DETAILED ACTION
The present office action represents a final action on the merits.
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 .
Priority
This application claims the priority date of foreign application JP2022-061029, of March 31, 2022 and is a CON of PCT/JP2023/008201 of March 6, 2023.
Status of Claims
Claims 1, 7, and 13 are amended, claims 5, 11, and 17-18 are cancelled, and claims 1-4, 6-10. 12-16, and 19-20 are pending.
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 1-4, 6-10, 12-16, and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-4 and 6 are drawn to non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process, which is within the four statutory categories (i.e., machine). Claims 7-10 and 12 are drawn to an information processing method, which is within the four statutory categories (i.e., process). Claims 13-16 and 19-20 are drawn to an information processing device, which is within the four statutory categories (i.e., machine).
Claims 1-4 and 6 recite a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process comprising:
acquiring patient information regarding a patient to be treated and surgical procedure information regarding a surgical procedure scheduled for the patient;
acquiring a treatment plan on the basis of the patient information, wherein the treatment plan includes a procedure for performing a series of treatments and an amount of the contrast agent to be administered in the procedure and the surgical procedure information;
outputting a contrast agent use plan for the patient on the basis of the treatment plan, wherein the contrast agent use plan includes a form of a graph that indicates a relationship between a progress status of a treatment plan and a scheduled amount of a contrast agent to be used;
acquiring the progress status of the treatment plan;
acquiring an administered amount of the contrast agent already administered to the patient;
changing the scheduled amount of the contrast agent to be used to the administered amount of the contrast agent for a region of the graph where the treatment plan has already been executed; and
outputting the changed graph.
Claims 7-12 recite an information processing method executed by a computer, the method comprising:
acquiring patient information regarding a patient to be treated and surgical procedure information regarding a surgical procedure scheduled for the patient;
acquiring a treatment plan on the basis of the patient information and the surgical procedure information, wherein the treatment plan includes a procedure for performing a series of treatments and an amount of the contrast agent to be administered in the procedure;
outputting a contrast agent use plan for the patient on the basis of the treatment plan, wherein the contrast agent use plan includes a form of a graph that indicates a relationship between a progress status of a treatment plan and a scheduled amount of a contrast agent to be used;
acquiring the progress status of the treatment plan;
acquiring an administered amount of the contrast agent already administered to the patient;
changing the scheduled amount of the contrast agent to be used to the administered amount of the contrast agent for a region of the graph where the treatment plan has already been executed; and
outputting the changed graph.
Claims 13-20 recite an information processing device comprising a control unit, wherein the control unit is configured to:
acquire patient information regarding a patient to be treated and surgical procedure information regarding a surgical procedure scheduled for the patient;
acquire a treatment plan on the basis of the patient information and the surgical procedure information, wherein the treatment plan includes a procedure for performing a series of treatments and an amount of the contrast agent to be administered in the procedure;
output a contrast agent use plan for the patient on the basis of the treatment plan, wherein the contrast agent use plan includes a form of a graph that indicates a relationship between a progress status of a treatment plan and a scheduled amount of a contrast agent to be used;
acquire the progress status of the treatment plan;
acquire an administered amount of the contrast agent already administered to the patient;
change the scheduled amount of the contrast agent to be used to the administered amount of the contrast agent for a region of the graph where the treatment plan has already been executed; and
output the changed graph.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity, but for the recitation of generic computer components (e.g., a computer, control unit, processing device). The underlined limitations are not part of the identified abstract idea (the method of organizing human activity) and are deemed “additional elements,” and will be discussed in further detail below.
Dependent claims 2-4, 6, 8-10, 12, 14-16, and 19-20 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. These limitations only serve to further limit the abstract idea (or contain the same additional elements found in the independent claim), and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 7, and 13.
The dependent claims recite additional limitations, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 7, and 13.
The additional elements from claim 1 include:
a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process comprising (apply it, MPEP 2106.05(f)).
The additional elements from claim 7 include:
a computer (apply it, MPEP 2106.05(f)).
The additional elements from claim 13 include:
an information processing device comprising a control unit (apply it, MPEP 2106.05(f)).
These additional elements, in the independent claims are not integrated into a practical application because the additional elements (i.e., the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of “a non-transitory computer-readable medium”, “an information processing device comprising a control unit”, “a computer”, which amounts to merely invoking a computer as a tool to perform the abstract idea e.g., see Specification Paragraphs [0050]-[0052], [0143]-[0145], and [0149]-[0161], (See MPEP 2106.05(f)).
