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 § 103
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, 3, 5, 8, 8, 9, 11, 13, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sugo (US 2011/0060531) in view of Chang (US 5385149).
Regarding claims 1 and 9, Sugo discloses a pulse wave analyzer and a method of its use comprising:
a controller (element 40) configured to:
acquire a pulse wave of the subject, the pulse wave comprising a plurality of continuous unit pulse waves (paragraph [0056]);
acquire an electrocardiogram of the subject (paragraph [0055]);
acquire respiration information of the subject for at least one respiratory period (paragraphs [0064]-[0069]);
determine a selection criterion range based on the electrocardiogram and also based on the respiration information (paragraph [0055], the ECG is used to provide reference point based on identification of R waves that are used to coordinate further analysis of pulse waves/stroke volume; paragraph [0071], the evaluation of pulse waves only takes place if the evaluation of respiration information also yields a “yes”);
select unit pulse waves that meet the selection criterion range (paragraphs [0072]-[0077]),
calculate a respiratory variation from the selected unit pulse waves (paragraph [0080]); and
display the calculated respiratory variation on a display (paragraphs [0030]-[0032]).
Sugo does not call for the analyzer to calculate, for each of the unit pulse waves that has an immediately preceding unit pulse wave, a ratio between an amplitude of the unit pulse wave and an amplitude of the immediately preceding unit pulse wave and to select unit pulse waves that have calculated ratios within the selection criterion range, and eliminate unit pulse waves that have calculated ratios outside the selection criterion range; Chang teaches a pulse wave analyzer comprising a processor and memory (column 2, lines 56-66) configured to acquire pulse waves of a subject (column 2, lines 53-60) and select a “unit pulse wave” by comparing amplitudes of a plurality of “unit pulse wave” with each other and eliminating “unit pulse wave” having a variation in amplitude relative to an immediately preceding pulse wave that is equal to or greater than a “selection criterion” (column 2, lines 30-44). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Sugo and used comparison of amplitudes of adjacent waves to select the “unit pulse wave”, as taught by Chang, in order to ensure that the wave having the ultimate level of the desired attribute is selected.
The Examiner notes that the claims as amended present two distinct options for the selection criterion range: (1) based on the pulse wave and also based on the respiration information where a size of the range is inversely related to a number of unit pulse waves per respiratory period, OR (2) based on the electrocardiogram and also based on the respiration information.
Regarding claims 3, 5, 11, and 13, Sugo further discloses that the controller is further configured:
to calculate a heart rate contained in one respiratory period detected from the electrocardiogram in a predetermined time period (paragraph [0055]), and a respiration rate detected from the respiration information in the predetermined time period (paragraph [0064]), and
to determine the selection criterion range based on the calculated heart rate (paragraph [0062] calls for calculation of esSV per figure 11, which uses heart rate; per paragraphs [0064]-[0067]) the measured variation is a function of the calculated esSV and the thresholds placed on it are also a function of the calculated esSV and thus a function of HR).
Regarding claims 8 and 16, Sugo further discloses that the controller is further configured to display a graph representing the pulse wave and a mark on the graph in the vicinity of a pulse pressure variation (PPV) value and a PPV trend of the pulse wave when a number of unit pulse waves not selected is equal to or higher than a given level (figure 9; the Examiner notes that “a mark” is any mark, any mark on the display is “in the vicinity of” trends thereon, and in the absence of any specificity as to a particular “number” the number could be zero such that the “mark” is always displayed).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Sugo and Chang, as applied above, and further in view of Sugo’544 (US 2014/0121544).
Sugo discloses the presence of an alarm (figure 1 and 8) but does not discuss its use. Sugo’544 discloses a similar pulse wave analyzer configured to use its alarm to notify a user of an “abnormal” value (paragraph [0075]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Sugo, as modified, and generated an alarm to notify a user of an abnormal respiratory variation, as taught by Sugo’544, because Sugo already discloses the presence of an alarm but not its use and notification of abnormal values allows intervention for adverse conditions.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record fails to anticipate or make obvious the invention of claim 7, including, inter-alia, a pulse wave analyzer configured to acquire a plurality of continuous unit pulse waves, an electrocardiogram, and respiration information; select a plurality of unit pulse waves by determining an amplitude of each of the unit pulse waves, calculating an average amplitude of the plurality of unit pulse waves and a standard deviation of the amplitudes of the unit pulse waves in a predetermined time period, and eliminating unit pulse waves having an amplitude that is equal to or less than a lower limit, or that is equal to or greater than an upper limit, wherein the lower limit and the upper limit define a range of amplitude values inclusive of the average amplitude, and are determined based on the standard deviation relative to the average amplitude; and calculate and display a respiratory variation from the selected unit pulse waves, in combination with all other limitations in the claim.
Sugo discloses a similar system, as discussed in previous Office Actions, but the Board of Appeals determined on 6 August 2025 that Sugo’s upper and lower limits are not based on standard deviation relative to an average amplitude.
The prior art of record fails to anticipate or make obvious the invention of claim 19, including, inter-alia, a pulse wave analyzer configured to acquire a plurality of continuous unit pulse waves, an electrocardiogram, and respiration information for at least one respiratory period; determine a ratio threshold based on the pulse wave or the electrocardiogram, and also based on the respiration information; calculate, for each of the unit pulse waves that has an immediately preceding unit pulse wave, a ratio between an amplitude of the unit pulse wave and an amplitude of the immediately preceding unit pulse wave; select unit pulse waves that have calculated ratios less than the determined ratio threshold, and eliminate unit pulse waves that have calculated ratios greater than or equal to the determined ratio threshold; and calculate and display a respiratory variation from the selected unit pulse waves, in combination with all other limitations in the claims.
Kitajima, applied in previous Office Actions, uses a ratio between amplitudes of adjacent pulse waves as a selection criteria, but does not use the selection criteria for eliminating unit pulse waves.
Response to Arguments
Applicant's arguments filed 25 February 2026 have been fully considered but they are not persuasive.
Regarding the art rejections, Applicant argues only that Sugo is cited as teaching the selection criterion range being selected using the “first alternative (pulse wave and respiratory information)” but does not teach the size of that selection range being inversely related to a number of unit pulse waves per respiratory period. Applicant’s attention is drawn to page 3 of the Office Action mailed 2 December 2025, reproduced in part here:
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This is also the text of the rejection presented above. Sugo clearly teaches the electrocardiogram as being involved in determining the selection criterion range, as noted in Applicant’s remarks despite Applicant somehow interpreting the clear description of “based on the electrocardiogram” and citing text describing use of an electrocardiogram as being an attempt to teach use of pulse waves - a different, alternative limitation. As Applicant’s argument is unrelated to the rejection of the claims, the assertion that Sugo fails to teach limitations which it is not relied upon to teach while not addressing the limitations that Sugo is cited as disclosing is unpersuasive in overcoming the rejection as a whole, and the claims remain rejected.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KAREN E TOTH/Examiner, Art Unit 3791