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 .
Status of Claims
Claims 1-20 has been considered and are addressed below.
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 1-20 are drawn to a computer implemented computer readable non-transitory medium, computer implemented method, system which is/are statutory categories of invention (Step 1: YES).
Independent claims 1 and 20, recite “receiving a plurality of current cardiovascular performance metrics of a patient and a plurality of candidate drugs to be used to reach a plurality of desired cardiovascular performance metrics”, ”determining optimal dosages of the plurality of candidate drugs to reach the plurality of desired cardiovascular performance metrics, the determining comprising:”, “optimizing a dosage combination of the plurality of candidate drugs to reach a plurality of desired cardiovascular parameters, corresponding to the plurality of desired cardiovascular performance metrics, from a plurality of current cardiovascular parameters corresponding to the plurality of current cardiovascular performance metrics”, “mapping the plurality of desired cardiovascular performance metrics from the plurality of desired cardiovascular parameters and the plurality of current cardiovascular performance metrics from the plurality of current cardiovascular parameters” and “outputting the optimal dosages of the plurality of candidate drugs”.
If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea (Step 2A Prong One: YES).
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including a “computer readable non-transitory storage medium”, “computer”, “system”, “one or more processors”, “non-transitory computer readable medium”, which are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed (e.g., the “processor” language is incidental to what it is “configured” to perform). Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The claims recite do not recite additional element which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, 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.
Hence, the 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. Accordingly, 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, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See: MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The originally filed specification supports this conclusion at Figure 1, and
Paragraph 53 recite “The computing device 800 may also perform one or more steps of the methods 500. The computing device 800 is implemented on any electronic device that runs software applications derived from compiled instructions, including without limitation personal computers, servers, smart phones, media players, electronic tablets, game consoles, email devices, etc. In some implementations, the computing device 800 includes one or more processors 802, one or more input devices 804, one or more display devices 806, one or more network interfaces 808, and one or more computer-readable media 812. Each of these components is be coupled by a bus 810”.
The claims recite do not recite additional element which amounts to extra-solution activity concerning mere data gathering. The specification (e.g., as excerpted above) does not provide any indication that the additional elements are anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are here). See: MPEP 2106.05(g).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2-10, 12-19 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein. Additionally, the devices mentioned in dependents claim are used as input devices.
With respect to dependent claim 10 the additional element of displaying the optimal dosages on screen is an extra solution activity.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2022/0093229) in view of Biachi (US 2021/0252017).
With respect to claim 1 Peyman teaches a computer readable non-transitory storage medium storing computer program instructions, that when executed cause operations comprising:
receiving a plurality of current cardiovascular performance metrics of a patient and a plurality of candidate drugs to be used to reach a plurality of desired cardiovascular performance metrics (Peyman paragraph 20 “the method further comprises the steps of monitoring the diagnostic data, the medication data, and a plurality of parameters that affects the medical condition of the patient; updating the medication dose model based on changes in the medication data, the diagnostic data, and the plurality of parameters; and processing the updated medication dose model to calculate a second medication dose for the medical condition. The medical condition can be hypertension. The diagnostic data comprises systolic and diastolic blood pressure of the patient. The medication data comprises details of medicines taken by the patient. The biodata comprises genetic information, physiological information, gender, age, medical history, sleep habits, and physical activities. The plurality of parameters comprises quantified genetic information, medical history, quantified employment details, quantified mental state, energy expenditure, calories intake, partial oxygen, and carbon dioxide saturation levels in blood, and sleep patterns”) which reads on the plurality of cardiovascular performance metrics of a patient;
determining optimal dosage of the plurality of candidate drugs to reach the plurality of desired cardiovascular performance metrics (Peyman paragraph 31 “multiple factors can contribute to hypertension; the disclosed apparatus can provide better management of hypertension by optimizing the medication dose based on the multiple parameters and closely monitoring the effects of the medicine on the patient. Mental diseases like anxiety and depression which are greatly affected by the lifestyle and mood of a patient can also be managed better by optimizing the medication dose based on the actual needs of the patient. Similarly, lifestyle diseases such as diabetes which require management of glucose levels within predetermined limits could be better managed by optimizing the medication dose calculated based on the trends in blood glucose levels over time and physical activities of the patient”),
