wherein the processing circuitry is further configured to display, as text on a display screen, information indicating that the switch was made from the bloodstream imaging mode to the low-flow-rate bloodstream imaging mode (See at least figs. 5 and 6 and [0054] which discloses the range control option may include text indicating the current range and the processing circuitry may change text displayed by the range control option (e.g. from “low” to “high” or from “high” to “low”). Examiner notes such displaying of text (e.g. low or high) indicates that the switch was made).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Sato, as currently modified, to include displaying as text on a display screen information as taught by Elgena in order to allow a user to readily recognize which imaging method is being used. Such a modification would therefor enhance a user’s understanding of the flow-rate range which is currently being imaged by looking at the display screen accordingly.
Regarding claim 15,
Sato, as modified, teaches the elements of claim 2 as previously stated. Elgena, as applied to claim 2 above, further teaches wherein the processing circuitry is further configured to display the text at a position not overlapping with a region of interest (ROI) on an ultrasonic image (See at least figs. 1-6 which depict the text not overlapping with a region of interest (ROI) (i.e. 102) on an ultrasonic image)
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Sato and Iinuma as applied to claim 1 above, and further in view of Cadieu et al. (US 20210052255 A1), hereinafter Cadieu.
Regarding claim 3,
Sato, as modified, teaches the elements of claim 1 as previously stated.
Sato, as modified, fails to explicitly teach wherein the processing circuitry is further configured to display, as text on a display screen, information that recommends the low-flow-rate bloodstream imaging mode when the second value of the flow rate indicates that the switch to the low-flow-rate bloodstream imaging mode from the bloodstream imaging mode should be performed.
Cadieu, in a similar field of endeavor involving ultrasound imaging methods, teaches processing circuitry configured to display, as text on a screen, information that recommends a second imaging mode when a display parameter after a change is more suitable for the second imaging mode than for the first imaging mode ([0014] which discloses the program code is enabled to detect in the acquired imagery, a feature of the target organ mode mapped to a different operating mode (i.e. more suitable for a second imaging mode) and to respond to the detection by displaying a recommendation in a display of the computer to change operating modes of the ultrasound imaging probe and [0012] which discloses a textual reference to the recommended change of operating mode)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Sato, as currently modified, to include displaying information as taught by Cadieu in order to allow the user to visualize when a transition between imaging modes is occurring. Such a modification would provide ultrasound guidance that is not dependent on the skill of the operator, therefore, specialized knowledge and expertise on the part of the ultrasound operator to acquire high quality ultrasound images is not required and iterative trial and error can be avoided (see Cadieu [0006]-[0010])
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Sato and Iinuma as applied to claim 1 above, and further in view of Shibata et al. (US 20170224307 A1), hereinafter Shibata.
Regarding claim 13,
Sato, as modified, teaches the elements of claim 1 as previously stated. Sato, as modified, fails to explicitly teach wherein the processing circuitry is further configured to: receive a change in the threshold; and compare the changed flow rate range with the changed threshold.
Shibata, in a similar field of endeavor involving ultrasound flow imaging, teaches wherein processing circuitry is further configured to: receive a change in a threshold ([0064] In this case, with respect to the receiving function 171, the direction of turn of the tab is associated with an increase/decrease of the upper limit value and the amount of turn of the tab is associated with the amount of a change of the upper limit value. When the operator turns the tab in the direction to increase the upper limit value, the receiving function 171 receives the turn as an instruction for increasing the upper limit value corresponding to the amount of turn of the tab)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Sato, as currently modified, to include receiving a change in threshold as taught by Shibata in order to allow for enhanced variability of the system. Such a modification would allow for additional/different desired flow rate ranges as desired by the user such that imaging specific flow rates may be imaged as desired for specific diagnostic purposes.
Examiner notes that in the modified system, the processing circuitry would thus compare the changed flow rate range with the changed threshold in order to perform the corresponding imaging method as desired.
Conclusion
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/BROOKE LYN KLEIN/Examiner, Art Unit 3793