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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/07/2025 has been entered.
Status of Claims
Applicant’s arguments, filed 10/07/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 13-20 continue to be withdrawn per applicant’s election of restriction requirement filed on 01/05/2025.
Applicants have amended their claims, filed 10/07/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant canceled claims 2 and 9-12 in the response filed on 05/12/2025.
Claims 1 and 3-8 are hereby under examination.
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.
Claims 1 and 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Woehrle et al. (WO 2017060436 – previously cited) hereinafter Woehrle in view of Whitaker et al. (US Patent Pub. No. 20050033188) hereinafter Whitaker, and further in view of Ariav et al. (US Patent Pub. No. 20060087325 – previously cited) hereinafter Ariav.
Regarding Claim 1, Woehrle discloses an apparatus (a non-invasive blood pressure monitoring system (page 5; lines 26-27)), comprising:
an inflatable member (blood pressure cuff 101 (page 5, line 32)) configured to apply pressure to a portion of a body of a patient (can be inflated and deflated for occluding the brachial artery of the patient 1 (page 5, lines 32-33; fig 1)),
the inflatable member being configured to be placed in a deflated configuration (the
blood pressure cuff 101...can be...deflated (page 5, lines 32-33; fig 1)), a first inflated configuration, and a second inflated configuration (bring the pressure of the cuff from the first
pressure level to the second pressure level (page 4, lines 12-13)),
a pressure within the inflatable member when the inflatable member is in the second inflated configuration (second pressure level (page 8, line 9)) being greater than a pressure within the inflatable member when the inflatable member is in the first inflated configuration (first pressure level (page 8, line 6); the first pressure level is slightly above the pressure of the cuff 101 when an inflation process starts (t=0), and the second pressure level is any pressure between the first pressure level and the target cuff pressure Ptarget (page 8, lines 6-8; fig 2); the Examiner notes the target cuff pressure is the maximum pressure of the cuff as seen in fig 2 and therefore the second pressure level would be greater than the first pressure level; see annotated fig 1 based on fig 2 of Woehrle);
a sensor configured to detect vibrations associated with the flow of blood within the body of the patient when the inflatable member is in the second inflated configuration (the pressure transducer 103 is used to sense pressure oscillations in the cuff 101 that are generated by pressure changes in the artery under the cuff. (page 6, lines 6-7; fig 1); The cuff pressure for a measurement cycle, as measured by the transducer, is characterized by the wave 201 (page 6, lines 20-21; fig 2); the Examiner notes that oscillations are vibrations), wherein the first inflated configuration is associated with a first pressure that is lower than a diastolic blood pressure of the patient, and wherein the second inflated configuration is associated with a second pressure that is above a systolic blood pressure of the patient (The cuff pressure rapidly increases to a maximum above the patient's systolic P.sub.s pressure and is then deflated in a sequence of steps to a point below the diastolic pressure Pa. (pg. 6, lines 21-23); fig 2; see annotated figure 1 based on fig 2 of Woehrle; Examiner notes that the first pressure level at t=0 would be lower than a diastolic pressure of the patient based on annotated fig 1 and the second pressure level includes Ptarget which is a maximum above the patient's systolic P.sub.s pressure);
and a controller operatively coupled to the sensor and to the inflatable member, the controller being configured to prevent the inflatable member from being placed in a different inflated configuration (the second pressure level is substantially smaller than the target cuff pressure at the end of the inflation operation in order to stop an unnecessary inflation as soon as possible (pg. 4, lines 17-18); the processor 107 reads the cuff inflation parameter values determined during two corresponding inflation operations. The processor 107 also compares the first inflation parameter with the second one in step 203. Based on the result of the comparison, the processor 107 decides in step 204 whether to continue or stop the measurements. (page 7, lines 19-24); fig 4; Examiner notes that stopping the measurements would require stopping inflation).
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Annotated Figure 1
Woehrle fails to disclose a sensor configured to detect vibrations associated with movement of the body of the patient when the inflatable member is in the first inflated configuration and the controller being configured to prevent the inflatable member from being placed in the second inflated configuration in response to the sensor detecting vibrations indicating movement of the body of the patient while the inflatable member is in the first inflated configuration.
