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 .
Response to Amendment
The amendment filed January 7th 2026 has been entered. Claims 1 and 3-5 are pending in the application. Applicant’s amendments to the Claims have not overcome each and every objection previously set forth in the Non-Final Office Action mailed 10/31/2025.
Claim Objections
Claim 1 is objected to because of the following informalities:
Regarding claim 1, “one controlled pump (3) per supply line (2) for supplying liquid” should be corrected to “one controlled pump (3) per the at least one supply line (2) for supplying the flushing liquid” and “the subject’s” should be corrected to “a subject’s” for claim language consistency and correctness.
Appropriate correction is required.
Applicant is advised that should claim 1 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Möllstam (US 20150290387 A1), in view of Friedman (US 20030167012 A1).
Regarding claims 1 and 5, 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.
However, Friedman teaches a medical device (patient monitor 10, [0016]) 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 (pulse oximeter 26 used for non-invasive, continuous measurement of blood pressure, abstract, [0003], [0016], [0021] & Fig. 1-3).
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 Friedman 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 since Friedman teaches a pulse oximeter to be an art effective sensor for continuously and non-invasively measuring blood pressure and would yield the same predictable results pertaining to perfusion pressure monitoring (see [0003] and [0036] of Friedman). Such a modification would no longer require an incision through the patient’s skin for inserting a catheter for blood pressure measurement ([0002] of Friedman). As modified, patient monitor 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.
Regarding claims 3-4, Möllstam 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 January 7th 2026 have been fully considered but they are not persuasive. The Examiner notes that the default target pressure (DP-dt), during a procedure, can be, and is being interpreted as, the latest adjusted target pressure (DP-at). The initial default target pressure (DP-dt), set by an operator, does not have to be interpreted as the baseline (see [0144]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783