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 .
Response to Amendment
In light of the amendments, the claims are rejected under 35 U.S.C. 101.
In light of the amendments, the claims are rejected under 35 U.S.C. 103.
Notice to Applicant
In the amendment dated 11/28/2025, the following has occurred: claims 1, 6-8, 14, and 20 have been amended; claims 2-5, 9,13, and 15-19 remain unchanged; and no new claims have been added.
Claims 1-20 are pending.
Effective Filing Date: 03/31/2022
Response to Arguments
35 U.S.C. 101 Rejections:
Applicant argues with respect to the newly-amended independent claims and states that the claims are integrated into a practical application in Step 2A, Prong Two. Examiner however respectfully disagrees. The additional limitations are mostly included as part of the abstract idea.
35 U.S.C. 103 Rejections:
Applicant argues with respect to the newly-amended claim limitations. These arguments are deemed moot in view of the amendments to the claims requiring further art to address.
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 1-20 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 1-13 are drawn to a medium, claims 14-19 are drawn to a method, and claim 20 is drawn to a device, each of which is within the four statutory categories. Claims 1-20 are further directed to an abstract idea on the grounds set out in detail below. As discussed below, the claims do not include additional elements that are sufficient to amount to significantly more than the abstract idea because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea (Step 1: YES).
Step 2A:
Prong One:
Claim 1 recites a) a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process comprising:
1) acquiring a renal condition indicator regarding a condition of a kidney of a patient during a treatment;
2) calculating an intraoperative acceptable amount regarding a contrast agent to be administered to the patient on the basis of the renal condition indicator and patient information;
3) acquiring an administered amount of the contrast agent administered to the patient; and
4) outputting information regarding the intraoperative acceptable amount to b) a display system, the display system including a screen that includes a dosage gauge and the administered amount of the contrast agent, the dosage gauge being a relationship between the intraoperative acceptable amount of the contrast agent and the administered amount of the contrast agent in a plurality of stages, and wherein each of the plurality of stages is an increment of a total amount of the intraoperative acceptable amount of the contrast agent.
Claim 1 recites, in part, performing the steps of 1) acquiring a renal condition indicator regarding a condition of a kidney of a patient during a treatment, 2) calculating an intraoperative acceptable amount regarding a contrast agent to be administered to the patient on the basis of the renal condition indicator and patient information, and 3) acquiring an administered amount of the contrast agent administered to the patient, and 4) outputting information regarding the intraoperative acceptable amount to a display (when a piece of paper), the display including a screen that includes a dosage gauge and the administered amount of the contrast agent, the dosage gauge being a relationship between the intraoperative acceptable amount of the contrast agent and the administered amount of the contrast agent in a plurality of stages, and wherein each of the plurality of stages is an increment of a total amount of the intraoperative acceptable amount of the contrast agent. These steps correspond to Certain Methods of Organizing Human Activity, more particularly, managing personal behavior or relationships or interactions between people (including following rules or instructions). For example, the claim recites steps that a person could perform in order to determine an acceptable amount of contrast to use. Independent claims 14 and 20 recites similar limitations and are also directed to an abstract idea under the same analysis.
Depending claims 2-13 and 15-19 include all of the limitations of claims 1, 14, and 20, and therefore likewise incorporate the above described abstract idea. Depending claims 2 and 15 add the additional step of “acquiring the intraoperative acceptable amount by inputting the patient information, the renal condition indicator, and circulatory dynamics information of the patient to a trained model configured to output the intraoperative acceptable amount when receiving the patient information, the renal condition indicator, and the circulatory dynamics information”; claims 5 and 18 add the additional steps of “sequentially acquiring the renal condition indicator”, “calculating a future renal condition indicator on the basis of a temporal change in the renal condition indicator”, and “outputting the calculated future renal condition indicator”; claims 6 and 19 add the additional steps of “outputting a risk that the patient develops renal damage on the basis of the administered amount of the contrast agent and the intraoperative acceptable amount”; claim 7 adds the additional steps of “outputting a control signal to a contrast agent administration pump on the basis of a difference between the intraoperative acceptable amount and the administered amount of the contrast agent”; claim 8 adds the additional step of “outputting the renal condition indicator to the display system”; claim 9 adds the additional step of “outputting a calculation error of the intraoperative acceptable amount together with information regarding the intraoperative acceptable amount”; and claim 11 adds the additional step of “outputting a report regarding a status of administering the contrast agent after the treatment for the patient is completed”. Additionally, the limitations of depending claims 3-4, 10, 12-13, and 16-17 further specify elements from the claims from which they depend on without adding any additional steps. These additional limitations only further serve to limit the abstract idea. Thus, depending claims 2-13 and 15-19 are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 14, and 20 (Step 2A (Prong One): YES).
Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of – using a) a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process, b) a display system, the display system including a screen, c) a computer (in claim 14), and d) an information processing device comprising a control unit (in claim 20) to perform the claimed steps.
The a) non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process, c) computer, and d) an information processing device comprising a control unit in these steps are recited at a high-level of generality (i.e., as generic components performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components (see: Applicant’s specification, paragraph [0143] where there is a general-purpose computer, see MPEP 2106.05(f)).
Additionally, the b) display system, the display system including a screen in these steps adds insignificant extra-solution activity to the abstract idea which amounts to insignificant application, see MPEP 2106.05(g).
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea (Step 2A (Prong Two): NO).
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a) a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process, b) a display system, the display system including a screen, c) a computer, and d) an information processing device comprising a control unit to perform the claimed steps amounts to no more than insignificant extra-solution activity in the form of WURC activity (well-understood, routine, and conventional activity), a general linking to a particular technological field, or mere instructions to apply the exception using a generic computer component that does not offer “significantly more” than the abstract idea itself because the claims do not recite an improvement to another technology or technical field, an improvement to the functioning of any computer itself, or provide meaningful limitations beyond generally linking an abstract idea to a particular technological environment. It should be noted that the claims do not include additional elements that amount to significantly more than the judicial exception because the Specification recites mere generic computer components, as discussed above that are being used to apply certain method steps of organizing human activity. Specifically, MPEP 2106.05(d) MPEP 2106.05(f) recites that the following limitations are not significantly more:
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)); and
Adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 134 S. Ct. at 2360, 110 USPQ2d at 1984 (see MPEP § 2106.05(f)).
The current invention outputs an acceptable amount utilizing a) a non-transitory computer-readable medium, c) a computer, and d) an information processing device, thus these computing components are adding the words “apply it” with mere instructions to implement the abstract idea on a computer.
Furthermore, the b) display system, the display system including a screen in these steps add insignificant extra-solution activity/pre-solution activity in the form of WURC activity to the abstract idea. The following is an example of a court decision demonstrating computer functions as well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II): Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives data of an acceptable amount, and transmits the data to display system over a network, for example the Internet.
Mere instructions to apply an exception using generic computer components or insignificant extra-solution activity in the form of WURC activity cannot provide an inventive concept. The claims are not patent eligible (Step 2B: NO).
Claims 1-20 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 6-8, 11-14, 17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2010/0114064 to Kalafut et al. in view of U.S. 2013/0276799 to Davidson et al.
As per claim 1, Kalafut et al. teaches a non-transitory computer-readable medium storing a computer readable program that causes a computer to execute a process comprising:
--acquiring a renal condition indicator regarding a condition of a kidney of a patient during a treatment; (see: paragraph [0072] where there is information inputted in the form of if existing renal insufficiency exists. This could be for a patient during a treatment. Also see: paragraphs [0100] – [0102])
--calculating an intraoperative acceptable amount regarding a contrast agent to be administered to the patient on the basis of the renal condition indicator and patient information; (see: paragraph [0071] where there is calculation of a recommended amount of contrast to be given to the patient. This information is based on patient information (such as weight and height of the individual) and renal condition indicator (if the person is experiencing existing insufficiency) as shown in paragraph [0072])
--acquiring an administered amount of the contrast agent administered to the patient; (see: paragraph [0076] where the administered dose amount is being received as notifications are being sent if this amount exceeds a threshold) and
--outputting information regarding the intraoperative acceptable amount to a display system (see: paragraph [0073] where there is outputting of CIN risk assessment information on a display screen which includes a recommended amount of contrast).
Kalafut et al. teaches a liquid as a contrast agent in paragraph [0073] may not further, specifically teach:
1) --the display system including a screen that includes a dosage gauge and the administered amount of the liquid, the dosage gauge being a relationship between the intraoperative acceptable amount of the liquid and the administered amount of the liquid in a plurality of stages, and wherein each of the plurality of stages is an increment of a total amount of the intraoperative acceptable amount of the liquid.