the determining comprising: optimizing a dosage to reach a plurality of desired cardiovascular parameters, corresponding to the plurality of desired cardiovascular performance metrics, from a plurality of current cardiovascular parameters corresponding to the plurality of current cardiovascular performance metrics; and
mapping the plurality of desired cardiovascular performance metrics from the plurality of desired cardiovascular parameters and the plurality of current cardiovascular performance metrics from the plurality of current cardiovascular parameters (Peyman paragraph 33 “To adjust the medication dose model for a specific patient, the machine learning algorithms can be applied to the prescription and the data based on the pre-trained model to make observations, at step 230. The observations can also be the determining values of different parameters including medication doses. The observations can also be predicted blood pressure values based on the medication of the patient. The observations can be presented for checking at step 240. If an observation matches the criteria set by the medical professional at step 240, the same can be saved at step 250. Else, if the observation is outside the range specified by the medical professional at step 240, feedback can be provided that can help the machine learning algorithm to further adjust the model (learning), at step 270. For example, the predicted blood pressure can be compared with actual blood pressure. At each iteration, multiple factors are continuously monitored, and new data is created at step 280. Eventually, the medical dose model can be validated when the model can predict the values of the blood pressure over a significant period. This period can vary between a few days to a few weeks. During this time, the model can predict the blood pressure values within the range specified by the medical professional. The model calculates these predictions based on the medication taken by the patient and all other data that was input and recorded during this period”); and
outputting the optimal dosages of the candidate drugs (Peyman paragraph 34 “Using the medication dose model 160, the medication dose can be calculated by the machine learning algorithms, at step 330. The calculated medication doses can then be dispensed by the dispensing station,”).
Peyman does not teach plurality of candidate drugs or combination of the plurality of candidate drugs.
Bianchi teaches ““pharmaceutically acceptable carrier” means a chemical composition with which an istaroxime compound or a metabolite of istaroxime may be combined and which, following the combination, can be used to administer the compound to a mammal” (Bianchi paragraph 53).
One of ordinary skill in the art would have been obvious to combine the teachings of Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Claim 11 is rejected as above.
Claim 20 is rejected as above.
With respect to claim 2 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 1. Peyman does not explicitly teach wherein the plurality of current cardiovascular performance metrics and the plurality of desired cardiovascular performance metrics comprise one or more of mean arterial pressure, left atrial pressure, cardiac output, or cardiac index.
Bianchi teaches a non-limiting list of exemplary “parameters” of heart function include heart rate, blood pressure, diastolic relaxation, systolic contraction, LVEF, diastolic blood pressure, systolic blood pressure, cardiac output, stroke volume, deceleration slope, cardiac index, mitral inflow velocity, and the like. As one having ordinary skill in the art will appreciate, measuring one or more “parameters” of heart function can be used to detect heart dysfunction as compared to the average normal parameters and can also be used to determine whether heart function has improved following or during treatment (Bianchi paragraph 56).
One of ordinary skill in the art would have been obvious to combine the teachings of Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Claim 12 is rejected as above.
With respect to claim 3 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 1. Peyman does not teach wherein the plurality of current cardiovascular parameters and the plurality of desired cardiovascular parameters comprise one or more of systemic vascular resistance, cardiac contractility, heart rate, or stressed blood volume.
Bianchi teaches the term “parameter” as used herein to refer to measuring heart function means any heart function that is observable or measurable using suitable measuring techniques available in the art. A non-limiting list of exemplary “parameters” of heart function include heart rate, blood pressure, diastolic relaxation, systolic contraction, LVEF, diastolic blood pressure, systolic blood pressure, cardiac output, stroke volume, deceleration slope, cardiac index, mitral inflow velocity, and the like. As one having ordinary skill in the art will appreciate, measuring one or more “parameters” of heart function can be used to detect heart dysfunction as compared to the average normal parameters and can also be used to determine whether heart function has improved following or during treatment (Bianchi paragraph 56).
One of ordinary skill in the art would have been obvious to combine the teachings of Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Claim 13 is rejected as above.
With respect to claim 4 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 1. Peyman does not explicitly teach, wherein the plurality of candidate drugs comprises at least one of positive inotropes, vasopressors, vasodilators, fluids, or diuretics.
