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 .
Status of the Claims
The office action is in response to the claims filed on August 30, 2023 for the application filed on April 26, 2023, which is a national stage of International Application No. PCT/IB2021/059864 filed on October 26, 2021, which claims priority to Italian Application No. IT102020000025801 filed on October 30, 2020. Claims 1-12 and 14-17 are currently pending and have been examined as discussed below.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Italy on October 30, 2020. It is noted, however, that the Italian application is a non-English application.
When a claim to priority and the certified copy of the foreign application are received while the application is pending before the examiner, the examiner should review the certified copy to see that it contains no obvious formal defects and that it corresponds in number, date and country to the application identified in the application data sheet for an application filed on or after September 16, 2012, or oath or declaration or application data sheet for an application filed prior to September 16, 2012. See MPEP 215(I).
Applicant cannot rely upon the certified copy of the foreign priority application to overcome the rejections unless a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP 215 and 216.
Accordingly, the Office requires that English language translation of the non-English language application be filed, with the translation being that of the certified copy of the Italian application as filed and submitted together with a statement that the translation of the associated certified copy is accurate.
Claim Objections
Claims 1, 3, and 9-12 are objected to because of the following informalities: the limitation of “wherein this method is optionally implemented by computer” in claims 1, 3, and 9-12 should be replaced with “wherein the method is optionally implemented by a computer”. Appropriate correction is required.
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 1-12 and 14-17 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.
Examiners should determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance with the flowchart in MPEP 2016(III).
Pursuant to the flowchart, Step 1 relates to the statutory categories and ensures that the first criterion is met by confirming that the claim falls within one of the four statutory categories of invention. Id. If the claim as a whole falls within one or more statutory categories (Step 1: YES), the claim must be further analyzed to determine whether it qualifies as eligible at Pathway A or requires further analysis at Step 2A to determine if the claim is directed to a judicial exception. See MPEP 2106.03(II).
For purposes of efficiency in examination, examiners may use a streamlined eligibility analysis (Pathway A) when the eligibility of the claim is self-evident, e.g., because the claim clearly improves a technology or computer functionality. See MPEP 2016.06. However, if there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself, the full eligibility analysis (the Alice/Mayo test described in MPEP 2106(III)) should be conducted to determine whether the claim integrates the judicial exception into a practical application or recites significantly more than the judicial exception. Id. Of particular interest, claims that could have been found eligible at Pathway A (streamlined analysis), but are subjected to further analysis at Steps 2A or Step 2B, will ultimately be found eligible at Pathways B or C. See MPEP 2016(III). Thus, if the examiner is uncertain about whether a streamlined analysis is appropriate, the examiner is encouraged to conduct a full eligibility analysis. Id.
Step 2, which is the Supreme Court’s Alice/Mayo test, is a two-part test to identify claims that are directed to a judicial exception (Step 2A) and to then evaluate if additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception). See MPEP 2106(III).
Eligibility Step 1:
Under Step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim as a whole falls within one of the statutory categories of invention (i.e., a process, machine, manufacture, or composition of matter). See MPEP 2106.03. In the instant application, claims 1, 2, 4, and 6-8 are directed to a method (i.e., a process); claims 3, 5, 8, and 15-17 are directed to a method (i.e., a process); claim 9 is directed to a method (i.e., a process); claim 10 is directed to a method (i.e., a process); claim 11 is directed to a method (i.e., a process); and claim 12 is directed to a method (i.e., a process).
While each one of claims 1-12 and 14-17 appears to fall within one or more statutory categories of invention, the Office has determined that the full eligibility analysis is required because there is doubt as to whether the applicant is effectively seeking coverage for a judicial exception itself. The eligibility of each claim is not self-evident at least because each claim as a whole did not appear to clearly improve a technology or computer functionality. To the contrary, each claim as a whole appeared to merely apply one or more judicial exceptions on a computer.
Accordingly, it has been determined that each one of claims 1-12 and 14-17 as a whole falls within one or more statutory categories under Step 1, and the Office proceeds with the full eligibility analysis (the Alice/Mayo test described in MPEP 2106(III)) as discussed below.
Eligibility Step 2A, Prong One:
Under Step 2A, Prong One of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether each claim is directed to one or more of the judicial exceptions (i.e., an abstract idea, law of nature, or natural phenomenon). See MPEP 2106.04(II)(A)(1). After evaluation, it has been determined that claims 1-12 and 14-17 are directed to judicial exceptions because claims 1-12 and 14-17 recite abstract ideas. (The Office will not determine that a claim is not directed to a judicial exception under Step 2A, Prong One for the mere reason that claim further recites one or more additional elements beyond the judicial exception.)