Davidson et al. teaches:
1) --the display system including a screen that includes a dosage gauge and the administered amount of the liquid, (see: paragraph [0241] where there is display of a dosage gauge and the administered amount of contrast in the form of a percentage of dosage delivered or remaining) the dosage gauge being a relationship between the intraoperative acceptable amount of the liquid and the administered amount of the liquid in a plurality of stages, (see: paragraph [0124] where there is a dosage gauge in the form of a percentage of dosage delivered or remaining. The percentage here is a relationship between the acceptable amount of the liquid (indicated by 0% remaining or 100% delivered) and the administered amount (percentage delivered). The stages can correspond to the numeral representation as a percentage, for example, 10%, 20%, etc.) and wherein each of the plurality of stages is an increment of a total amount of the intraoperative acceptable amount of the liquid (see: paragraph [0124] where the stages can correspond to the numeral representation as a percentage, for example, 10%, 20%, etc. of the total, acceptable amount).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have 1) the display system include a screen that includes a dosage gauge and the administered amount of the contrast agent, the dosage gauge being a relationship between the intraoperative acceptable amount of the contrast agent and the administered amount of the contrast agent in a plurality of stages, and wherein each of the plurality of stages is an increment of a total amount of the intraoperative acceptable amount of the contrast agent as taught by Davidson et al. in the medium as taught by Kalafut et al. with the motivation(s) of providing a constantly updated clinical and statistical data on the used substance (see: paragraph [0144] of Davidson et al.).
As per claim 4, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches wherein the renal condition indicator is at least one of a urine flow, a urine volume, a urine oxygen tension, and a urine color (see: paragraph [0072] where recent urine volume may be the received information).
As per claim 6, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches wherein the process further comprises:
--outputting a risk that the patient develops renal damage on the basis of the administered amount of the contrast agent and the intraoperative acceptable amount (see: paragraph [0076] where there is an outputting of a CIN risk level during the procedure. Also see: paragraph [0071] where there is an outputting of an acceptable amount of contrast for the patient and paragraph [0077] where the CIN risk assessment provides information on the patient’s status).
As per claim 7, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches wherein the process further comprises:
--outputting a control signal to a contrast agent administration pump on the basis of a difference between the intraoperative acceptable amount and the administered amount of the contrast agent (see: paragraphs [0076] and [0079] where there is an automatic adjusting of the contrast injection parameters).
As per claim 8, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches wherein the process further comprises:
--outputting the renal condition indicator to the display system (see: FIG. 9D and paragraph [0100] where there is outputting of a renal condition indicator on a display).
As per claim 11, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches wherein the process further comprises:
--outputting a report regarding a status of administering the contrast agent after the treatment for the patient is completed (see: paragraphs [0070] and [0079] where after the procedure a clinician is being provided with feedback regarding the recommended course of treatment. Also see: paragraph [0098] where after the contrast is completed there is a determination of if the patient will experience complications. A report is being outputted regarding the status of administering the contrast agent in the form of if there will be complications).
As per claim 12, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 11, see discussion of claim 11. Kalafut et al. further teaches wherein the report includes the intraoperative acceptable amount, an amount of the contrast agent administered to the patient, or a risk that the patient develops a complication (see: paragraph [0098] where there is outputting of the likelihood of a patient developing complications).
As per claim 13, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches wherein the patient information includes information regarding the contrast agent previously administered to the patient (see: paragraph [0075] where there is dose history for the patient which is included as part of the patient data).
As per claim 14, claim 14 is similar to claim 1 and is therefore rejected in a similar manner to claim 1.
As per claim 17, Kalafut et al. and Davidson et al. in combination teaches the method of claim 14, see discussion of claim 14. Kalafut et al. further teaches wherein the renal condition indicator is at least one of a urine flow, a urine volume, a urine oxygen tension, and a urine color (see: paragraph [0072] where recent urine volume may be the received information).
As per claim 19, Kalafut et al. and Davidson et al. in combination teaches the method of claim 14, see discussion of claim 14. Kalafut et al. further teaches:
--acquiring an administered amount of the contrast agent administered to the patient; (see: paragraph [0076] where the administered dose amount is being received as notifications are being sent if this amount exceeds a threshold) and
--outputting a risk that the patient develops renal damage on the basis of the administered amount of the contrast agent and the intraoperative acceptable amount (see: paragraph [0076] where there is an outputting of a CIN risk level during the procedure. Also see: paragraph [0071] where there is an outputting of an acceptable amount of contrast for the patient and paragraph [0077] where the CIN risk assessment provides information on the patient’s status).
