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 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 1-7 are rejected under 35 U.S.C. 101 because of the following analysis:
Step 1: Do the claims recite one of the statutory categories of matter (i.e. method, apparatus, etc.)? YES, claims 1-6 recite an apparatus and claim 7 recites a method.
Step 2A Prong 1: Is there an abstract idea involved? YES, the claim language recites calculating a hemodynamic parameter and a respiratory variation of the hemodynamic parameter, calculating a heart rate in one respiration, and calculate the respiratory variation in the set predetermined period. These limitations, as drafted, are processes that, under its broadest reasonable interpretation, covers performance of the limitation in mind or by a person using a pen and paper.
Step 2a Prong 2: Do the claims recite additional elements that integrate the exception into a practical application? NO, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The claims recite a display, heart rate acquisition unit, respiration rate acquisition unit, a processor and display controller. The elements amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (see MPEP 2106.04(d) and 2106.05(f)). Accordingly, each of the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Furthermore, the heart rate and respiration rate acquisition units amount to nothing more than necessary data gathering, which is an extrasolution activity (see MPEP 2106.05(g)).
Step 2B: Do the additional elements amount to “Significantly More” than the judicial exception? The emphasized elements cited above do not amount to significantly more than the judicial exception because these limitations are simply appending well-understood, routine and conventional activities previously known in 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 in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’I, 110 USPQ2d 1976 (2014)).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) 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, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process. 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)).
The respective dependent claims recite the same abstract idea as the independent claims and do not amount to significantly more than the above-judicial exception (the abstract idea). Therefore, they are also rejected.
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.
Claims 1-7 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.
Regarding claims 1 and 7, the claims recite “a hemodynamic parameter” and “a plurality of hemodynamic parameters” without proper antecedent basis. Is hemodynamic parameter singular or plural?
Regarding claim 2, “the number of respiratory cycles” lacks antecedent basis. And “a respiratory cycle” is indefinite since there are references to “one or more respiratory cycles” and “number of respiratory cycles”. Which respiratory cycle is being referenced? Further clarification is required.
Regarding claim 4, “the number of pieces of data…” lacks antecedent basis.
Regarding claim 5, “the number of pieces of data…” and “respiratory cycles being included…” lack antecedent basis.
Regarding claim 6, “the number of pieces of data…” lacks antecedent basis.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien (US 2009/0131805 A1) in view of Hatib (US 2005/0187481 A1), further in view of De Backer (“Influence of Respiratory Rate on Stroke Volume Variation in Mechanically Ventilated Patient”, 2009).
Regarding claims 1 and 7, discloses A physiological information display apparatus comprising: a heart rate acquisition unit configured to acquire a heart rate of a subject (eg. Para. 10, heart rate data collected from arterial catheterization); a respiration rate acquisition unit configured to acquire a respiration rate of the subject (e.g Para. 10, can also be collected from arterial catheterization, Para. 129-130); a hemodynamics calculation unit configured to calculate: a hemodynamic parameter of the subject (eg. Para. 13, 34, 50-54, 68, 78, 85, 87-90); and a respiratory variation of the hemodynamic parameter (Eg. Para. 13, 34, 50-54, 68, 78, 85, 87-90), based on a plurality of the hemodynamic parameters calculated in a predetermined period (eg. Para. 10, 13, 34, 50-54, 68, 78, 85, 87-90, 119-126); and a display controller configured to output the respiratory variation to a display (eg. Fig. 1-2, 4-6, and associated paragraphs and Para. 34, 50, 78, 85, 90-102, 119-126), but does not explicitly disclose wherein the hemodynamics calculation unit is further configured to calculate a heart rate in one respiration, using the heart rate and the respiration rate, the heart rate in one respiration being a heart rate included in one respiratory cycle, the display controller is further configured to output, to the display, a setting screen for setting a length of the predetermined period, the setting screen configured to display the heart rate in one respiration, and the hemodynamics calculation unit is configured to: acquire setting information indicating contents set on the setting screen; set the length of the predetermined period based on the acquired setting information; and calculate the respiratory variation in the set predetermined period.
Hatib teaches a monitoring device that determines SVV as a function of standard deviation values over one respiratory cycle (eg. Abstract, claim 1, Para. 22-33, 69, 76, 78-84), a user settable computation interval via a GUI input device (eg. Para. 108), and acquiring setting information indicating contents on the setting screen, set the length of the predetermined period based on the acquired setting information, and calculate the respiratory variation in the set predetermined period (eg. Para. 108, user changes computational interval, then corresponding information must be made available to the estimation software component 370 so that it can direct the SVV estimation module to select the required input values when computing SVV).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of O’Brien with the user settable computation interval as taught by Hatib to provide the predictable result of giving more flexibility to O’Brien’s respiratory cycle referenced variation using a known method of changing computation intervals for computing SVV values.
