DETAILED ACTION
This detailed action is in response to the amendments and arguments filed on 06/08/2026, and any subsequent filings.
Notations “C_”, “L_” and “Pr_” are used to mean “column_”, “line_” and “paragraph_”.
Claims 1-4 are pending.
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 Arguments
Double Patenting
The non-statutory double patenting rejection has been removed.
Claim Rejections - 35 USC § 112
Due to the Applicant’s amendments, the previous 35 USC § 112 rejections have been removed.
Claim Rejections - 35 USC § 102
The Applicant argues that reference Ritter does not teach the amended Claim 1 (pg. 8-11). This argument is unpersuasive because this is directed towards the amended claim.
Claim Rejections - 35 USC § 103
The Applicant argues that references Yardimci and Meyer do not disclose or suggest the limitations of the amended Claim 1 (pg. 11-13). This argument is unpersuasive because this is directed towards the amended claim.
Response to Amendment
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.
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.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication US20140217020A1 (‘Meyer’) in view of U.S. Publication US20140112828A1 (‘Grant’) and in further view of European Patent EP3335742B1 (‘Ritter’. Machine translations accompany this detailed action and the claims are mapped to those translations and the drawings in the original documents).
The Applicant’s claims are directed towards an apparatus.
Regarding Claims 1-3, Meyer teaches a blood purification apparatus (abstract) configured to purify a patient's blood by causing the blood to extracorporeally circulate (Fig. 1, [0307], extracorporeal flow path 100) through a blood purifier and a blood circuit, the blood purification apparatus comprising:
a line section including a dialysate introduction line (Fig. 1, [0321], line comprising inlet 506) through which dialysate is to be introduced into the blood purifier, and a drain-liquid discharge line (Fig. 1, [0315], line comprising outlet 507) through which drain liquid is to be discharged from the blood purifier, the line section further including an A-drug-solution introduction line (Fig. 1, [0376], line comprising port 522), a B-drug-solution introduction line (Fig. 1, [0376], line comprising port 523), and a circulatory line (Fig. 1C, [0314], de-aeration path 112);
a delivery unit (Fig. 1, [0318], dialysate pump 305) configured to deliver fluid in the line section;
an A-drug infusion pump (Fig. 1, [0350], salination pump) configured to introduce an A-drug solution ([0350], sodium chloride) into the dialysate introduction line through the A-drug-solution introduction line;
a heating unit (Fig. 1, [0314], heater 708) attached to the dialysate introduction line (Fig. 1); and
a control unit configured to control operation of the delivery unit, the A-drug infusion pump ([0415]) and the heating unit ([0330]) to execute a blood purification treatment process ([0429]), a bicarbonate-solution-generating process ([0140]), and a defatting washing process,
the blood purification treatment process including preparing the dialysate by mixing (Fig. 1, [0320], mixer 704) the A-drug solution and the B-drug solution introduced into the line section and diluting the A-drug solution and the B-drug solution to predetermined concentrations ([0359] and [0434]),
the bicarbonate-solution-generating process including generating a bicarbonate solution by causing the B-drug solution introduced into the line section to circulate through the circulatory line and heating the B-drug solution with the heating unit ([0318]),
causing the bicarbonate solution generated in the bicarbonate-solution-generating process to flow through the line section (Fig. 1, [0374]),
wherein the control unit causes carbon dioxide ([0092]) to be discharged to an outside of the line section ([0314], degassing and de-aeration).
Meyer does not teach a B-drug infusion pump configured to introduce a B-drug solution into the dialysate introduction line through the B-drug-solution introduction line, wherein the control unit is configured to control operation of the B-drug infusion pump and to execute a defatting washing process, the defatting washing process to remove oil and fat, wherein the control unit causes carbon dioxide to be discharged during the defatting washing process.
Grant also relates to a blood purification apparatus configured to purify a patient's blood by causing the blood to extracorporeally circulate through a blood purifier and a blood circuit (abstract), including a B-drug infusion pump (Fig. 6, [0170], bicarbonate pump 183) configured to introduce a B-drug solution into the dialysate introduction line through the B-drug-solution introduction line (Fig. 6),
the control unit configured to control operation of the B-drug infusion pump ([0180]).
Ritter also relates to a blood purification apparatus configured to purify a patient's blood by causing the blood to extracorporeally circulate through a blood purifier and a blood circuit ([0016]), including a defatting washing process to remove oil and fat ([0032]), wherein the control unit ([0031], device control system) causes carbon dioxide to be discharged during the defatting washing process ([0031] and [0053]), the carbon dioxide being generated when the bicarbonate solution is caused to flow ([0053]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the blood purification apparatus of Meyer to comprise a B-drug-solution pump, as demonstrated by Grant, to ensure that each ingredient is added to the line at proper concentrates (Grant, [0170]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the control unit of the combination of Meyer and Grant to be configured to execute a defatting washing process, as demonstrated by Ritter, so cleaning using an acidic concentrate is followed by a second process step of cleaning with bicarbonate to form a complete post-therapy process (Ritter, [0019]. Note that Meyer may employ citric acid as a cleaning and disinfectant chemical, Meyer, [0371]). Furthermore, subsequent cleaning with bicarbonate, which is used to mix the dialysis fluid (see Meyer, [0350]), reduces the production of plastic waste (Ritter, [0021]) and the number of chemicals required (Ritter, [0020] and [0023]), thus simplifying the handling of the machine (Ritter, [0020]).