As per claim 20, claim 20 is similar to claim 1 and is therefore rejected in a similar manner to claim 1.
Claims 2-3, 9, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2010/0114064 to Kalafut et al. in view of U.S. 2013/0276799 to Davidson et al. as applied to claims 1 and 14, and further in view of U.S. Patent No. 12,347,538 to Inwald et al..
As per claim 2, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches wherein the patient information includes background information regarding the patient and medical history information of the patient, (see: paragraph [0072] where there is history information for a patient and information regarding the patient including their height and weight) and the process further comprises:
--acquiring the intraoperative acceptable amount by inputting the patient information, the renal condition indicator, and circulatory dynamics information of the patient to a model configured to output the intraoperative acceptable amount when receiving the patient information, the renal condition indicator, and the circulatory dynamics information (see: paragraph [0072] where there is circulatory dynamics information (blood pressure), renal condition indicator (existing renal insufficiency exists?), and patient information (height, weight, etc.) into a risk assessment computer program (a model configured to output an acceptable amount of contrast)).
Kalafut et al. and Davidson et al. in combination may not further, specifically teach:
--a trained model.
Inwald et al. teaches:
--a trained model (see: column 3, lines 26-37 where there is a trained model which is used).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a trained model as taught by Inwald et al. for the model as disclosed by Kalafut et al. and Davidson et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Kalafut et al. and Davidson et al. already teaches of using a model, thus one could replace that with a trained model to obtain predictable results of using a model to output information. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 3, Kalafut et al., Davidson et al., and Inwald et al. in combination teaches the medium of claim 2, see discussion of claim 2. Kalafut et al. further teaches wherein the circulatory dynamics information includes at least one of a pulse pressure, an average blood pressure, a heart rate, blood oxygen saturation, tissue oxygen saturation, and an intravesical pressure (see: paragraph [0072] where there is blood pressure which is part of the circulatory dynamics).
As per claim 9, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches an amount as an intraoperative acceptable amount (see: paragraph [0071] where there is an accepted amount).
Kalafut et al. and Davidson et al. in combination may not further, specifically teach wherein the process further comprises:
--outputting a calculation error of the amount together with information regarding the amount.
Inwald et al. teaches:
--wherein the process further comprises:
--outputting a calculation error of the intraoperative acceptable amount together with information regarding the intraoperative acceptable amount (see: column 4, lines 11-28 and claim 1 where there is an outputting of information including a range of acceptable dosage for a medication. The range here is a calculation of error and includes the amount).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the process further comprises: outputting a calculation error of the intraoperative acceptable amount together with information regarding the intraoperative acceptable amount as taught by Inwald et al. in the medium as taught by Kalafut et al. and Davidson et al. in combination with the motivation(s) of suggesting an appropriate amount of dosage for a drug (see: column 2, lines 34-36 of Inwald et al.).
As per claim 15, Kalafut et al. and Davidson et al. in combination teaches the method of claim 14, see discussion of claim 14. Kalafut et al. further teaches wherein the patient information includes background information regarding the patient and medical history information of the patient, (see: paragraph [0072] where there is history information for a patient and information regarding the patient including their height and weight) and the method further comprises:
--acquiring the intraoperative acceptable amount by inputting the patient information, the renal condition indicator, and circulatory dynamics information of the patient to a model configured to output the intraoperative acceptable amount when receiving the patient information, the renal condition indicator, and the circulatory dynamics information (see: paragraph [0072] where there is circulatory dynamics information (blood pressure), renal condition indicator (existing renal insufficiency exists?), and patient information (height, weight, etc.) into a risk assessment computer program (a model configured to output an acceptable amount of contrast)).
Kalafut et al. and Davidson et al. in combination may not further, specifically teach:
--a trained model.
Inwald et al. teaches:
--a trained model (see: column 3, lines 26-37 where there is a trained model which is used).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute a trained model as taught by Inwald et al. for the model as disclosed by Kalafut et al. and Davidson et al. in combination since each individual element and its function are shown in the prior art, with the difference being the substitution of the elements. In the present case, the combination of Kalafut et al. and Davidson et al. already teaches of using a model, thus one could replace that with a trained model to obtain predictable results of using a model to output information. Thus, one of ordinary skill in the art could have substituted the one known element for the other to produce a predictable result (MPEP 2143).
