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 .
StatusClaims(s) 13-29, is/are filed on 9/20/2023 are currently pending. Claim(s) 25-29 is/are withdrawn, 13-24 is/are rejected.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
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) 13-16, 18-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over WESTON (US 20130018338 A1) in view of MASUDA (JP 2006091127 A) and KODERA (JP 2014020214 A).
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Regarding claim 13, WESTON discloses a medical treatment apparatus (NPWT apparatus 20; [0060]) comprising: a vacuum line (vacuum line 36; [0066]); a negative pressure source in fluid communication with the vacuum line for building up a negative pressure therein (vacuum pump 30; [0063]); a pressure measuring device for measuring pressure values of the negative pressure (primary pressure sensor 102; [0078]); an output device (low pressure LED light 82 / alarm circuit 696; [0073]); a storage device storing a reference value (memory of control unit 1118; [0195]); a control device (vacuum system control device 32; [0063]).
WESTON does not disclose measuring the pressure "while obtaining a measured pressure value profile," a determining device that determines a value to be assessed from that profile, a stored reference pressure profile/reference value for that value, a reading device that reads out the stored reference, and outputting a result of a comparison between the reference and the assessed value.
MASUDA, in the analogous field of vacuum-system integrity monitoring, teaches these features. MASUDA discloses a pressure gauge 5 that obtains a measured pressure value profile ([0049]: "the solid line C … is a pressure change measurement characteristic diagram showing … the pressure inside chamber 1 obtained by measurement of the pressure gauge 5"); a controller 6 functioning as a determining device that determines a value to be assessed from the profile ([0042]); a storage device (ROM of controller 6) storing at least one reference pressure profile/reference value ([0042]): "a ROM that stores … reference data for the pressure change characteristics"; reference change range ΔPr, reference time ΔTr, reference pressure R); a reading device that reads out the stored reference ([0061]: "the reference pressure change range ΔPr derived from the characteristic curve of the dashed line B"); and outputting a result of the comparison ([0063]: "an alarm is issued from the alarm 9 indicating that the vacuum leak … exceeds a preset permissible limit").
WESTON in view of MASUDA does not expressly teach that the stored measure "indicates a present or an existing wear of the negative pressure source," because MASUDA's deterioration relates to the O-ring seal (1a, 11a) rather than the pump. However, KODERA discloses a control unit 40 storing and applying a measure that indicates wear of the negative pressure source itself ([0009]: "a determination means that determines that the wear of the vanes has progressed by a predetermined amount based on the degree of change when the negative pressure of the vacuum pump reaches a target negative pressure value"; [0035]: "if the actual elapsed time is longer than the preset elapsed time, wear of the vane 23 has progressed"), using electric vacuum pump 10, negative pressure sensor 41, and indicator 47 ([0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the negative-pressure medical apparatus of WESTON to obtain a measured pressure value profile and compare it against a stored reference profile/value as taught by MASUDA, and to store and output a measure indicating wear of the negative pressure source as taught by KODERA. The motivation to do so is expressly provided in the references: MASUDA seeks to prevent "unexpected vacuum leaks during operation" and function loss ([0016]), and KODERA seeks to "properly determine the durability life" of the pump before "the vacuum pump suddenly loses its function" ([0004], [0008]). WESTON opens up to this extension, stating its apparatus "may have application to other fields" ([0016]). The combination amounts to the use of known pressure-profile diagnostic techniques to improve a known negative-pressure apparatus in the predictable manner of detecting source degradation before failure.
Regarding claim 14, KODERA teaches an evaluation device configured to assign a measure of wear to the comparison result and to output it (KODERA, control unit 40 / indicator 47; [0035]: "determines from the comparison result that … wear of the vane 23 has progressed"; [0036]: "notifying the outside that the electric vacuum pump 10 has reached the end of its service life").
Regarding claim 15, the combination teaches determining whether the assessed value/result/measure is within predetermined limits or exceeds/falls below a limit value or threshold (MASUDA, controller 6; [0062]–[0063]: "ΔPs is greater than the reference pressure change range ΔPr … exceeds a preset permissible limit"; KODERA, [0035]: "the actual elapsed time is longer than the preset elapsed time").
Regarding claim 16, the combination teaches that the reference value and/or value to be assessed is a time value or a mathematical parameter (MASUDA, measurement time length ΔTs / reference time length ΔTr; [0018]: "a timer for measuring the length of time required … compared with a reference time range ΔTr"; KODERA, operating time T and rate of change ΔP; [0013]).
