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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 12/23/25, amended claim(s) 1, 14, and 16 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Objections
Claim 1 is objected to because of the following informalities: “the maximum-minimum oscillation interval” (line 17) appears that it should be “the maximum-to-minimum oscillation interval.”
Claim 14 is objected to because of the following informalities: “the maximum-minimum oscillation interval” (line 17) appears that it should be “the maximum-to-minimum oscillation interval.”
Claim 16 is objected to because of the following informalities: “the maximum-minimum oscillation interval” (line 17) appears that it should be “the maximum-to-minimum oscillation interval.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 3-7, 10-14, and 16-23 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For claim 1, the claim language “wherein the maximum value is determined such than an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval” appears to be new matter. The examiner could not find these exact terms in the specification and, although the exact terms used in the claims do not need to be used in the specification, the examiner cannot find any corollaries either. Page 2, lines 5-7 of Applicant’s specification as originally filed mentions a “fraction,” but this fraction is “heuristically determined” and therefore not predetermined. Page 17, lines 1-8 also mention a “fraction,” but equation 7 is using this fraction to calculate a “duration” not a “maximum value” that limits a rate of change of inflation speed of a wearable cuff. Additionally, there is no mention that this fraction is predetermined. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
For claim 14, the claim language “wherein the maximum value is determined such than an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval” appears to be new matter. The examiner could not find these exact terms in the specification and, although the exact terms used in the claims do not need to be used in the specification, the examiner cannot find any corollaries either. Page 2, lines 5-7 of Applicant’s specification as originally filed mentions a “fraction,” but this fraction is “heuristically determined” and therefore not predetermined. Page 17, lines 1-8 also mention a “fraction,” but equation 7 is using this fraction to calculate a “duration” not a “maximum value” that limits a rate of change of inflation speed of a wearable cuff. Additionally, there is no mention that this fraction is predetermined. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
For claim 16, the claim language “wherein the maximum value is determined such than an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval” appears to be new matter. The examiner could not find these exact terms in the specification and, although the exact terms used in the claims do not need to be used in the specification, the examiner cannot find any corollaries either. Page 2, lines 5-7 of Applicant’s specification as originally filed mentions a “fraction,” but this fraction is “heuristically determined” and therefore not predetermined. Page 17, lines 1-8 also mention a “fraction,” but equation 7 is using this fraction to calculate a “duration” not a “maximum value” that limits a rate of change of inflation speed of a wearable cuff. Additionally, there is no mention that this fraction is predetermined. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
Dependent claim(s) 3-7, 10-13, and 17-23 fail to cure the deficiencies of independent claim(s) 1 and 16, thus claim(s) 1, 3-7, 10-14, and 16-23 is/are rejected under 35 U.S.C. 112(a).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-5, 10-11, 13-14, 16-19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0257116 to Kobayashi et al. (hereinafter “Kobayashi”) in view of U.S. Patent Application Publication No. 2014/0207009 to Sawanoi and U.S. Patent Application Publication No. 2016/0270673 to Aelen et al. (hereinafter “Aelen”).
For claim 1, Kobayashi discloses an apparatus for controlling a wearable cuff for use in measuring blood pressure (Abstract), the apparatus comprising:
a pump (51) (Fig. 1) (para [0054]) adapted to inflate the wearable cuff (20) (Fig. 1) (para [0050]) to pressurize a measurement site of a subject (para [0050]) and the apparatus is configured to:
initiate inflation of the wearable cuff at a first inflation speed (“initial target speed value,” para [0065]); and
change the first inflation speed during inflation of the wearable cuff (para [0065]), wherein the first inflation speed is changed at a rate that is limited to a maximum value by a limiter (“control signal,” from 115, para [0065]).
Kobayashi does not expressly disclose wherein the maximum value depends on one or more of: a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed; and an amplitude of a signal indicative of pressure oscillations detected in the wearable cuff during inflation of the wearable cuff at the first inflation speed.