As per claim 16, Kalafut et al., Davidson et al., and Inwald et al. in combination teaches the method of claim 15, see discussion of claim 15. Kalafut et al. further teaches wherein the circulatory dynamics information includes at least one of a pulse pressure, an average blood pressure, a heart rate, blood oxygen saturation, tissue oxygen saturation, and an intravesical pressure (see: paragraph [0072] where there is blood pressure which is part of the circulatory dynamics).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2010/0114064 to Kalafut et al. in view of U.S. 2013/0276799 to Davidson et al. as applied to claims 1 and 14, and further in view of U.S. 2022/0095977 to Ancona et al.
As per claim 5, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches wherein the process further comprises:
--sequentially acquiring the renal condition indicator; (see: paragraph [0082] where there is information which is gathered over time and used in order to predict the time needed for sufficient levels of contrast to clear. A renal condition indicator (clearance rate information for the person) is being collected over time)
--calculating a future renal condition indicator on the basis of a temporal change in the renal condition indicator; (see: paragraph [0082] where there is information which is gathered over time and used in order to predict the time needed for sufficient levels of contrast to clear. A prediction of a future clearance rate/time needed to contrast to clear is being calculated here).
Kalafut et al. and Davidson et al. in combination may not further, specifically teach:
--outputting the calculated future renal condition indicator.
Ancona et al. teaches:
--outputting the calculated future renal condition indicator (see: paragraph [0025] where this invention is about predicting the onset of renal insufficiency. Also see: paragraph [0126] where there is display of all raw and processed data).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to output the calculated future renal condition indicator as taught by Acuna et al. in the medium as taught by Kalafut et al. and Davidson et al. in combination with the motivation(s) of evaluating kidney function (see: paragraph [0003] of Acuna et al.).
As per claim 18, Kalafut et al. and Davidson et al. in combination teaches the method of claim 14, see discussion of claim 14. Kalafut et al. further teaches:
--sequentially acquiring the renal condition indicator; (see: paragraph [0082] where there is information which is gathered over time and used in order to predict the time needed for sufficient levels of contrast to clear. A renal condition indicator (clearance rate information for the person) is being collected over time)
--calculating a future renal condition indicator on the basis of a temporal change in the renal condition indicator; (see: paragraph [0082] where there is information which is gathered over time and used in order to predict the time needed for sufficient levels of contrast to clear. A prediction of a future clearance rate/time needed to contrast to clear is being calculated here).
Kalafut et al. and Davidson et al. in combination may not further, specifically teach:
--outputting the calculated future renal condition indicator.
Ancona et al. teaches:
--outputting the calculated future renal condition indicator (see: paragraph [0025] where this invention is about predicting the onset of renal insufficiency. Also see: paragraph [0126] where there is display of all raw and processed data).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to output the calculated future renal condition indicator as taught by Acuna et al. in the method as taught by Kalafut et al. and Davidson et al. in combination with the motivation(s) of evaluating kidney function (see: paragraph [0003] of Acuna et al.).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2010/0114064 to Kalafut et al. in view of U.S. 2013/0276799 to Davidson et al. as applied to claims 1 and 14, and further in view of U.S. 2022/0172816 to Mensinger et al.
As per claim 10, Kalafut et al. and Davidson et al. in combination teaches the medium of claim 1, see discussion of claim 1. Kalafut et al. further teaches an amount as an intraoperative acceptable amount (see: paragraph [0071] where there is an accepted amount).
Kalafut et al. and Davidson et al. in combination may not further, specifically teach wherein the information regarding the amount is a value obtained by setting a safety factor to the calculated amount.
Mensinger et al. teaches:
--wherein the information regarding the amount is a value obtained by setting a safety factor to the calculated amount (see: paragraph [0247] where there is information regarding a safety factor which is factored in when making a determination of a medication amount).
One of ordinary skill before the effective filing date of the claimed invention would have found it obvious to have wherein the information regarding the amount is a value obtained by setting a safety factor to the calculated amount as taught by Mensinger et al. in the medium as taught by Kalafut et al. and Davidson et al. in combination with the motivation(s) of customizing a dose for a patient (see: paragraph [0004] of Mensinger et al.).
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 Steven G.S. Sanghera whose telephone number is (571)272-6873. The examiner can normally be reached M-F 7:30-5:00 (alternating Fri).
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/STEVEN G.S. SANGHERA/Primary Examiner, Art Unit 3684