The abstract idea exception includes three groupings: (i) mathematical concepts, (ii) certain methods of organizing human activities (“CMOHA”), and (iii) mental processes. See MPEP 2106.04(a). The CMOHA grouping includes three sub-groupings: (i) "fundamental economic practices" or "fundamental economic principles," (ii) "commercial interactions" or "legal interactions"; and (iii) "managing personal behavior or relationships or interactions between people." See MPEP 2106.04(a). The sub-grouping "managing personal behavior or relationships or interactions between people" includes social activities, teaching, and following rules or instructions. See MPEP 2106.04(a)(2)(II)(C). The "mental processes" grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. See MPEP 2106.04(a)(2)(III). The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). Claims can recite a mental process even if they are claimed as being performed on a computer. See MPEP 2106.04(a)(2)(III)(c).
Independent claims 1, 3, and 9-12 are determined to be directed to a judicial exception (e.g., an abstract idea).
Regarding claims 1, 9 and 10, representative claim 1 recites an abstract idea (i.e., mathematical concept, mental process, and/or CMOHA) identified in bold as a method for diagnosing a cardiac or pulmonary disease (mathematical concept, mental process and/or CMOHA) comprising the following steps:
providing a set of physiological parameters of a subject at rest, wherein said parameters have been measured at a time t1, said physiological parameters being selected from exhaled CO2 volume per minute (VCO2), cardiac output (Qt), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a);
calculating the pulmonary blood flow (FPst1) from said set of parameters of step a) according to one or both of the following algorithms: (mathematical concept, mental process and/or CMOHA)
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and calculating the ratio FPst1/Qtt1: (mathematical concept, mental process and/or CMOHA)
providing a second set of physiological parameters of a subject at rest, wherein said parameters have been measured at a time t2 subsequent to t1 by 24 hours or less, said physiological parameters being selected from exhaled CO2 volume per minute (VCO2), cardiac output (Qt), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a);
calculating the pulmonary blood flow (FPst2) from said set of parameters of step c) according to one or both algorithms of step b) and calculating the ratio FPst2/Qtt2 (mathematical concept, mental process and/or CMOHA);
if the ratio FPst1/Qtt1 calculated in step b) is substantially equal to the ratio FPst2/Qtt2 calculated in step d) and is equal to a reference value, said reference value being between 0.97 and 0.985, and if FPst1 is substantially equal to FPst2, and therefore the ratio FPst2/FPst1 is approximately equal to 1, comparing the calculated FPs value with a reference FPs value, said reference FPs value being between 4.00 and 4.6 (mathematical concept, mental process and/or CMOHA), wherein;
a FPs/Qt value between 0.97 and 0.985 and a FPs value between 4.00 and 4.6 is indicative of a normal value or of a subject with class I chronic heart failure (CHF) (classification NYHA) (mathematical concept, mental process and/or CMOHA);
a FPs/Qt value between 0.90 and 0.977 and a FPs value between more than 4.6 and 5.49 is indicative of a value of a subject with class II CHF (NYHA classification) (mathematical concept, mental process and/or CMOHA);
a FPs/Qt value less than 0.90 and a FPs value greater than or equal to about 5.5 is indicative of a value of a subject with class Ill CHF (NYHA classification) (mathematical concept, mental process and/or CMOHA);
a FPs/Qt value between 0.82 and 0.9 and a FPs value between 4 and 4.6 is indicative of class I pulmonary hypertension (PH) (WHO/NYHA classification) (mathematical concept, mental process and/or CMOHA);
a FPs/Qt value between 0.60 and 0.81 and a FPs value between 3.6 and 3.99 is indicative of class II pulmonary hypertension (PH) (WHO/NYHA classification) (mathematical concept, mental process and/or CMOHA);
a FPs/Qt value between 0.40 and 0.59 and a FPs value between 2.4 and 3.599 is indicative of class III pulmonary hypertension (PH) (WHO/NYHA classification) (mathematical concept, mental process and/or CMOHA); and
a FPs/Qt value between 0.65 and 0.85 and a FPs value of less than 2.4 is indicative of class IV pulmonary hypertension (PH) (WHO/NYHA classification) and/or class IV CHF (NYHA classification) (mathematical concept, mental process and/or CMOHA);
if FPst1 is substantially greater than FPst2 so that the ratio FPst2/FPst1 is less than 0.85 and FPSt1/Qtt1 is greater than FPst2/Qtt2 and the delta thereof is between 0.585 and 0.085 and if the subject does not suffer from altitude sickness and/or high-altitude pulmonary edema (HAPE) caused by high-altitude hypoxia or does not suffer from air embolism from scuba diving with tanks and has not taken vasoconstrictive drugs, such as acetazolamide, a FPst2 value substantially less than 4.00 is indicative of suspected pulmonary thromboembolism (mathematical concept, mental process and/or CMOHA),
wherein [the] method is optionally implemented (mathematical concept, mental process and/or CMOHA) by [a] computer.