However, Sawanoi teaches limiting an inflation speed based on a pulse rate of a subject (para [0154]) and that a pulse rate is acquired from the subject during an oscillometric method (i.e., inflation of a cuff, see para [0006]) (para [0052] and [0101]).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the maximum value depends on one or more of: a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed; and an amplitude of a signal indicative of pressure oscillations detected in the wearable cuff during inflation of the wearable cuff at the first inflation speed, in view of the teachings of Sawanoi, for the obvious advantage of being able to taken measurement of patients that even have a faint pulse (see para [0154] of Sawanoi).
Kobayashi and Sawanoi do not expressly disclose wherein the maximum value is determined such that an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval.
However, Aelen teaches wherein an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude (claim 5) (also see para [0028], [0100]-[0101], and [0137]), and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval (claim 5) (also see para [0028], [0100]-[0101], and [0137]).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the maximum value is determined such that an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval, in view of the teachings of Aelen, for the obvious advantage of avoiding tissue damage, pateitn discomfort, and measurement inaccuracy.
For claim 3, Kobayashi further discloses wherein the apparatus is configured to change the first inflation speed by: increasing the first inflation speed during inflation of the wearable cuff; or decreasing the first inflation speed during inflation of the wearable cuff (as can be seen in Fig. 7) (also see para [0065]).
For claim 4, Kobayashi further discloses wherein the first inflation speed is changed at a rate that is the maximum value or a rate that is less than the maximum value (as can be seen in Fig. 7) (also see para [0065]).
For claim 5, Kobayashi, as modified, further discloses wherein the first inflation speed is changed at a rate that is variable or a rate that is constant (as can be seen in Fig. 7) (also see para [0065]).
For claim 10, Kobayashi further discloses wherein the one or more characteristics of the apparatus comprise any one or more of: a size of the wearable cuff; and a resistance detected in the apparatus (“maximum output with no excess capacity,” para [0067]).
For claim 11, Kobayashi further discloses wherein the apparatus is further configured to: acquire a signal indicative of the pressure oscillations detected in the wearable cuff during inflation of the wearable cuff (para [0063] and [0065]) (also see para [0069], [0077], [0092], and [0143]); and determine a blood pressure value for the subject based on the acquired signal (para [0063] and [0065]) (also see para [0069], [0077], [0092], and [0143]).
For claim 13, Kobayashi discloses a system for use in measuring blood pressure (Abstract), the system comprising: the apparatus as claimed in claim 1 (see claim 1); and the wearable cuff (20) that is inflatable to pressurize the measurement site of the subject (para [0050]).
For claim 14, Kobayashi discloses a method of controlling a wearable cuff for use in measuring blood pressure (Abstract), wherein the wearable cuff (20) (Fig. 1) (para [0050]) is inflatable to pressurize a measurement site of a subject (para [0050]), the method comprising:
with a pump (51) (Fig. 1) (para [0054]), initiating inflation of the wearable cuff at a first inflation speed (20) (Fig. 1) (para [0050]); and
changing the first inflation speed during inflation of the wearable cuff by controlling the pump (para [0065]), wherein the first inflation speed is changed at a rate that is limited to a maximum value by a limiter (“control signal,” from 115, para [0065]).
Kobayashi does not expressly disclose wherein the maximum value depends on one or more of: a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed; and an amplitude of a signal indicative of pressure oscillations detected in the wearable cuff during inflation of the wearable cuff at the first inflation speed.
However, Sawanoi teaches limiting an inflation speed based on a pulse rate of a subject (para [0154]) and that a pulse rate is acquired from the subject during an oscillometric method (i.e., inflation of a cuff, see para [0006]) (para [0052] and [0101]).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the maximum value depends on one or more of: a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed; and an amplitude of a signal indicative of pressure oscillations detected in the wearable cuff during inflation of the wearable cuff at the first inflation speed, in view of the teachings of Sawanoi, for the obvious advantage of being able to taken measurement of patients that even have a faint pulse (see para [0154] of Sawanoi).
Kobayashi and Sawanoi do not expressly disclose wherein the maximum value is determined such that an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval.
