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 .
Information Disclosure Statement
The information disclosure statement filed 6/17/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Response to Amendment
The amendment filed 6/11/2026 has been entered. Claims 1 and 3-4 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed 3/11/2026.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, “wherein the changes in the baseline of the subject's pulse curve are determined by evaluating one or more of: minimum-to-minimum changes, maximum-to-maximum changes, courses of a half-amplitude value on a rising and falling flank, evaluation of areas under curve sections, or evaluation of steepness of curve sections” should be corrected to “wherein the changes in the baseline of the subject's pulse curve are determined by evaluating one or more of: minimum-to-minimum changes, maximum-to-maximum changes, courses of a half-amplitude value on a rising and falling flank, areas under curve sections, or steepness of curve sections” for clarity.
Appropriate correction is required.
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.
Claim(s) 1 and 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Möllstam (US 20150290387 A1), in view of Sethi (US 20090326393 A1), or, alternatively, in view of Applicant Admitted Prior Art (AAPA).
Regarding claim 1, Möllstam discloses a medical device for flushing cavities in minimal-invasive surgery (device 1, [0139] and abstract & Fig. 1), comprising:
a reservoir for a flushing liquid (fluid bag 2 containing irrigation fluid, [0141]-[0142] & Fig. 1),
at least one supply line for feeding the flushing liquid into a cavity (tubes 5, 7, 8, and 10 creating a supply line for feeding the irrigation fluid into cavity 3, [0142] & Fig. 1; hereafter referred to as the “inflow supply line”),
one controlled pump per the at least one supply line for supplying liquid to the cavity (first fluid pump device 21 connected to the inflow supply line for supplying irrigation fluid to cavity 3, [0142] & Fig. 1),
at least one suction line (cassette tube 16, [0143] & Fig. 1),
one controlled vacuum pump per the at least one suction line (second fluid pump device 18 connected to tube 16, [0143] & Fig. 1),
a waste container connected to the at least one suction line (waste bag 15 connected to cassette tube 16, [0143] & Fig. 1),
at least one pressure sensor for determining a pressure in the cavity (control unit 19 adapted to calculate pressure in the body cavity 3 based on measured pressure from first fluid measuring device 22, [0151] & Fig. 1-2, and/or the second fluid pressure measuring device 23, [0152] & Fig. 1-2),
a control unit for controlling the pressure in the cavity (“…wherein the first fluid pump device and/or the second fluid pump device is adapted to control the pressure in the body cavity 3 based on said control signal received from the control unit 19.”, see [0151]-[0152] and [0155] & Fig. 1-2),
at least one sensor for continuous measurement of a blood pressure of the subject during the procedure, (blood pressure measuring device 20, [0140] and [0155] & Fig. 1; “catheter… hydraulically connected to a blood pressure transducer, signaling the blood pressure to an electrical amplifier and a further to blood pressure monitoring apparatuses. The advantage of this system is that pressure is constantly monitored beat-by-beat, and a waveform (a graph of pressure against time) can be displayed.”, [0128]; a graph of pressure against time generated by monitoring pressure beat-by-beat is a pulse curve) wherein;
the control unit is configured to: (a) process raw data from the at least one sensor to determine a baseline of a subject’s pulse curve; and (b) control the controlled pump and controlled vacuum pump so as to maintain the pressure in the cavity at a target pressure that is between 5% and 20% above a blood pressure value derived from changes in the baseline of the subject's pulse curve (see [0053], [0087]-[0093], [0128], [0130]-[0131], [0144], and [0155]; Blood pressure measuring device 20 provides signal, the measured blood pressure for a patient under surgery, using constant beat-by-beat monitoring producing a waveform, or a pulse curve ([0128]), to the control unit 19 to dynamically calculate a true perfusion pressure (PP-t), which is the blood pressure in the blood vessels in the cavity and the surrounding tissue. This may be interpreted as control unit 19 processing data from device 20 to determine a baseline of the subject’s perfusion pressure, which is directly dependent on the instantly monitored pulse curve. Control unit 19 further adds an adjustment factor (A), which is a value of 5-15% over the normal perfusion pressure, to the true perfusion pressure (PP-t) to determine an instant deliver-pressure (PP-t+A).
If the instant deliver-pressure (PP-t+A) deviates from the default target pressure (DP-dt), then control unit 19 automatically adjusts the default target pressure (DP-dt), creating a new adjusted target pressure (DP-at), to meet desired pressure requirements and controls the first and second pumps to control the pressure in the cavity so as to maintain the pressure at the adjusted default target pressure (DP-at). The default target pressure (DP-dt), during a procedure, can be, and is being interpreted, as the latest adjusted target pressure (DP-at) ([0144]).