Claim 9 further recites the abstract idea identified in bold as a method for evaluating a subject's achievement of a maximum effort condition during an exercise, in particular for a heart examination under effort or the like (mathematical concept, mental process and/or CMOHA), the method comprising the following steps:
providing a set of physiological parameters of said subject under effort, said physiological parameters being chosen from exhaled CO2 volume per minute (VCO2), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a; and (mathematical concept, mental process and/or CMOHA) (This step (i) is overlapped by step (a) of claim 1. However, while step (a) of claim 1 recites providing the set of physiological parameters of said subject at rest, step (i) recites providing the set of physiological parameters of said subject under effort. Step (i) is referenced in step (ii) below.)
calculating the pulmonary blood flow (FPs) from said set of parameters of step i) according to the following algorithm (mathematical concept, mental process and/or CMOHA):
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(mathematical concept, mental process and/or CMOHA) (Step (ii) is overlapped by step (b) in claim 1. The FPs (i.e., calculated in step (ii)) is referenced in step (iii) below.)
calculating [a max] ratio (mathematical concept, mental process and/or CMOHA)
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wherein the subject has reached the maximum effort if [the max ratio
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] is ≤ 5.86. (mathematical concept, mental process and/or CMOHA)
Claim 10 further recites the abstract idea identified in bold as a method for checking the validity of cardiac output (Qt) measurements and immediate detection of a measurement error (mathematical concept, mental process and/or CMOHA), comprising:
1) calculating FPs with said algorithm B (mathematical concept, mental process and/or CMOHA); and
2) comparing the Qt value with the FPs value (mental process and/or CMOHA):
2.1) if Qt is greater than FPs, the Qt measurement is correct (mathematical concept, mental process and/or CMOHA), and
2.2) if Qt is less than FPs, the Qt measurement is incorrect (underestimated) (mathematical concept, mental process and/or CMOHA).
Claim 3 recites an abstract idea identified in bold as a method of diagnosing CHF (mental process and/or CMOHA), comprising the following steps:
a1. providing a set of physiological parameters of a subject at rest, said physiological parameters being chosen from exhaled CO2 volume per minute (VCO2), cardiac output (Qt), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a); (mathematical concept, mental process and/or CMOHA) (This step (a1) is overlapped by step (a) of claim 1 and is referenced in step (b1) below.)
a2. providing a set of physiological parameters of said subject under maximum effort, said physiological parameters being chosen from exhaled CO2 volume per minute (VCO2), cardiac output (Qt), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a); (mathematical concept, mental process and/or CMOHA) (This step (a2) is overlapped by step (c) of claim 1. However, while step (c) of claim 1 recites “providing a second set of physiological parameters of a subject at rest, wherein said parameters have been measured at a time t2 subsequent to t1 by 24 hours or less,” step (a2) recites “providing a set of physiological parameters of said subject under maximum effort” and is referenced in step (b1) below.)
b1. calculating the pulmonary blood flow (FPsa1) from said set of parameters of step a1) and the pulmonary blood flow (FPsa2) from said set of parameters of step a2) according to one or both of the following algorithms (mathematical concept, mental process and/or CMOHA):
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(mathematical concept, mental process and/or CMOHA)
c1. comparing the values of FPsa1 and FPsa2 calculated with a reference FPs value, said reference FPs value being between 4.00 and 4.6 (mental process and/or CMOHA) wherein
a FPsa1 value between 4.00 and 4.6 and a FPsa2 value greater than 18 are indicative of a subject with class I Chronic Heart Failure (CHF) (NYHA classification) (mathematical concept, mental process and/or CMOHA);
a FPsa1 value between 4.61 and 5.49 and a FPsa2 value less than 18 are indicative of a subject with class II chronic heart failure (CHF) (NYHA classification) (mathematical concept, mental process and/or CMOHA);
a FPsa1 value greater than or equal to 5.5 and a FPsa2 value less than or equal to 8.5 are indicative of a subject with class III chronic heart failure (CHF) (NYHA classification) (mathematical concept, mental process and/or CMOHA);
a FPsa1 value less than 2.4 is indicative of a subject with class IV chronic heart failure (CHF) (NYHA classification) (mathematical concept, mental process and/or CMOHA),
wherein [the] method is optionally implemented by computer (mathematical concept, mental process and/or CMOHA).
Regarding claims 11 and 12, representative claim 11 recites an abstract idea identified in bold as a simplified method of detecting early the onset of cardio-pulmonary diseases (mental process and/or CMOHA), comprising the following steps:
providing a baseline physiological parameter of a negative COVID-19 subject at rest, wherein said parameter was measured at a time t1, said physiological parameter being the exhaled CO2 volume per minute (VCO2); (mathematical concept, mental process and/or CMOHA) (This step (I) is overlapped by step (a) of claim 1. However, while step (a) of claim 1 recites “providing a set of physiological parameters of said subject at rest, wherein said parameters have been measured at a time t1,” step (I) of claim 9 recites “providing a baseline physiological parameter of a negative COVID-19 subject at rest”. Step (I) is referenced in at least steps (II) and (V) below.)
from the baseline VCO2 value, obtaining FPst1 with the following algorithm (F) (mathematical concept, mental process and/or CMOHA) :
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providing one or more VCO2 values of said subject at rest, said one or more values being obtained at times tn subsequent to time t1; (This step (III) is overlapped by step (c) of claim 1. However, while step (c) of claim 1 recites “wherein said parameters have been measured at a time t2 subsequent to t1 by 24 hours or less,” step (III) recites “said one or more values being obtained at times tn subsequent to time t1.” Step (III) is referenced in at least steps (IV) and (V) below.)