However, Aelen teaches wherein an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude (claim 5) (also see para [0028], [0100]-[0101], and [0137]), and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval (claim 5) (also see para [0028], [0100]-[0101], and [0137]).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the maximum value is determined such that an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval, in view of the teachings of Aelen, for the obvious advantage of avoiding tissue damage, pateitn discomfort, and measurement inaccuracy.
For claim 16, Kobayashi discloses a tangible, non-transitory computer readable medium that stores computer readable code (42) (Fig. 1) (para [0051]), which when executed by a processor, causes the processor to:
with a pump (51) (Fig. 1) (para [0054]), initiate inflation of a wearable cuff for use in measuring blood pressure at a first inflation speed (20) (Fig. 1) (para [0050]); and
change a first inflation speed during inflation of the wearable cuff by controlling the pump (para [0065]), wherein the first inflation speed is changed at a rate that is limited to a maximum value by a limiter (“control signal,” from 115, para [0065]).
Kobayashi does not expressly disclose wherein the maximum value depends on one or more of: a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed; and an amplitude of a signal indicative of pressure oscillations detected in the wearable cuff during inflation of the wearable cuff at the first inflation speed.
However, Sawanoi teaches limiting an inflation speed based on a pulse rate of a subject (para [0154]) and that a pulse rate is acquired from the subject during an oscillometric method (i.e., inflation of a cuff, see para [0006]) (para [0052] and [0101]).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the maximum value depends on one or more of: a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed; and an amplitude of a signal indicative of pressure oscillations detected in the wearable cuff during inflation of the wearable cuff at the first inflation speed, in view of the teachings of Sawanoi, for the obvious advantage of being able to taken measurement of patients that even have a faint pulse (see para [0154] of Sawanoi).
Kobayashi and Sawanoi do not expressly disclose wherein the maximum value is determined such that an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval.
However, Aelen teaches wherein an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude (claim 5) (also see para [0028], [0100]-[0101], and [0137]), and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval (claim 5) (also see para [0028], [0100]-[0101], and [0137]).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the maximum value is determined such that an induced change in cuff pressure over a maximum-to-minimum oscillation interval is less than a predetermined fraction of the oscillation amplitude, and wherein the oscillation amplitude is a difference between the maximum and the minimum pressure values of the oscillation over the maximum-minimum oscillation interval, in view of the teachings of Aelen, for the obvious advantage of avoiding tissue damage, pateitn discomfort, and measurement inaccuracy.
For claim 17, Kobayashi further discloses increase the inflation speed during inflation of the wearable cuff; or decrease the first inflation speed during inflation of the wearable cuff (as can be seen in Fig. 7) (also see para [0065]).
For claim 18, Kobayashi further discloses wherein the first inflation speed is changed at a rate that is the maximum value or a rate that is less than the maximum value (as can be seen in Fig. 7) (also see para [0065]).
For claim 19, Kobayashi further discloses wherein the first inflation speed is changed at a rate that is variable or a rate that is constant (as can be seen in Fig. 7) (also see para [0065]).
For claim 23, Kobayashi further discloses acquire a signal indicative of the pressure oscillations detected in the wearable cuff during inflation of the wearable cuff (para [0063] and [0065]) (also see para [0069], [0077], [0092], and [0143]; and determine a blood pressure value for the subject based on the acquired signal (para [0063] and [0065]) (also see para [0069], [0077], [0092], and [0143].
Claim(s) 6 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in Sawanoi and Aelen, and further in view of view of U.S. 2011/0077535 to Chen et al. (hereinafter “Chen”).
For claim 6, Kobayashi, Sawanoi, and Aelen do not expressly disclose wherein the maximum value is equal to or less than 16 mmHg/s2.
However, Chen teaches an inflation phase (42) (Fig. 3) where a maximum value of the rate of change of the inflation speed is equal to or less than 16 mmHg/s2 (para [0049] and [0063], one speed being 5 mmHg over 0.5 to 1.5 seconds, the next speed being 10 mmHg over 0.5 to 1.5 seconds, therefore the difference between those two speeds being 5 mmHg over 0.5 to 1.5 seconds) (alternatively, see the negative changes in inflation speed in Fig. 3 of the inflation phase 42).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the maximum value is equal to or less than 16 mmHg/s2, in view of the teachings of Chen, for the obvious advantage of not speed up inflation too fast to minimize any discomfort felt by the patient.
