DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 1 is under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
There is insufficient antecedent basis for the following limitations in the claim:
Claim 1, line 1, “the likelihood of the presence”
Claim 1, line 3, “providing the CO2 measurement data concerning the end-tidal partial pressure”
Claim 1, line 6, “the value of the Sokolow-Lyon index, the value of the S wave in V5, the value”
Claim 1, line 7, “of the R wave in V4 and the value of the angle of the QRS axis from the ECG”
Claim 1, line 10, “determining a score value”, however, it is unclear if the score value S is the same as “a score value (S)” in line 1 or not. For the purpose of examination, it is interpreted as the same.
Claim 1, lines 18-19 recites “if PetCO2 is greater than or equal to G1, S is equal to 1 if PetCO2 is less than G1, the method is continued in step lllb” However, it is unclear if the PetCO2 is the same as line 17 PetCO2 or not. For the purpose of examination, it is interpreted as the same.
Claim 1, lines 22-24 recites “if Sokolow-Lyon index is greater than or equal to G2, S is equal to 1, if Sokolow-Lyon index < G2, the method is continued in step Ille”. However, it is unclear if it is referring to the same Sokolow-Lyon index in line 20. For the purpose of examination, it is interpreted as the same.
Claim 1, lines 26-27 recites “if S wave in V5 is greater than or equal to G3, S is equal to 1, if S wave in V5 < G3, the method is continued in step llld”. However, it is unclear if it is referring to the same S wave in line in line 25. For the purpose of examination, it is interpreted as the same.
Claim 1, lines 29-30 recites “if R wave in V2 is less than G4, S is equal to 1, if R wave in V2 is greater than or equal to G4, the method is”. However, it is unclear if it is referring to the same R wave in line in line 28. For the purpose of examination, it is interpreted as the same.
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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a “method”, which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04)
Prong one: Claim 1 recites abstract idea, as follows:
“…providing the CO2 measurement data concerning the end-tidal partial pressure of CO2 (PetCO2) of the person (P) over a period (t); II. providing ECG measurement data of the person (P) and determining at least the value of the Sokolow-Lyon index, the value of the S wave in V5, the value of the R wave in V4 and the value of the angle of the QRS axis from the ECG measurement data of said person (P) as dynamic clinical parameter (P1) over the same period (t) as in step I; and III. determining a score value (S) for the likelihood of the presence of a pulmonary hypertension in said person from the CO2 measurement data concerning the end- tidal partial pressure of CO2 (PetCO2) from step I and at least the ECG measurement data as dynamic clinical parameters (P1) from step II in the following substeps, where S equal to 0 means a high likelihood of a pulmonary hypertension (PH) and S equal to 1 means a low likelihood of a pulmonary hypertension (PH);a. comparing the PetCO2 from step I with a limit value G1,e if PetCO2 is greater than or equal to G1, S is equal to 1," if PetCO2 is less than G1, the method is continued in step IlIb, b. comparing the value of the Sokolow-Lyon index from step II with a limit value G2," if Sokolow-Lyon index is greater than or equal to G2, S is equal to 1," if Sokolow-Lyon index < G2, the method is continued in step IlIc, c. comparing the value of the S wave in V5 from step II with a limit value G3, " if S wave in V5 is greater than or equal to G3, S is equal to 1, " if S wave in V5 < G3, the method is continued in step Illd, d. comparing the value of the R wave in V4 from step II with a limit value G4, " if R wave in V2 is less than G4, S is equal to 1, " if R wave in V2 is greater than or equal to G4, the method is continued in step Ille, e. comparing the value of the angle of the QRS axis from step II with a limit value G5,e if angle of the QRS axis is less than G5, S is equal to 1, " if angle of the QRS axis is less than or equal to G5, S is equal to 0.”
Based on the broadest reasonable interpretation, providing CO2 measurement data, providing ECG measurement data, determining a score value S, comparing PetCO2, comparing Sokolow-Lyon index, comparing S wave, comparing R wave, comparing the angle value of the QRS axis can be done mentally with the aid of a pen and paper. A person can provide a CO2 measurement data and ECG measurement data by drawing the data on a pencil or writing down the measurement values and time in a table. A person can then compare the PetCO2, Sokolow-Lyon index, S wave, R wave, the angle value of the QRS axis, by observing the numerical value written on a paper, and determining if it is greater, less than, or equal to a limit.
Prong two: Claim 1 does not include any additional elements.
Therefore, Claim 1 is ineligible at step 2A, prong two.
Allowable Subject Matter
Claim 1 would be allowable if rewritten to overcome the 112 and 101 rejections.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record is US20180296126A1 (Anderson et. al), hereto referred as Anderson. Anderson teaches a method for determining score S for PH likelihood (Abstract, “Systems and methods for estimating a ventilatory threshold for a patient and estimating likelihood of pulmonary arterial hypertension are provided”);
Use of binary convention, as in S equal to 0 means a high likelihood of a pulmonary hypertension (PH) and S equal to 1 means a low likelihood of a pulmonary hypertension (PH) ([0159]-[0161], “If TotalScore<=1 then PAH Unlikely, IF TotalScore between 1 and 3 then Consider PAH, If TotalScore between 3 and 5 then PAH likely”)
Providing PetCO2 continuously over a period ([0006], “determining a score based upon end-tidal partial pressure of carbon dioxide (PetCO2) and minute ventilation/carbon dioxide production relationship (VE/VCO2) at the determined ventilatory threshold”; Fig. 2)
Comparing PetCO2 from step I with a limit value G1 ([0151]-[0154], “IF PetCO2atVT>=37 then PetCO2Score=0; If PetCO2aNT between 30 and 37 PetCO2Score=1; If PetCO2atVT between 20 and 30 PetCO2Score=2; Otherwise PetCO2Score=3.”)
However, Anderson does not teach determining at least the value of the Sokolow-Lyon index from ECG measurement data, comparing the value of the Sokolow-Lyon index from step II with a limit value G2, comparing the value of the S wave in V5 from step II with a limit value G3, comparing the value of the R wave in V4 from step II with a limit value G4, comparing the value of the angle of the QRS axis from step II with a limit value G5, along with other claimed steps or elements.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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