from one or more VCO2 values of step III), obtaining respective FPstn with algorithm (F) (mathematical concept, mental process and/or CMOHA):
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(mathematical concept, mental process and/or CMOHA)
comparing the one or more FPstn values according to steps III) and IV) with the respective baseline value of step I) and II) (mental process and/or CMOHA) and calculating the ratio FPstn/FPst1 (mathematical concept, mental process and/or CMOHA), wherein:
if there is the condition in which FPstn/FPst1 is greater than 1 and/or tends to increase over time from a time t2 subsequent to t1 to t-nth times subsequent to t2, then the subject has a probability of suffering from CHF (mathematical concept, mental process and/or CMOHA);
if there is the condition in which FPst2/FPst1 is less than 1 and/or tends to decrease over time from a time t2 subsequent to t1 to t-nth times subsequent to t2, then the subject has a probability of suffering from pulmonary hypertension not yet diagnosed (mathematical concept, mental process and/or CMOHA); and
if there is the condition in which the ratio FPst1/FPst1 abruptly decreases from a time t2 subsequent to t1 to t-nth times subsequent to t2 by 24 hours or less and the ratio FPst2/FPst1 is less than 0.77, then the subject has a probability of suffering from pulmonary thromboembolism (mathematical concept, mental process and/or CMOHA).
Claim 12 further recites the abstract idea identified in bold as a method of monitoring the pulmonary parameters of a subject practicing high-altitude climbing or scuba diving with a tank (mathematical concept, mental process and/or CMOHA), comprising the following steps:
providing a baseline physiological parameter of a subject at rest, wherein said parameter was measured at a time t1, said physiological parameter being the exhaled CO2 volume per minute (VCO2); (This step (I) is overlapped by step (a) of claim 1 and step (I) of claim 11. This step (I) is referenced in at least step (V) below.)
from the baseline VCO2 value, obtaining FPst1 with the following algorithm (F) (mathematical concept, mental process and/or CMOHA) (This step (II) is overlapped by step (II) of claim 11 and referenced by at least step (V) below.):
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providing one or more VCO2 values of said subject at rest, said one or more values being obtained at times tn subsequent to time t1;
from one or more VCO2 values of step III), obtaining respective FPstn with algorithm (F) (mathematical concept, mental process and/or CMOHA) (This step (IV) is overlapped by step (IV) of claim 11.):
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(mathematical concept, mental process and/or CMOHA) (This step (IV) is overlapped by step (IV) of claim 11.) and
comparing the one or more FPstn values according to steps III) and IV) with the respective baseline value of step I) and II) (mental process and/or CMOHA) and calculating the ratio FPstn/FPst1 (mathematical concept, mental process and/or CMOHA), wherein: if there is the condition in which the FPstn value compared to the baseline FPst1 decreased by 1 unit and the ratio FPstn/FPst1 is between 0.75 and 0.80, then the subject has developed a risk of acute cardio-pulmonary disease (mathematical concept, mental process and/or CMOHA).
Mathematical Concept:
The limitations of “calculating (or obtaining) the pulmonary blood flow (FPs)” in claims 1, 3, and 9-12, “calculating the ratio FPst2/Qtt2” in claim 1, “if the ratio FPst1/Qtt1 calculated in step b) is substantially equal to the ratio FPst2/Qtt2 calculated in step d) and is equal to a reference value, said reference value being between 0.97 and 0.985, and if FPst1 is substantially equal to FPst2, and therefore the ratio FPst2/FPst1 is approximately equal to 1, comparing the calculated FPs value with a reference FPs value, said reference FPs value being between 4.00 and 4.6” in claim 1, “a FPs/Qt value between 0.97 and 0.985 and a FPs value between 4.00 and 4.6 is indicative of a normal value or of a subject with class I chronic heart failure (CHF) (classification NYHA)” in claim 1, “a FPs/Qt value between 0.90 and 0.977 and a FPs value between more than 4.6 and 5.49 is indicative of a value of a subject with class II CHF (NYHA classification)” in claim 1, “a FPs/Qt value less than 0.90 and a FPs value greater than or equal to about 5.5 is indicative of a value of a subject with class Ill CHF (NYHA classification)” in claim 1, “a FPs/Qt value between 0.82 and 0.9 and a FPs value between 4 and 4.6 is indicative of class I pulmonary hypertension (PH) (WHO/NYHA classification)” in claim 1, “a FPs/Qt value between 0.60 and 0.81 and a FPs value between 3.6 and 3.99 is indicative of class II pulmonary hypertension (PH) (WHO/NYHA classification)” in claim 1, “a FPs/Qt value between 0.40 and 0.59 and a FPs value between 2.4 and 3.599 is indicative of class III pulmonary hypertension (PH) (WHO/NYHA classification)” in claim 1, “a FPs/Qt value between 0.65 and 0.85 and a FPs value of less than 2.4 is indicative of class IV pulmonary hypertension (PH) (WHO/NYHA classification) and/or class IV CHF (NYHA classification)” in claim 1, “if FPst1 is substantially greater than FPst2 so that the ratio FPst2/FPst1 is less than 0.85 and FPSt1/Qtt1 is greater than FPst2/Qtt2 and the delta thereof is between 0.585 and 0.085 and if the subject does not suffer from altitude sickness