For claim 20, Kobayashi, Sawanoi, and Aelen do not expressly disclose wherein the maximum value is equal to or less than 16 mmHg/s2.
However, Chen teaches an inflation phase (42) (Fig. 3) where a maximum value of the rate of change of the inflation speed is equal to or less than 16 mmHg/s2 (para [0049] and [0063], one speed being 5 mmHg over 0.5 to 1.5 seconds, the next speed being 10 mmHg over 0.5 to 1.5 seconds, therefore the difference between those two speeds being 5 mmHg over 0.5 to 1.5 seconds) (alternatively, see the negative changes in inflation speed in Fig. 3 of the inflation phase 42).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the maximum value is equal to or less than 16 mmHg/s2, in view of the teachings of Chen, for the obvious advantage of not speed up inflation too fast to minimize any discomfort felt by the patient.
Claim(s) 7 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in view of Sawanoi and Aelen, and further in view of U.S. 2016/0100765 to Muehlsteff et al. (hereinafter “Muehlsteff”).
For claim 7, Kobayashi, Sawanoi, and Aelen do not expressly disclose wherein the apparatus is configured to: change the first inflation speed based on a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed.
However, Muehlsteff teaches wherein the apparatus is configured to: change the first inflation speed based on a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed (105 and 107 in Fig. 3) (also see the rest of the method in Fig. 3 all the way to step 119) (also see para [0050]-[0051]).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the apparatus is configured to: change the first inflation speed based on a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed, in view of the teachings of Muehlsteff, for the obvious advantage of stopping inflation of the cuff at the earliest opportunity to avoid discomfort to the subject due to excess pressure and duration of a blood pressure measurement (see para [0050]-[0051] of Muehlsteff).
For claim 21, Kobayashi, Sawanoi, and Aelen do not expressly disclose change the first inflation speed based on a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed.
However, Muehlsteff teaches change the first inflation speed based on a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed (105 and 107 in Fig. 3) (also see the rest of the method in Fig. 3 all the way to step 119) (also see para [0050]-[0051]).
It would have been obvious to a skilled artisan to modify Kobayashi to include change the first inflation speed based on a pulse rate acquired from the subject during inflation of the wearable cuff at the first inflation speed, in view of the teachings of Muehlsteff, for the obvious advantage of stopping inflation of the cuff at the earliest opportunity to avoid discomfort to the subject due to excess pressure and duration of a blood pressure measurement (see para [0050]-[0051] of Muehlsteff).
Claim(s) 12 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi in view of Sawanoi and Aelen, and further in view of U.S. Patent No. 4,493,326 to Hill et al. (hereinafter “Hill”).
For claim 12, Kobayashi, Sawanoi, and Aelen do not expressly disclose wherein the acquired signal is in a frequency range from 0.5 Hz to 5 Hz.
However, Hill teaches wherein the acquired signal is in a frequency range from 0.5 Hz to 5 Hz (col. 8, lines 25-47).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the acquired signal is in a frequency range from 0.5 Hz to 5 Hz, in view of the teachings of Hill, for the obvious advantage of decreasing artifact interference during measurement.
For claim 22, Kobayashi, Sawanoi, and Aelen do not expressly disclose wherein the acquired signal is in a frequency range from 0.5 Hz to 5 Hz.
However, Hill teaches wherein the acquired signal is in a frequency range from 0.5 Hz to 5 Hz (col. 8, lines 25-47).
It would have been obvious to a skilled artisan to modify Kobayashi wherein the acquired signal is in a frequency range from 0.5 Hz to 5 Hz, in view of the teachings of Hill, for the obvious advantage of decreasing artifact interference during measurement.
Response to Arguments
Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 12/23/25.
However, to address Applicant’s argument that the applied references do not teach a rate-of-change of an inflation speed (i.e., an acceleration), Kobayashi explicitly discloses a “speed of change” (i.e., an acceleration) (see para [0065]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791