Furthermore, the claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e., the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification discloses that the additional elements are well-understood, routine, and conventional in nature (i.e., the Specification Paragraphs [0050]-[0052], [0143]-[0145], and [0149]-[0161] disclose that the additional elements (i.e., a non-transitory computer-readable medium, an information processing device comprising a control unit, a computer) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions that are well understood routine, and conventional activities previously known to the pertinent industry (i.e., healthcare, a contrast agent use plan on the basis of a treatment plan);
Relevant court decisions: The following example of court decision demonstrating well understood, routine and conventional activities, e.g., see MPEP 2106.05(d)(II): Receiving medication use data, e.g., see Intellectual Ventures v. Symantec – similarly, the current invention receives data for contrast agent use.
Dependent claims 2-4, 6, 8-10, 12, 14-16, and 19-20 include other limitations, but none of these functions are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly represent no more than receiving data over a system (e.g., receive modification of treatment plan, claims 3, 9, and 15.).
Thus, taken alone, the additional elements do not amount to “significantly more” than the above identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves any other technology, and their collective functions merely provide conventional computer implementation.
The application, is an attempt to organize human activity. The inventive concept is acquiring patient information and outputting a contrast agent use plan for the patient on the basis of the treatment plan, which is not patentable. Therefore, whether taken individually or as an ordered combination, claims 1-4, 6-10. 12-16, and 19-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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)(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 7-10, 12-16, and 19 are rejected under 35 U.S.C. 102(1) as being anticipated by Uber (U.S. Pub. No. 2001/0056233 A1).
Claim 7, discloses substantially the same limitations as Claim 1 excluding a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process and including the additional limitations Uber discloses an information processing method executed by a computer, the method comprising (Paragraph [0014] discusses methods for medical contract imaging.).
Claims 8 and 14, disclose substantially the same limitations as Claim 2 excluding a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process.
Claims 9 and 15, disclose substantially the same limitations as Claim 3 excluding a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process.
Claims 10 and 16, disclose substantially the same limitations as Claim 4 excluding a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process.
Regarding claims 12 and 19, disclose substantially the same limitations as Claim 6 excluding a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process.
Claim 13, discloses substantially the same limitations as Claim 1 excluding a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process and including the additional limitations Uber discloses an information processing device comprising a control unit, wherein the control unit is configured to (Paragraphs [0016] and [0051] discuss various types of sensors are disclosed for use with the control system, in particular, various electromagnetic sensors or video monitoring devices provide feedback for the system or operator to use.) (Examiner is interpreting the control system as the control unit because the control system performs the functions of the control unit outlined in the Specification.).
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 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Uber in view of Uber II (U.S. Pub. No. 2022/0133982 A1).
Regarding claim 1, Uber discloses acquiring patient information regarding a patient to be treated and surgical procedure information regarding a surgical procedure scheduled for the patient (Paragraphs [0010], [0012], [0014], and FIG. 4 discuss medical contrast imaging and provide patient specific dosing of contrast media in a variety of medical imaging procedures, as opposed to fixed protocols where the protocol variables are determined by the system and are dependent upon patient specific information supplied by the operator, and/or information measured by the contrast delivery system either prior to, or during the injection procedure.);
acquiring a treatment plan on the basis of the patient information and the surgical procedure information, wherein the treatment plan includes a procedure for performing a series of treatments and an amount of the contrast agent to be administered in the procedure (Paragraphs [0056] and FIG. 4 discuss for the medical imaging procedure, the Electronic Control System computes the appropriate concentration of contrast media and the injection parameters such as flow rates, volume, and time delay etc. for the medical contrast imaging. The resultant concentration and injection parameters are then displayed. The operator then reviews the parameters and decides whether to manually modify the procedure.);
outputting a contrast agent use plan for the patient on the basis of the treatment plan, wherein the contrast agent use plan includes a form of a graph that indicates a relationship between a progress status of a treatment plan and a scheduled amount of a contrast agent to be used (Paragraphs [0014], [0056], and FIG. 4 discuss for the medical imaging procedure, the Electronic Control System computes the appropriate concentration of contrast media and the injection parameters such as flow rates, volume, and time delay etc. for the medical contrast imaging and provide dosing of contrast media in a variety of medical imaging procedures. The resultant concentration and injection parameters are then displayed. The operator then reviews the parameters and decides whether to manually modify the procedure;
acquiring the progress status of the treatment plan (Paragraph [0010] discusses provide an improved contrast media delivery system which is capable of automatically varying the injection rate and concentration of contrast media given to a patient during an imaging procedure, based on information received either before or during the injection procedure.);
acquiring an administered amount of the contrast agent already administered to the patient (Paragraphs [0016] and [0018] discuss providing tactile feedback to a doctor or operator in addition to visual or other sensed feedback on the amount of contrast media in a patient.);
changing the scheduled amount of the contrast agent to be used to the administered amount of the contrast agent for a region of the graph where the treatment plan has already been executed (Paragraphs [0011], [0072], and FIG. 7 discuss obtains and utilizes feedback information during the imaging procedure to automatically adjust the flow rate, volume and/or concentration of the contrast media into the patient if needed.); and
outputting the changed graph (Paragraphs [0038], [0057]-[0059], and [0096] discuss computed concentration of contrast media and injection parameters are then displayed; feedback could be displayed on the video monitor along with the patient image and simultaneous display is the use of numbers on the monitor which indicate flow rate or a bar graph or a syringe outline which empties as the fluid is injected, when results of test injection are satisfactory, the final injection parameters are selected, which may involve operator fine tuning the procedure and making adjustments and updating parameters to customize injection procedure, and feedback displayed on video monitor.)
