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 .
Specification
Examiner suggests applicants to insert “BRIEF DESCRIPTION OF THE DRAWINGS” between lines 15-16 in page 11.
The disclosure is objected to because of the following informalities:
“Fig. 6” should be corrected to “Fig. 5” on 2nd. Line from the bottom in page 16.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 5 and 13 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Recitation of “the crushing cone” in line 3 of each of claim 5 and line 2 of claim 13 lacks a positive antecedent basis.
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.
Claims 1-3, 5-7, 9-11 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0375835 A1 to Hassler et al. (hereinafter “Hassler”) in view of US 2020/0297909 A1 to Suljevic et al. (hereinafter “Suljevic”).
Regarding claim 1, Hassler discloses (see the abstract; figures 1-4; paragraphs [0008]-[0016]) a method for automatically verifying correct setup of a blood treatment apparatus (paragraph [0008]), a gravimetric cycler for peritoneal dialysis having only one scale, a hose system (paragraph [0008]; figure 2) and a control unit adapted to automatically execute the filling process of the hose system (paragraphs [0008], [0016]-[0020], [0027]) wherein the hose system comprises at least three line portions for connection to at least one drainage bag, at least one solution bag and a patient line (paragraph [0008]; figure 2), wherein, by means of the set of scales, a change in the weight of the solution bag and/or of the drainage bag is detected during the filling process of the hose system and compared to an expected value (paragraph [0011]) and when a deviation of the change in weight of the solution bag and / or the drainage bag from the expected value or a tolerance range of the expected value is determined, the control unit blocks a start of a blood treatment and an output to a user is made (paragraphs [0011]-[0013]).
Claim 1 differs from Hassler in reciting that the output comprising instructions for a problem solving routine.
Suljevic teaches a peritoneal dialysis system comprising a control system (16) for controlling a cycler including generating output comprising instructions for a problem solving routine i.e. troubleshooting routine (see paragraphs [0157], [0246]-[0247]; Fig. 1A, 19: see block 1056 for TROUBLESHOOTING).
It would have been obvious to a person of ordinary skill in the art to include known troubleshooting routine feature in the control unit of Hassler to provide instructions to solve problems as suggested by Suljevic.
Regarding claim 2, Hassler discloses that the filling process of the hose system is performed automatically (paragraph [0008]).
Claim 3 differs from Hassler in reciting that a combined weight and / or a combined change in weight of the solution bag and the drainage bag is determined by means of the scale.
Hassler teaches that the regulation/control unit coupled to the scale to detect the solution bag or its weight (see paragraphs [0008]-[0009]).
Measuring combined weight of the solution bag and the drainage bag by a scale is well-known in the art of extracorporeal blood treatment including peritoneal dialysis.
It would have been obvious to a person of ordinary skill in the art to modify method and system of Hassler to incorporate a detection unit configured to determine a combined weight and / or a combined change in weight of the solution bag and the drainage bag is determined by means of the scale for fine tuning or alternative control of balancing fluid.
Regarding claim 5, Hassler discloses that the output prompts the user to check the crushing cone of the at least one solution bag and / or to check clamps or shut-off elements arranged on the hose system and / or to check whether the line portions of the hose system are correctly connected, in particular whether they are correctly connected to the associated valves (paragraph [0011]).
Regarding claim 6, Hassler discloses that if the comparison does not show any deviation of the change in weight of the solution bag and / or the drainage bag from the expected value or if it is within a tolerance range, a start of a blood treatment is enabled (paragraph [0014]).
Regarding claim 7, Hassler discloses that the weight, the type of hose system, the number and spatial arrangement of the solution bags relative to each other and / or to the blood treatment apparatus are taken into account when determining the expected value of the change in weight during a filling process (paragraphs [0008]-[0009], [0012], [0015], [0043]).
Regarding claim 9, Hassler discloses a blood treatment apparatus (see the abstract; figures 1-4; paragraphs [0008]-[0016]), a gravimetric cycler for peritoneal dialysis, having only one set of scales, a hose system (paragraph [0008]; figure 2), a detection unit, an evaluation unit and a control unit adapted to automatically execute the filling process of the hose system (paragraphs [0008], [0016]-[0020], [0027]) wherein the blood treatment apparatus being adapted to automatically detect a correct setup of the blood treatment apparatus (paragraph [0008]) by the method according to claim 1 wherein the hose system comprising at least three line portions for connection to at least one drainage bag, at least one solution bag and a patient line (paragraph [0008]; figure 2), a detection unit adapted to detect a change in the weight of the solution bag and/or of the drainage bag during a filling process of the hose system by means of the scale, the evaluation unit is adapted to make a comparison of the detected change in weight to an expected value (paragraphs [0011], [0016]-[0020]) and when the comparison shows a deviation of the change in weight of the solution bag and / or the drainage bag from the expected value or a tolerance range of the expected value, the control unit is adapted to block a start of a blood treatment and generate an output to a user (paragraphs [0011]-[0013]).
Claim 9 differs from Hassler in reciting that the output comprising instructions for a problem solving routine.
Suljevic teaches a peritoneal dialysis system comprising a control system (16) for controlling a cycler including generating output comprising instructions for a problem solving routine i.e. troubleshooting routine (see paragraphs [0157], [0246]-[0247]; Fig. 1A, 19: see block 1056 for TROUBLESHOOTING).
It would have been obvious to a person of ordinary skill in the art to include known troubleshooting routine feature in the control unit of Hassler to provide instructions to solve problems as suggested by Suljevic.
Regarding claim 10, Hassler discloses a control unit adapted to automatically execute the filling process of the hose system (paragraphs [0008], [0016]-[0020]) and/or the method for automatically verifying correct setup of a blood treatment apparatus (paragraph [0008]).
Claim 11 differs from Hassler in reciting that a combined weight and / or a combined change in weight of the solution bag and the drainage bag is determined by means of the scale.
Hassler teaches that the regulation/control unit coupled to the scale to detect the solution bag or its weight (see paragraphs [0008]-[0009]).
Measuring combined weight of the solution bag and the drainage bag by a scale is well-known in the art of extracorporeal blood treatment including peritoneal dialysis.
It would have been obvious to a person of ordinary skill in the art to modify method and system of Hassler to incorporate a detection unit configured to determine a combined weight and / or a combined change in weight of the solution bag and the drainage bag is determined by means of the scale for fine tuning or alternative control of balancing fluid.
Regarding claim 13, Hassler discloses that the output prompts the user to check the crushing cone of the at least one solution bag and / or to check clamps or shut-off elements arranged on the hose system and / or to check whether the line portions of the hose system are correctly connected, in particular whether they have been correctly connected to the associated valves, and / or to check whether the correct hose system has been used (paragraph [0011]).
Regarding claim 14, Hassler discloses that a control unit is adapted to enable a start of a blood treatment when the comparison does not show any deviation of the change in weight of the solution bag and / or the drainage bag from the expected value or when the change in weight is within a tolerance range above or below the expected value (paragraph [0014], [0018]).
Regarding claim 15, Hassler discloses that a control unit is adapted to take into account the weight, the number and / or the spatial arrangement of the solution bags relative to each other and / or to the blood treatment apparatus when determining the expected value of the change in weight during a filling process (paragraphs [0008]-[0009], [0012], [0015], [0043]).
.
Allowable Subject Matter
Claims 8 and 16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 5-7, 9-11 and 13-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Amended claims 1 and 9 includes newly claimed subject matter of an output comprising instructions for a problem solving routine. Newly claimed subject matter is rejected with new reference, Suljevic..
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 JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
2/10/26