and/or high-altitude pulmonary edema (HAPE) caused by high-altitude hypoxia or does not suffer from air embolism from scuba diving with tanks and has not taken vasoconstrictive drugs, such as acetazolamide, a FPst2 value substantially less than 4.00 is indicative of suspected pulmonary thromboembolism” in claim 1, “a FPsa1 value between 4.00 and 4.6 and a FPsa2 value greater than 18 are indicative of a subject with class I Chronic Heart Failure (CHF) (NYHA classification)” in claim 3, “a FPsa1 value between 4.61 and 5.49 and a FPsa2 value less than 18 are indicative of a subject with class II chronic heart failure (CHF) (NYHA classification)” in claim 3, “a FPsa1 value greater than or equal to 5.5 and a FPsa2 value less than or equal to 8.5 are indicative of a subject with class III chronic heart failure (CHF) (NYHA classification)” in claim 3, “a FPsa1 value less than 2.4 is indicative of a subject with class IV chronic heart failure (CHF) (NYHA classification)” in claim 3, “calculating [a max] ratio,… wherein the subject has reached the maximum effort if [the max ratio
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] is ≤ 5.86” in claim 9, “if Qt is greater than FPs, the Qt measurement is correct” in claim 10, “if Qt is less than FPs, the Qt measurement is incorrect (underestimated)” in claim 10, “calculating the ratio FPstn/FPst1” in claims 11 and 12, “if there is the condition in which FPstn/FPst1 is greater than 1 and/or tends to increase over time from a time t2 subsequent to t1 to t-nth times subsequent to t2, then the subject has a probability of suffering from CHF” in claim 11, “if there is the condition in which FPst2/FPst1 is less than 1 and/or tends to decrease over time from a time t2 subsequent to t1 to t-nth times subsequent to t2, then the subject has a probability of suffering from pulmonary hypertension not yet diagnosed” in claim 11, “if there is the condition in which the ratio FPst1/FPst1 abruptly decreases from a time t2 subsequent to t1 to t-nth times subsequent to t2 by 24 hours or less and the ratio FPst2/FPst1 is less than 0.77, then the subject has a probability of suffering from pulmonary thromboembolism” in claim 11, “if there is the condition in which FPstn/FPst1 is greater than 1 and/or tends to increase over time from a time t2 subsequent to t1 to t-nth times subsequent to t2, then the subject has a probability of suffering from CHF” in claim 12, “if there is the condition in which FPst2/FPst1 is less than 1 and/or tends to decrease over time from a time t2 subsequent to t1 to t-nth times subsequent to t2, then the subject has a probability of suffering from pulmonary hypertension not yet diagnosed” in claim 12, and “if there is the condition in which the ratio FPst1/FPst1 abruptly decreases from a time t2 subsequent to t1 to t-nth times subsequent to t2 by 24 hours or less and the ratio FPst2/FPst1 is less than 0.77, then the subject has a probability of suffering from pulmonary thromboembolism” in claim 12 define mathematical relationships between variables or numbers and/or recite numerical formulas or equations. The limitations amount to generating data by taking existing information, manipulating the data using mathematical calculations, and organizing this information into a new form. Thus, claims 1, 3, and 9-12 recite an abstract idea falling in the "mathematical concept" grouping. See MPEP 2106.04(a)(2)(I).
Mental Process:
The limitations in bold above for claims 1, 3, and 9-12, in addition to the limitations of “comparing the Qt value with the FPs value” in claim 10, “comparing the values of FPsa1 and FPsa2 calculated with a reference FPs value, said reference FPs value being between 4.00 and 4.6” in claim 3, “comparing the one or more FPstn values according to steps III) and IV) with the respective baseline value of step I) and II)” in claims 11 and 12 may be practically performed in the human mind using observation, evaluation, judgment, and opinion. Furthermore, the limitations in combination with computer components (i.e., implemented by [a] computer) still amount to an abstract idea because no distinction should be made between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). With the exception of generic computer-implemented steps, there is nothing in claims 1, 3, and 9-12 themselves that foreclose them from being performed by a human, mentally or with tools such as pen and paper. The limitations are directed to mental processes of parsing and comparing data, because the steps were recited at a high level of generality and merely used computers as a tool to perform conventional computer processes. See MPEP 2106.04(a)(2)(III)(C)(3). Thus, this activity is an abstract idea in the "mental process" grouping.
CMOHA:
The limitations of claims 1, 3, and 9-12 (i.e., identified in bold in the Mental Processes section above) amount to an act of managing personal behavior (i.e., rules and instructions governing mental processes to be followed by a human). See MPEP 2106.04(a)(2)(II)). Furthermore, these limitations in combination with a computer component (i.e., implemented by [a] computer) still amount to an abstract idea because no distinction should be made between claims that recite mental processes performed by humans (i.e., as required by rules or instructions to manage personal behavior) and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). Thus, this activity is an abstract idea in the "CMOHA" grouping.