Regarding claim 18, the combination teaches outputting an acoustic and/or optical alarm should the result or measure assume values defined in advance as impermissible (WESTON, LED light 82 with audible "chirp" and alarm circuit 696; [0073], [0171]: "turn on a piezoelectric beeper or the like and lights"; MASUDA, alarm 9; [0043], [0063]).
Regarding claim 19, the combination teaches that the impermissible values are assumed upon leaving predetermined limits (MASUDA, alarm 9; [0063]: "exceeds a preset permissible limit and that repair or inspection is required").
Regarding claim 20, the combination teaches impermissibility upon falling below a lower limit or exceeding an upper limit, leaving a permissible range, or exceeding a predetermined amount (MASUDA, [0062]–[0063]: "ΔPs is greater than the reference pressure change range ΔPr"; KODERA, [0035]: actual elapsed time longer than the set time).
Regarding claim 21, the combination teaches that the control device causes storing of the result or measure using the storage device (MASUDA, controller 6; [0085]: "the history of the pressure difference between the measured pressure change range ΔPs and the reference pressure change range ΔPr … may be stored").
Regarding claim 22, the combination teaches determining a wear profile for the negative pressure source from the stored results/measures (MASUDA, [0085]: "the value predicted based on the recent linear relationship obtained from the history"; KODERA, durability life determination device 43; [0008]–[0009]). It would have been obvious to accumulate the stored deterioration measures into the predictive relationship of MASUDA to project remaining pump life as in KODERA, for the predictable benefit of scheduling maintenance before failure.
Regarding claim 23, the combination teaches that the determination of the wear profile is a calculation thereof (MASUDA, controller 6 CPU; [0042]: "a built-in CPU that enables processing calculations"; [0085]: "predicted based on the recent linear relationship"; KODERA, calculation means, [0013]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over WESTON (US 20130018338 A1) in view of MASUDA (JP 2006091127 A), KODERA (JP 2014020214 A) and SABINI (US 7112037 B2).
Regarding claim 17, the combination of WESTON/MASUDA/KODERA teaches the value to be assessed as a slope of the negative-pressure profile (KODERA, [0049]–[0050]: "the load change amount ΔP (slope of negative pressure change per unit time)"; "the slope becomes gentler … when performance deteriorates"), but does not expressly recite that the value is an "angle."
SABINI teaches, for pump-degradation detection, characterizing the slope of the performance line as an angle in degrees (SABINI, C6/13-25: test line 54, baseline slope, threshold θ; FIG. 4 description: "a check is made of the test slope to the baseline slope …” if the difference is greater than θ=5 degrees the data is invalid). It would have been obvious to one of ordinary skill in the art to express the pressure-profile slope of KODERA as an angle as taught by SABINI, because a slope and its corresponding angle are mathematically equivalent representations of the same rate-of-change quantity, and SABINI demonstrates that an angular threshold is a conventional and convenient means of flagging pump degradation.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over WESTON (US 20130018338 A1) in view of MASUDA (JP 2006091127 A), KODERA (JP 2014020214 A) and SODERSTROM (US 4252651 A).
Regarding claim 24, WESTON as combined do not teach the apparatus embodied as a blood treatment, hemodialysis, hemofiltration, hemodiafiltration, or separation apparatus. However, this is well-knon. SODERSTROM teaches a hemodialysis apparatus employing a negative-pressure source, a negative-pressure line, transmembrane pressure monitoring, and an alarm (Abstract: "a negative pressure dialysis machine which includes a negative pressure valving system and transmembrane pressure alarm system"). It would have been obvious to one of ordinary skill in the art before the effective filing date to embody the negative-pressure medical apparatus of WESTON as modified as a hemodialysis apparatus of the type disclosed in SODERSTROM. As WESTON expressly contemplates application "to other fields" ([0016]), and applying its negative-pressure-source diagnostic to a hemodialysis machine — a device that conventionally employs a negative-pressure source and pressure-line monitoring — is no more than the use of a known technique to improve a similar device in the same field of medical negative-pressure apparatuses, yielding the predictable benefit of detecting negative-pressure-source wear in a dialysis machine.
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It is noted that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Waqaas Ali whose telephone number is (571) 270-0235. The examiner can normally be reached on M-F 9-5 PM.
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/WAQAAS ALI/Primary Examiner, Art Unit 1777
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