The adjusted default target pressure (DP-at) is a pressure that is between 5-15% above the instantly calculated true perfusion pressure, which includes a blood pressure valve, derived from changes in the subject’s perfusion pressure, which is directly dependent on the instantly monitored pulse curve. The Examiner notes that the adjusted target pressure (DP-at) is disclosed to correspond to the control signal (see [0151])).
Möllstam further discloses that the “the blood pressure measuring device comprises any one of a non-invasive blood pressure meter, an invasive blood pressure meter signal, or a monitoring equipment associated to endoscopic surgery or procedures.” ([0049]).
However, Möllstam fails to explicitly disclose at least one sensor for continuous, non-invasive measurement of a blood pressure of the subject during the procedure, the at least one sensor being selected from a pulse oximeter sensor or an impedance sensor; and wherein the changes in the baseline of the subject's pulse curve are determined by evaluating one or more of: minimum-to-minimum changes, maximum-to-maximum changes, courses of a half-amplitude value on a rising and falling flank, evaluation of areas under curve sections, or evaluation of steepness of curve sections.
However, Sethi teaches a medical device comprising at least one sensor for continuous, non-invasive measurement of a blood pressure of the subject during the procedure, the at least one sensor being a pulse oximeter sensor (continuous, noninvasive blood pressure (CNIBP) monitoring system 10 comprising sensor 12, which may be a pulse oximeter, [0016], [0019]-[0021], [0043], [0049] & Fig. 1-4); and wherein the changes in the baseline of the subject's pulse curve are determined by evaluating areas under curve sections (“blood pressure may be determined by, for example, measuring the area under a pulse or a portion of the pulse in the PPG signal.”, [0003]; also see [0029], [0039], [0042], [0080], and claim 1 & Fig. 9-11B).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Möllstam with Sethi to include at least one sensor for continuous, non-invasive measurement of a blood pressure of the subject during the procedure, the at least one sensor being a pulse oximeter sensor, and wherein the changes in the baseline of the subject's pulse curve are determined by evaluating areas under curve sections,
since Sethi teaches a pulse oximeter, operable to determine changes in the baseline of the subject's pulse curve by evaluating areas under curve sections, to be an art effective sensor and measurement method for continuously and non-invasively measuring blood pressure and would help yield the same predictable results pertaining to blood pressure monitoring (abstract, [0003], [0029], [0080] & Fig. 12 of Sethi). The modification would also no longer require an incision through the patient’s skin for inserting a catheter for blood pressure measurement. As modified, system 10 would be connected to control unit 19 of Möllstam to facilitate continuous, non-invasive measurement of blood pressure to allow for perfusion pressure calculation.
Alternatively, AAPA teaches a pulse oximeter or an impedance sensor to be a sensor for continuous, non-invasive measurement of a blood pressure of a subject, wherein the changes in the baseline of the subject's pulse curve are determined by evaluating one or more of: minimum-to-minimum changes, maximum-to-maximum changes, courses of a half-amplitude value on a rising and falling flank, evaluation of areas under curve sections, or evaluation of steepness of curve sections (see specification page 5 line 3-page 6 line 15).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Möllstam with AAPA to include at least one sensor for continuous, non-invasive measurement of a blood pressure of the subject during the procedure, the at least one sensor being selected from a pulse oximeter sensor or an impedance sensor, and wherein the changes in the baseline of the subject's pulse curve are determined by evaluating one or more of: minimum-to-minimum changes, maximum-to-maximum changes, courses of a half-amplitude value on a rising and falling flank, evaluation of areas under curve sections, or evaluation of steepness of curve sections, since it is known that pulse oximeters and impedance sensors are art effective sensors for continuous, non-invasive measurement of a blood pressure and the measurement methodology would yield predictable results pertaining to continuous blood pressure measurement and the determination of changes in the pulse curve (see specification page 5 line 3-page 6 line 15).
Regarding claims 3-4, Möllstam, as modified, discloses all the limitations of claim 1. Möllstam further discloses the medical device wherein the controlled pump (3) for the flushing liquid supply is a roller wheel pump, and wherein the controlled vacuum pump (4) is a roller wheel pump (see [0140] and [0142-[0143] & Fig. 1).
Response to Arguments
Applicant's arguments filed 6/11/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments that Möllstam does not disclose the processing of raw data to establish a pulse curve baseline, the Examiner finds that control unit 19 processing blood pressure data from device 20 determines a baseline of the subject’s perfusion pressure, which is directly dependent on the instantly monitored pulse curve provided by blood pressure measuring device 20.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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