Accordingly, claims 1, 3, and 9-12 are directed to judicial exceptions under Step 2A, Prong One.
Dependent claims 2, 4-8, and 14-17 present additional information in tandem with further details regarding elements from an associated one of independent claims 1 and 3 and are therefore directed to one or more abstract ideas for similar reasons as given Under Step 2A, Prong One above. Claims 2, 4-8, and 14-17 are directed to one or more judicial exceptions (i.e., abstract idea exceptions) under Step 2A, Prong One of the full eligibility analysis as follows:
Mathematical Concept:
Claims 2, 4, 6-8, and 14-17 recite the limitations of “the functional PH classification, which is based on the WHO/NYHA classification, based on the symptoms associated with physical activity performed by the subject, is shown in the following table” in claim 2, “the NYHA functional classification for CHF based on the symptomatology associated with physical activity performed by the subject is shown in the following table” in claim 4, the maximum exercise power delivered by the tested subjects is shown in the following table:
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in claim 5, “calculating the ratio:
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and wherein the parameters [HCO3 −]v, [HCO3 −]a, PCO2v, PCO2a and FPs are obtained from a subject at rest” in claim 6, “a value greater than 12.3 and preferably less than 12.5 indicates class I (NYHA classification)” in claim 6, “a value between 11 and 12.3 indicates class II (NYHA classification)” in claim 6, “a value less than 11 and greater than 9 indicates class III (NYHA classification)” in claim 6, “a value between 8 and 9 indicates class IV (NYHA classification)” in claim 6, “FPs ≥ 5.5 L/min calculated with the set of parameters of step a1)” in claim 7, “FPs < 8.5 L/min calculated with the set of parameters of step a2)” in claim 7, “ΦH+FPs)>18.8 nmol/min calculated with the set of parameters of step a1) with the following equation: ΦH(FPs) +=([H+]v−[H+]a)×FPs” in claim 7, “ΦH+(FPs)<154 nmol/min calculated with the set of parameters of step a2) with the following equation: ΦH(FPs) +=([H+]v−[H+]a)×FPs” in claim 7, “
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less than 11 and greater than 9 calculated with the set of parameters of step a1)” in claim 7, “
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calculated with the set of parameters of step a1)” in claim 7, “FPs/Qt<0.90 calculated with the set of parameters of step a1)” in claim 7, “II) calculating the pulmonary blood flow (FPst1) from said parameter of step I) according to the following algorithm:
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in claim 8, “IV) calculating the pulmonary blood flow (FPst2) from said parameter of step III) according to the algorithm F of step II)” in claim 8, “V) if FPst1 is substantially equal to FPst2 and therefore the ratio FPst2/FPst1 is approximately equal to 1, comparing the calculated FPs value with a reference FPs value, said reference FPs value being between 3.3 and 4.35 and a VCO2/kg body weight value between 4.37 and 6.11” in claim 8, “a FPs value between 3.3 and 4.35 and a VCO2/kg body weight value between 4.37 and 6.11 are indicative of a normal value, for subjects aged between 10 and 50, or of a subject (max 50 years) with class I chronic heart failure (CHF) (NYHA classification)” in claim 8, “values less than 3.3 or greater than 4.35, obtained from algorithm F and a VCO2/kg body weight value less than 4.37 or greater than 6.11, for the indicated age group, are potentially indicative of a cardiac and/or pulmonary or genetic disease (e.g., cystic fibrosis) and require confirmation by calculating the FPs with the algorithms A and/or B described in claim 1, step b) and in claim 3, step b1)” in claim 8, “VI) if FPst1 is substantially greater than FPst2 so that the ratio FPst2/FPst1 is less than 0.77 and if the subject does not suffer from altitude sickness and/or high-altitude pulmonary edema (HAPE) caused by high-altitude hypoxia or does not suffer from air embolism from diving with tanks and has not taken vasoconstrictive drugs, such as acetazolamide, a FPst2 value substantially lower with respect to the value of FPst1 thereof, preferably about 1 L/min, is indicative of suspected pulmonary thromboembolism” in claim 8, “media or carrier selected from magnetic tapes, magnetic disks, optical disks, magneto-optical disks, ROMs, PROMs, VCDs, DVDs or other computer-readable means, comprising a software implementing the method according to claim 1” in claim 14, “the NYHA functional classification for CHF based on the symptomatology associated with physical activity performed by the subject is shown in the following table” in claim 15, “calculating the ratio:
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and wherein the parameters [HCO3 −]v, [HCO3 −]a, PCO2v, PCO2a and FPs are obtained from a subject at rest” in claim 16, “a value greater than 12.3 and preferably less than 12.5 indicates class I (NYHA classification)” in claim 16, “a value between 11 and 12.3 indicates class II (NYHA classification)” in claim 16, “a value less than 11 and greater than 9 indicates class III (NYHA classification)” in claim 16, “a value between 8 and 9 indicates class IV (NYHA classification)” in claim 16, “FPs ≥ 5.5 L/min calculated with the set of parameters of step a1)” in claim 17, “FPs < 8.5 L/min calculated with the set of parameters of step a2)” in claim 17, “ΦH+ (FPs) > 18.8 nmol/min calculated with the set of parameters of step a1) with the following equation:
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in claim 17, ΦH+(FPs)<154 nmol/min calculated with the set of parameters of step a2) with the following equation:
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in claim 17, “
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less than 11 and greater than 9 calculated with the set of parameters of step a1)” in claim 17,
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calculated with the set of parameters of step a1) in claim 17, and “FPs/Qt<0.90 calculated with the set of parameters of step a1)” in claim 17 define mathematical relationships between variables or numbers and/or recite numerical formulas or equations (i.e., to define the calculated FPs/Qt values and the calculated FPs values, each associated with the NYHA classification). These limitations amount to generating data by taking existing information, manipulating the data using mathematical calculations, and organizing this information into a new form. Thus, claims 2, 4-8, and 14-17 recite an abstract idea falling in the "mathematical concept" grouping. See MPEP 2106.04(a)(2)(I).