However, Whitaker teaches a preventing an inflatable member from being placed in a higher pressure level in response to a sensor detecting movement of a body of a patient exceeds a threshold while in at a first pressure level (A motion detection module configured to receive as input at least a portion of the signal from the sensor performs the determination. [0039]; The process inflates the inflatable chamber or cuff 102 so that sufficient pressure is applied to perform a blood pressure measurement... If the secondary motion/artifact is too large, the inflatable chamber or cuff 102 is deflated [0044]; fig 2). Whitaker also teaches movement of a body of a patient leads to inaccurate blood pressure measurements and continuing with the blood pressure measurement after motion exceeds a threshold provides unnecessary discomfort to the patient as the inflatable member continues to inflate (One common problem is the discomfort associated with the elevated pressure that is applied with such systems. [0002]; A number of problems in addition to discomfort have been observed with systems involving electronic sensors. Some of the problems include the inability to make accurate measurements in the presence of motion in the subject extremity, and the inability to make accurate measurements on very young patients. [0004]).
Woehrle and Whitaker are considered analogous art to the present invention because both inventions are directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the apparatus of Woehrle such that the controller is configured to prevent the inflatable member from being placed in the second inflated configuration in response to the sensor detecting movement of the body of the patient while the inflatable member is in the first inflated configuration, as taught by Whitaker, because it would ensure the blood pressure measurements are taken when the patient is at rest and therefore be more accurate. Furthermore, preventing further inflation of the inflatable member when the blood pressure measurements will not be accurate eases discomfort associated with high pressures that are applied. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Woehrle in view of Whitaker fails to teach a sensor configured to detect vibrations associated with movement of the body of the patient when the inflatable member is in the first inflated configuration and the controller being configured to prevent the inflatable member from being placed in the second inflated configuration in response to the sensor detecting vibrations indicating movement of the body of the patient while the inflatable member is in the first inflated configuration.
However, Ariav teaches a sensor configured to detect vibrations associated with movement of a body of a patient (The sensors… can be designed of such high sensitivity so as to be capable of sensing very small movements or vibrations involving forces of a few grams. [0089]; a plurality of sensors… to sense a particular area of the individual's body in contact with the mattress for any movement, changes in blood flow, etc [0090]).
Ariav is considered analogous art to the present invention because it is reasonably pertinent to the problem faced by the inventor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the apparatus of Woehrle in view of Whitaker such that the sensor is capable of sensing very small movements or vibrations related to movement or changes in blood flow, as taught by Ariav, so that the apparatus can also detect vibrations associated with movement of the body of the patient to ensure the blood pressure measurements are taken when the patient is at rest. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
The apparatus of Woehrle in view of Whitaker, and further in view of Ariav would comprise a sensor configured to detect vibrations associated with movement of the body of the patient when the inflatable member is in the first inflated configuration and the controller would be configured to prevent the inflatable member from being placed in the second inflated configuration in response to the sensor detecting vibrations indicating movement of the body of the patient while the inflatable member is in the first inflated configuration.
Regarding Claim 3, Woehrle in view of Whitaker, and further in view of Ariav teaches the invention as discussed above in claim 1. Woehrle in view of Whitaker, and further in view of Ariav further teaches the controller is configured to prevent the inflatable member from being placed in the second inflated configuration (the processor 107 reads the cuff inflation parameter values determined during two corresponding inflation operations. The processor 107 also compares the first inflation parameter with the second one in step 203. Based on the result of the comparison, the processor 107 decides in step 204 whether to continue or stop the measurements. (page 7, lines 19-24; fig 4 of Woehrle)) in response to the sensor detecting vibrations indicating movement (The sensors… can be designed of such high sensitivity so as to be capable of sensing very small movements or vibrations involving forces of a few grams. [0089]; a plurality of sensors… to sense a particular area of the individual's body in contact with the mattress for any movement, changes in blood flow, etc [0090 of Ariav]) of a hand of the patient while the inflatable member is in the first inflated configuration (A motion detection module configured to receive as input at least a portion of the signal from the sensor performs the determination. [0039 of Whitaker]; The process inflates the inflatable chamber or cuff 102 so that sufficient pressure is applied to perform a blood pressure measurement... If the secondary motion/artifact is too large, the inflatable chamber or cuff 102 is deflated [0044 of Whitaker]; fig 2 of Whitaker; Examiner notes the vibrations would indicate movement of a hand if the sensor was placed on a hand).