De Backer teaches calculating heart rate in one respiration, using the heart rate and respiration rate, the heart rate in one respiration being a heart rate included in one respiratory cycle (eg. Background, Pg. 1092-1093, 1096-1097, Fig. 2 HR/RR metric is essentially heartbeats per respiratory cycle).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of O’Brien and Hatib with the HR/RR for SVV evaluation as taught by De Backer since RR affects the calculation of SVV and fluid responsiveness (eg. De Backer, Pg. 1092-1093).
Regarding claim 2, the combined invention of O’Brien, Hatib, and De Backer discloses wherein the length of the predetermined period is a length of one or more respiratory cycles, the display controller is configured to cause the display to display the setting screen in which the number of respiratory cycles included in the predetermined period is configured to be set, and one or more processors is configured to set the length of the predetermined period, based on a respiratory cycle and the number of respiratory cycles, the respiratory cycle being detected based on at least one of a start timing and an end timing of respiration of the subject, the number of respiratory cycles being set on the setting screen (eg. Hatib, Para. 30, 82).
Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien (US 2009/0131805 A1) in view of Hatib (US 2005/0187481 A1), further in view of De Backer (“Influence of Respiratory Rate on Stroke Volume Variation in Mechanically Ventilated Patient”, 2009).
Regarding claim 3, the combined invention of O’Brien, Hatib, and De Backer discloses the invention of claim 2, but does not disclose respiration rate acquisition unit is further configured to determine at least one of the start timing and the end timing of respiration of the subject, based on a detection result from a detection device, the detection device being configured to detect a concentration of carbon dioxide in expired air of the subject.
Colman teaches a CO2 sensor (eg. Para. 1-4, 45, 52, 54, 66-67, 70-71, 79-81, 87-88, 107-109, 114) and determining breaths defined by two consecutive exhalation phases (eg. Para. 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of O’Brien, Hatib, and De Backer with the CO2 sensor and respiratory cycle determination as taught by Colman to provide the predictable result of improving the accuracy of determining heart rate per respiration rate calculations by having more accurate detection of respiration cycles.
Regarding claim 4, the combined invention of O’Brien, Hatib, De Backer, and Coiman discloses the display controller is further configured to cause the display to display the setting screen in which automatic change of the length of the predetermined period is configured to be set, and the one or more processors is configured to set the predetermined period to be long, in a case where the automatic change of the length of the predetermined period is set on the setting screen and the number of pieces of data of the hemodynamic parameter calculated in the predetermined period is less than a threshold (eg. Colman, Para. 10, 47, 84, 106, 135).
Regarding claim 5, the combined invention of O’Brien, Hatib, De Backer, and Coiman discloses the length of the predetermined period is a length of one or more respiratory cycles, and in a case where the performs the automatic change of the length of the predetermined period, the one or more processors is configured to: increases the number of respiratory cycles included in the predetermined period until the number of pieces of data becomes equal to or greater than the threshold; and set the length of the predetermined period, based on a respiratory cycle and the number of respiratory cycles, the respiratory cycle being detected based on at least one of a start timing and an end timing of respiration of the subject, respiratory cycles being included in the predetermined period (eg. Colman, Para. 10, 47, 84, 106, 135 n+1 breath cycle extension until reliability value falls within threshold combined with Hatib’s respiratory cycle window, Para. 28-30, 69, 76-84, 94, claim 4). One of ordinary skill would have been able to use an identical adaptive window to a breath count and extending the count as necessary for a reliable threshold.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien (US 2009/0131805 A1) in view of Hatib (US 2005/0187481 A1), further in view of De Backer (“Influence of Respiratory Rate on Stroke Volume Variation in Mechanically Ventilated Patient”, 2009), further in view of Sugo (US 2011/0060531 A1).
Regarding claim 6, the combined invention of O’Brien, Hatib, and De Backer discloses the invention of claim 1, but does not disclose one or more processors is configured not to calculate the respiratory variation, in a case where the number of pieces of data of the hemodynamic parameter calculated in the predetermined period is less than a threshold.
Sugo teaches a blood volume measuring apparatus that counts SVV data and excludes outliers by value and deviation from the median (eg. Abstract, Para. 31, 77-79, Fig. 2-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the invention of O’Brien, Hatib, and De Backer with the outlier exclusion as taught by Sugo to provide the predictable result of suppressing unreliable outputs for lower sample sizes.
Conclusion
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/MICHAEL J LAU/Examiner, Art Unit 3796
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