Mental Process:
The limitations in bold above for claims 2, 4-8, and 14-17, in addition to the limitations of “h) assigning the value calculated according to step g) to an NYHA class for the disease CHF” in claim 6, “i) assigning a subject suffering from CHF to class III (NYHA classification)” in claims 7 and 17, “comparing the calculated FPs value with a reference FPs value, said reference FPs value being between 3.3 and 4.35 and a VCO2/kg body weight value between 4.37 and 6.11” in claim 8, “a software implementing the method according to claim 1” in claim 14, “the NYHA functional classification for CHF based on the symptomatology associated with physical activity performed by the subject is shown in the following table:” in claim 15, and “h) assigning the value calculated according to step g) to an NYHA class for the disease CHF” in claim 16 may be practically performed in the human mind using observation, evaluation, judgment, and opinion. Furthermore, the limitations in combination with computer components (i.e., implemented by [a] computer) still amount to an abstract idea because no distinction should be made between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). With the exception of generic computer-implemented steps, there is nothing in claims 2, 4-8, and 14-17 themselves that foreclose them from being performed by a human, mentally or with tools such as pen and paper. The limitations are directed to mental processes of parsing and comparing data, because the steps were recited at a high level of generality and merely used computers as a tool to perform conventional computer processes. See MPEP 2106.04(a)(2)(III)(C)(3). Thus, this activity is an abstract idea in the "mental process" grouping.
CMOHA:
The limitations of claims 2, 4-8, and 14-17 (i.e., identified in bold in the Mental Processes section above) amount to an act of managing personal behavior (i.e., rules and instructions governing mental processes to be followed by a human). See MPEP 2106.04(a)(2)(II)). Furthermore, these limitations in combination with a computer component (i.e., implemented by [a] computer) still amount to an abstract idea because no distinction should be made between claims that recite mental processes performed by humans (i.e., as required by rules or instructions to manage personal behavior) and claims that recite mental processes performed on a computer. See MPEP 2106.04(a)(2)(III). Thus, this activity is an abstract idea in the "CMOHA" grouping.
Accordingly, claims 2, 4-8, and 14-17 are directed to judicial exceptions under Step 2A, Prong One.
Eligibility Step 2A, Prong Two:
Under Step 2A, Prong Two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the claims recite any additional limitations individually or in combination that integrate a judicial exception (i.e., the identified abstract ideas) into a practical application. After evaluation, it has been determined that claims 1-12 and 14-17 do not recite any additional elements individually or in combination that integrate the abstract ideas into a practical application.