Regarding Claim 4, Woehrle in view of Whitaker, and further in view of Ariav teaches the invention as discussed above in claim 1. Woehrle further discloses the inflatable member is a cuff and is configured to be removably coupled to an arm of the patient (an inflatable cuff 101… attached to the measurement site; for example, an upper arm 100 of a patient 1 (page 5, lines 27-29; fig 1); the NIBP monitor indicates that the cuff has been disconnected from the device or is no longer applied to the patient's limb (page 7; lines 6-7).
Regarding Claim 5, Woehrle in view of Whitaker, and further in view of Ariav teaches the invention as discussed above in claim 1. Woehrle discloses the inflatable member is configured to surround a portion of an arm of the patient (an inflatable cuff 101… attached to the measurement site; for example, an upper arm 100 of a patient 1 (page 5, lines 27-29; fig 1)).
Regarding Claim 6, Woehrle in view of Whitaker, and further in view of Ariav teaches the invention as discussed above in claim 1. Woehrle discloses the inflatable member includes an inflation portion and a coupling portion (an inflatable cuff 101… attached to the measurement site; for example, an upper arm 100 of a patient 1 (page 5, lines 27-29; fig 1); the Examiner notes the cuff is inflatable and can attach to a measurement site, therefore, the cuff has an inflatable and a coupling portion).
Regarding Claim 7, Woehrle in view of Whitaker, and further in view of Ariav teaches the invention as discussed above in claim 1. Woehrle in view of Whitaker, and further in view of Ariav further teaches the controller is configured to receive a signal from the sensor (the electrical oscillation signals from the pressure transducer 103 are obtained by the central processor module 107 (page 6, lines 7-9; fig 1 of Woehrle)) when the sensor detects vibrations indicating movement of the body of the patient (The sensors… can be designed of such high sensitivity so as to be capable of sensing very small movements or vibrations involving forces of a few grams. [0089 of Ariav]; a plurality of sensors… to sense a particular area of the individual's body in contact with the mattress for any movement, changes in blood flow, etc [0090 of Ariav]) while the inflatable member is in the first inflated configuration (all measurements are conducted during the inflation process (page 4; lines 23-24); the verification of whether or not an inflatable cuff is attached to the measurement site of a patient is performed during the inflation process (page 7, lines 10-11 of Woehrle); the Examiner notes that the verification process is performed during the first pressure level).
Regarding Claim 8, Woehrle in view of Whitaker, and further in view of Ariav teaches the invention as discussed above in claim 1. Woehrle further discloses an output coupled to the controller (inflation and deflation of the blood pressure cuff 101 is controlled by the central processor 107 through the deflate valve(s) 104 and the inflate valve(s) (105) or source of pressurized air 106, respectively. (page 6, lines 14-16; fig 1)) and configured to provide a signal to inflate the inflatable member; and an input coupled to the controller (The operation of the inflate valve(s) 105 or source of pressurized air 106 is controlled by the central processor module 107 through the control line 111. (page 6, lines 12-13; fig 1); Examiner notes that the central processor module 107 performs the same functions as the claimed output); and an input coupled to the controller (the electrical oscillation signals from the pressure transducer 103 are obtained by the central processor module 107 (page 6, lines 7-9; fig 1); Examiner notes that the central processor module 107 performs the same functions as the claimed input because electrical oscillations are considered motion).
Response to Arguments
Applicant’s arguments, see pages 5-8 of Remarks, filed 10/07/2025, with respect to the first retort of the 35 U.S.C. 103 rejection of claim 1 in view of prior art have been fully considered but they are not persuasive and are moot because the new ground of rejection necessitated by Applicant’s amendments. The rejection of claim 1 is updated as presented above.
Applicant’s arguments, see pages 8-9 of Remarks, filed 10/07/2025, with respect to the second retort of the 35 U.S.C. 103 rejection of claim 1 in view of prior art have been fully considered but are not persuasive and are moot in view of the new grounds of rejections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANKI M BAVA whose telephone number is (571)272-0416. The examiner can normally be reached Monday-Friday 9:00-6:00 ET.
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/JANKI M BAVA/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791