Uber does not explicitly disclose:
a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process comprising.
Uber II teaches:
a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process comprising (Paragraph [0033] discusses a processor and non-transitory machine-readable storage medium, wherein the non-transitory machine-readable storage medium comprises programming instructions that, when executed by the processor, enable the fluid administration device to.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Uber to include, a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process comprising, as taught by Uber II, in order to provide patient-specific information that can then be used to better model the diagnostic injection and/or accompanying medical imaging procedure, including information regarding the patient's physical response to receiving the injection of a medical fluid as well as the manner and rate at which the medical fluid propagates through the system fluid path and/or through the patient. (Uber II Paragraph [0059].).
Regarding claim 2, Uber discloses wherein the process further comprises:
acquiring a preoperative acceptable amount regarding a contrast agent to be administered to the patient, the preoperative acceptable amount being calculated on the basis of the patient information (Paragraphs [0014], [0042], and FIG. 4 discuss provide patient specific dosing of contrast media dependent on patient specific information supplied by the operator and information measured by the contrast delivery system prior to the injection procedure.); and
outputting the preoperative acceptable amount along with the contrast agent use plan (Paragraph [0042] discusses ECS is capable of sending and receiving information so that, for example, the operator only needs to program the CT scanner with the number of slices and section of the body being imaged and this would be transmitted to the contrast delivery system to be used in determining flow rates and delays, etc. and information relating to image quality or sensed concentration of contrast media is received to allow for automatic adjustment of the system.).
Regarding claim 3, Uber discloses wherein the process further comprises:
receiving modification of the treatment plan (Paragraph [0042] discusses ECS is capable of sending and receiving information so that, for example, the operator only needs to program the CT scanner with the number of slices and section of the body being imaged. This would be transmitted to the contrast delivery system to be used in determining flow rates and delays, etc. Additionally, information relating to image quality or sensed concentration of contrast media is received to allow for automatic adjustment of the system.);
modifying the contrast agent use plan on the basis of the treatment plan that has been modified (Paragraphs [0016], [0024], [0042], and FIG. 5 discuss ECS is capable of sending and receiving information so that, for example, the operator only needs to program the CT scanner with the number of slices and section of the body being imaged and feedback from at least one sensor is employed by the control system to modify the concentration of the contrast media, injection rate, and/or total volume during the injection procedure; an injection procedure which incorporates a sensor for sensing contract concentration in a patient for modifying the injection parameters.); and
outputting the modified contrast agent use plan (Paragraphs [0016] and [0042] discuss sensed concentration of contrast media is received to allow for automatic adjustment of the system.).
Regarding claim 4, Uber discloses wherein the contrast agent use plan includes information regarding an error range of a use amount of a contrast agent (Paragraph [0060] and FIG. 5 discuss calculated concentration of contrast media and other injection parameters are then displayed and the operator reviews and determines whether they are satisfactory and if the results appear to be within the desired range, injection of the contrast media begins.).
Regarding claim 6, Uber discloses wherein the process further comprises:
acquiring a renal condition indicator regarding a condition of a kidney of the patient during treatment (Paragraphs [0052]-[0054] and Table 1 discuss software relies on a variety of factors for calculating the appropriate contrast media concentration and injection parameters for a particular patient including kidney function.);
calculating an intraoperative acceptable amount regarding a contrast agent to be administered to the patient on the basis of the renal condition indicator and the patient information (Paragraphs [0052]-[0054] and Table 1 discuss software relies on a variety of factors for calculating the appropriate contrast media concentration and injection parameters for a particular patient including kidney function.); and
outputting information regarding the calculated intraoperative acceptable amount (Paragraph [0056] discusses the ECS computes the appropriate concentration of contrast media and the injection parameters such as flow rates, volume, and time delay etc. The resultant concentration and injection parameters are then displayed.).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Uber in view of Gelfand (U.S. Pub. No. 2004/0167415 A1).