A number of considerations provided in MPEP 2106.04(d)(2), MPEP 2106.05(a) through (c), and MPEP 2106.05(e) through (h) are relevant to determining whether any additional elements individually or in combination integrate the judicial exception (i.e., the abstract ideas defined as mathematical concepts, mental processes, and/or CMOHAs) into a practical application. See MPEP 2106.04(d). These considerations require an evaluation of the claims to determine whether the additional limitations individually or in combination:
effect a particular treatment or prophylaxis for a disease or medical condition under MPEP 2106.04(d)(2);
reflect an improvement to the functioning of a computer, or an improvements to any other technology or technical field under MPEP 2106.05(a);
implement the judicial exception with, or using the judicial exception in connection with, a particular machine or manufacture that is integral to the claim under MPEP 2106.05(b);
effect a transformation or reduction of a particular article to a different state or thing under MPEP 2106.05(c);
apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition under MPEP 2106.05(e);
are mere instructions to implement an abstract idea on a computer under MPEP 2106.05(f);
amount to no more than a recitation of insignificant extra-solution activity to the judicial exception under MPEP 2106.05(g); and
apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment under MPEP 2106.05(h), such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Independent claims 1, 3, and 9-12 recite additional limitations beyond the judicial exceptions. Representative claim 1 recites the additional limitations identified in bold as a method for diagnosing a cardiac or pulmonary disease (mathematical concept, mental process and/or CMOHA) comprising the following steps:
providing a set of physiological parameters of a subject at rest, wherein said parameters have been measured at a time t1, said physiological parameters being selected from exhaled CO2 volume per minute (VCO2), cardiac output (Qt), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a);
calculating the pulmonary blood flow (FPst1) from said set of parameters of step a) according to one or both of the following algorithms:
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and calculating the ratio FPst1/Qtt1:
providing a second set of physiological parameters of a subject at rest, wherein said parameters have been measured at a time t2 subsequent to t1 by 24 hours or less, said physiological parameters being selected from exhaled CO2 volume per minute (VCO2), cardiac output (Qt), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a);
calculating the pulmonary blood flow (FPst2) from said set of parameters of step c) according to one or both algorithms of step b) and calculating the ratio FPst2/Qtt2;
if the ratio FPst1/Qtt1 calculated in step b) is substantially equal to the ratio FPst2/Qtt2 calculated in step d) and is equal to a reference value, said reference value being between 0.97 and 0.985, and if FPst1 is substantially equal to FPst2, and therefore the ratio FPst2/FPst1 is approximately equal to 1, comparing the calculated FPs value with a reference FPs value, said reference FPs value being between 4.00 and 4.6, wherein;
a FPs/Qt value between 0.97 and 0.985 and a FPs value between 4.00 and 4.6 is indicative of a normal value or of a subject with class I chronic heart failure (CHF) (classification NYHA);
a FPs/Qt value between 0.90 and 0.977 and a FPs value between more than 4.6 and 5.49 is indicative of a value of a subject with class II CHF (NYHA classification);
a FPs/Qt value less than 0.90 and a FPs value greater than or equal to about 5.5 is indicative of a value of a subject with class Ill CHF (NYHA classification);
a FPs/Qt value between 0.82 and 0.9 and a FPs value between 4 and 4.6 is indicative of class I pulmonary hypertension (PH) (WHO/NYHA classification);
a FPs/Qt value between 0.60 and 0.81 and a FPs value between 3.6 and 3.99 is indicative of class II pulmonary hypertension (PH) (WHO/NYHA classification);
a FPs/Qt value between 0.40 and 0.59 and a FPs value between 2.4 and 3.599 is indicative of class III pulmonary hypertension (PH) (WHO/NYHA classification); and
a FPs/Qt value between 0.65 and 0.85 and a FPs value of less than 2.4 is indicative of class IV pulmonary hypertension (PH) (WHO/NYHA classification) and/or class IV CHF (NYHA classification);
if FPst1 is substantially greater than FPst2 so that the ratio FPst2/FPst1 is less than 0.85 and FPSt1/Qtt1 is greater than FPst2/Qtt2 and the delta thereof is between 0.585 and 0.085 and if the subject does not suffer from altitude sickness and/or high-altitude pulmonary edema (HAPE) caused by high-altitude hypoxia or does not suffer from air embolism from scuba diving with tanks and has not taken vasoconstrictive drugs, such as acetazolamide, a FPst2 value substantially less than 4.00 is indicative of suspected pulmonary thromboembolism,
wherein [the] method is optionally implemented by [a] computer.
Claim 3 further recites the additional limitations identified in bold as a method of diagnosing CHF, comprising the following steps:
a2. providing a set of physiological parameters of said subject under maximum effort, said physiological parameters being chosen from exhaled CO2 volume per minute (VCO2), cardiac output (Qt), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a); (This step (a2) is overlapped by step (c) of claim 1. However, while step (c) of claim 1 recites “providing a second set of physiological parameters of a subject at rest, wherein said parameters have been measured at a time t2 subsequent to t1 by 24 hours or less,” step (a2) recites “providing a set of physiological parameters of said subject under maximum effort.”)
Claim 9 further recites the additional limitations identified in bold as a method for evaluating a subject's achievement of a maximum effort condition during an exercise, in particular for a heart examination under effort or the like, the method comprising the following steps:
providing a set of physiological parameters of said subject under effort, said physiological parameters being chosen from exhaled CO2 volume per minute (VCO2), CO2 partial pressure in venous blood (PCO2v), CO2 partial pressure in arterial blood (PCO2a), bicarbonate anion concentration in venous blood ([HCO3 −]v), and bicarbonate anion concentration in arterial blood ([HCO3 −]a; and (This step (i) is overlapped by step (a) of claim 1. However, while step (a) of claim 1 recites providing the set of physiological parameters of said subject at rest, step (i) recites providing the set of physiological parameters of said subject under effort.)
Claim 11 further recites the additional limitations identified in bold as a simplified method of detecting early the onset of cardio-pulmonary diseases, comprising the following steps:
providing a baseline physiological parameter of a negative COVID-19 subject at rest, wherein said parameter was measured at a time t1, said physiological parameter being the exhaled CO2 volume per minute (VCO2); (This step (I) is overlapped by step (a) of claim 1. However, while step (a) of claim 1 recit