Bianchi teaches future drug classes and/or specific drugs such as: a) drug classes such as, ACE inhibitors, AIRBs, diuretics, Ca channel blockers, .sub.R blockers, digitalis, NO donors, vasodilators, SERCA2a stimulators, neprilysin (NEP) inhibitors, myosin filament activators, recombinant relaxin-2 mediators, recombinant NP protein, activators of the soluble Guanylate Cyclase (sGC), beta-arrestin ligand of Angiotensin II receptor; b) specific drugs: hydrochlorothyzide, furosemide, verapamil, diltiazem, carvedilol, metoprolol, hydralazine, eplerenone, spironolactone, lisinopril, ramipril, nitroglycerin, nitrates, digoxin, valsartan, olmesartan, telmisartan, candesartan, losartan, entresto, omecamtiv, sacubitril, serelaxin, ularitide, levosimendan, cinaciguat (Bianchi paragraph 143).
One of ordinary skill in the art would have been obvious to combine the teachings of Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Claim 14 is rejected as above.
With respect to claim 5 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 1. Peyman does not explicitly teach wherein the optimal dosages of the plurality of candidate drugs is constrained by a linear relationship between the plurality of candidate drugs, the plurality of current cardiovascular parameters, and the plurality of desired cardiovascular parameters.
Bianchi teaches primary efficacy endpoint: Analysis The primary efficacy endpoint (change from baseline in E/Ea ratio) will be analyzed using a linear mixed model for repeated measures including treatment, centre, timepoint, gender, baseline (Bianchi paragraph 71 Table 1).
One of ordinary skill in the art would have been obvious to combine the teachings of Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Claim 15 is rejected as above.
With respect to claim 6 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 1, wherein the optimal dosages of the plurality of candidate drugs is constrained by a maximum dosage limitation of each of the plurality of candidate drugs (Peyman paragraph 37).
Claim 16 is rejected as above.
With respect to claim 7 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 1. Peyman does not teach wherein the mapping of the plurality of desired cardiovascular performance metrics from the plurality of desired cardiovascular parameters is based on a hemodynamics analysis.
Bianchi teaches Change in 12-lead ECG parameters; Incidence of clinically or hemodynamically significant episodes of supraventricular or ventricular arrhythmias detected by continuous ECG dynamic monitoring (Bianchi paragraph 71 Table 1).
One of ordinary skill in the art would have been obvious to combine the teachings of Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Claim 17 is rejected as above.
With respect to claim 8 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 7. Peyman does not teach wherein the hemodynamics analysis comprises analytically deriving the plurality of desired cardiovascular performance metrics from the plurality of desired cardiovascular parameters.
Bianchi teaches Change in 12-lead ECG parameters; Incidence of clinically or hemodynamically significant episodes of supraventricular or ventricular arrhythmias detected by continuous ECG dynamic monitoring (Bianchi paragraph 71 Table 1).
One of ordinary skill in the art would have been obvious to combine the teachings of Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Claim 18 is rejected as above.
With respect to claim 9 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 7 Peyman does not teach wherein the hemodynamics analysis comprises numerically determining the plurality of desired cardiovascular parameters based on a filtering using the plurality of desired cardiovascular performance metrics.
Bianchi teaches Change in 12-lead ECG parameters; Incidence of clinically or hemodynamically significant episodes of supraventricular or ventricular arrhythmias detected by continuous ECG dynamic monitoring (Bianchi paragraph 71 Table 1).
One of ordinary skill in the art would have been obvious to combine the teachings of Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Claim 19 is rejected as above.
With respect to claim 10 Peyman in view of Bianchi teaches the computer readable non-transitory storage medium of claim 1 wherein outputting the optimal dosages of the plurality of candidate drugs comprises: displaying the optimal dosages on a screen.
Bianchi teaches Table 5 shows the echocardiographic parameters in STZ diabetic rats before and after 15 and 30 min from iv infusion of PST 3093 at 0.22 mg/kg, and 10 min after interruption of infusion. Data is presented as mean±SD, and values with an asterisk are statistically significant with at least p<0.05. (Bianchi paragraph 210). One of ordinary skill in the art would have been obvious to combine the teachings of
Peyman with Bianchi at the time of filing with the motivation of improving the symptoms and reducing the incidence of unwanted side effects produced by the available drugs (Bianchi paragraph 122).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINALD R REYES whose telephone number is (571)270-5212. The examiner can normally be reached 8:00-4:30 M-F.
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REGINALD R. REYES
Primary Examiner
Art Unit 3684
/REGINALD R REYES/Primary Examiner, Art Unit 3684