Regarding claim 20, Uber does not disclose wherein the renal condition indicator is at least one of a urine flow, a urine volume, a urine oxygen tension, and urine color.
Gelfand teaches:
wherein the renal condition indicator is at least one of a urine flow, a urine volume, a urine oxygen tension, and urine color (Paragraphs [0064]-[0066] and FIG. 8 discuss kidney is protected from contrast nephropathy by elevating pressure in the renal pelvis of kidney which affects urine formed and measure of urine flow.).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Uber to include, wherein the renal condition indicator is at least one of a urine flow, a urine volume, a urine oxygen tension, and urine color, as taught by Gelfand, in order to protect vulnerable patients from exposure to high peak concentration of contrast agents. (Gelfand Paragraph [0024].).
Response to Arguments
Applicant’s arguments filed 3/03/2026 have been fully considered.
Rejections under 35 U.S.C. 101:
With respect to claim 1 and the Prong 1 35 U.S.C. 101 rejection, Applicant’s amendment fails to overcome the previous rejection. Claim 1 recites an abstract idea, a method of organizing human activity and/or mathematical concepts. See MPEP 2106.04(a)(2)(II)(C) Managing Personal Behavior or Relationships or Interactions Between People. Applicant states the amended claims are, “directed to a specific technological improvement rather than an abstract idea in that the claimed subject matter is not directed merely to outputting a plan but also includes technical features in the manner and format of the output. Specifically, for example, as shown in Figures 15A and 15B, which are reproduced below, the "contrast agent usage plan" is output as a time-series graphical display that correlates (i) the progress of the treatment plan with (ii) the planned amount of contrast agent usage.” (Remarks, page 13). Examiner respectfully disagrees. Here, Applicant’s claims are directed to outputting a contrast agent injection plan, which is not a technical problem rooted in the technology. The improvement here is to the abstract idea.
Practical application is a way to overcome the Prong 2 35 U.S.C 101 rejection, however, here, the claims do not recite additional elements that integrate the exception into a practical application. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicate that a practical application may be present where the claimed invention provides a technical solution to a technical problem. Applicant states, “Through this distinctive visual representation, a physician can intuitively and accurately grasp the current progress relative to the treatment plan, the remaining allowable amount of contrast agent, and the actual amount already used, thereby enabling safer execution of the procedure.” (Remarks, page 14). The Application, acquiring patient information and creating a treatment plan - is part of the abstract idea and the abstract idea cannot be used to integrate itself into a practical application. Here, the additional elements, including “a computer”, “an information processing device”, “a control unit”, do not result in a practical application or technical improvement, as they are recited at an apply it level, as stated above. Here, the Application is an improvement to the abstract idea and does not improve any computer element.
All components in the claims are being used for their intended purpose and as written do not result in a practical application or significantly more than the abstract idea. Here, individually and in combination, the additional elements do not provide significantly more than the abstract idea. The claims recite features that are "well-understood, routine, conventional activities”. There is no technological improvement to any additional element. For the reasons stated above, claims 7 and 13 similarly fail to overcome the 35 U.S.C. 101 rejection.
Rejections under 35 U.S.C. 102:
The amendment does not overcome the 102 rejection. Applicant states, “Uber does not disclose or suggest acquiring a treatment plan on the basis of the patient information and the surgical procedure information, wherein the treatment plan includes a procedure for performing a series of treatments and an amount of the contrast agent to be administered in the procedure and outputting a contrast agent use plan for the patient on the basis of the treatment plan, wherein the contrast agent use plan includes a form of a graph that indicates a relationship between a progress status of a treatment plan and a scheduled amount of a contrast agent to be used as recited in claims 7 and 13 as amended.” (Remarks, page 16). Examiner respectfully disagrees. Uber does not explicitly state “treatment plan”, however it includes an “injection procedure”, which encompasses a treatment plan. The injection procedure is based on patient data obtained before and during the injection procedure. See Paragraph [0009].
Rejections under 35 U.S.C. 103:
The claim 1 amendment overcomes the previous 35 U.S.C. 103 rejection. Applicant’s arguments with respect to the amended claim have been considered and Examiner’s rejection has been updated to address Applicant’s claim amendments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWN TRINAH HAYNES whose telephone number is (571)270-5994. The examiner can normally be reached M-F 7:30-5:15PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached on (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAWN T. HAYNES/
Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
Prosecution Insights