Additional Disclosures Included:
Claim 2: the dialysate introduction line includes a trap (Meyer, Fig. 1 and 16, [0321] and [0361-0362], degassing module 705) configured to capture, in the blood purification treatment process, bubbles in the dialysate (Meyer, [0374]) while allowing the dialysate to flow through the trap, and wherein the trap captures carbon dioxide (Meyer, [0374]) during the defatting washing process (Ritter, [0053]) when the bicarbonate solution generated in the bicarbonate-solution-generating process is caused to flow through the line section (It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the trap of the combination of Meyer, Grant and Ritter to capture carbon dioxide during the defatting washing process, as demonstrated by Ritter, because both Meyer and Ritter are concerned with cleaning and disinfecting a dialysis device (Meyer, abstract and Ritter, [0001])).
Claim 3: a fluid-pressure detector (Meyer, Fig. 1D and 1E, [0321], pressure sensors 604, 606) configured to detect fluid pressure, the fluid-pressure detector being provided on the dialysate introduction line at a location on a downstream side (Meyer, Fig. 1E) or an upstream side relative to the trap, wherein, when a predetermined change in the fluid pressure is detected by the fluid-pressure detector during the defatting washing process, the control unit causes the carbon dioxide captured by the trap to be discharged to the outside of the line section (Meyer, [0321] and [0324]) (It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the control unit to cause the carbon dioxide captured by the trap to be discharged when the fluid-pressure detector of the combination of Meyer, Grant and Ritter detects a predetermined change in the fluid pressure, as demonstrated by Meyer, to selectively permit gas to flow between the trap and the atmosphere and prevent air ingress to the trap if the fluid pressure drops to less than a predetermined amount greater than atmospheric pressure (Meyer, [0321] and [0324]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication US20140217020A1 (‘Meyer’), U.S. Publication US20140112828A1 (‘Grant’) and in further view of European Patent EP3335742B1 (‘Ritter’. Machine translations accompany this detailed action and the claims are mapped to those translations and the drawings in the original documents) as applied to claim 3 above, and further in view of U.S. Publication US20180243494A1 (‘Meyer 2’).
The Applicant’s claims are directed towards an apparatus.
Regarding Claim 4, the combination of Meyer, Grant and Ritter teaches the blood purification apparatus of Claim 1, including that the line section includes a bypass line connecting the drain-liquid discharge line (Meyer, Fig. 1, [0315], bypass flow path 111) and an on-off valve configured to open and close (Meyer, Fig. 1, [0321], vent control valve 410), and wherein, when a predetermined change in the fluid pressure is detected by the fluid-pressure detector during the defatting washing process, the control unit opens the on-off valve to cause the carbon dioxide in the first region to be discharged to the outside of the line section (Meyer, [0321] and [0324]),
except that the trap includes a first region that is an upstream part of the trap, the first region being configured to store captured bubbles, and a second region that is a downstream part of the trap, the second region being configured to allow the dialysate received to flow through the second region, wherein the bypass line connects the first region and the drain-liquid discharge line such that the first region communicates with the drain-liquid discharge line, and an on-off valve configured to open and close the bypass line, and wherein, when a predetermined change in the fluid pressure is detected by the fluid-pressure detector during the defatting washing process, the control unit opens the on-off valve to cause the carbon dioxide in the first region to be discharged to the outside of the line section through the bypass line and the drain-liquid discharge line.
Meyer also relates to a blood purification apparatus configured to purify a patient's blood by causing the blood to extracorporeally circulate through a blood purifier and a blood circuit (abstract), including that the trap (Fig. 1A, [0099], degasser) includes a first region that is an upstream part of the trap (Fig. 1A, [0100], upper section of degasser that comprises degas sprayer 18), the first region being configured to store captured bubbles (Fig. 1A, [0100], gas space 21), and a second region that is a downstream part of the trap (Fig. 1A, [0100], lower section of degasser that comprises lower level sensor 17), the second region being configured to allow the dialysate received to flow through the second region (Fig. 1A),
wherein the bypass line connects the first region and the drain-liquid discharge line such that the first region communicates with the drain-liquid discharge line (Fig. 12, [0128], degassing outlet line 43 can be connected to drain line 46),
the control unit opens the on-off valve to cause the carbon dioxide in the first region to be discharged to the outside of the line section ([0023]) through the bypass line and the drain-liquid discharge line ([0128]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the trap of the combination of Meyer, Grant and Ritter to be the trap of Meyer 2 because other types of degassing modules may be employed in the blood purification apparatus of Meyer (Meyer, [0327]) and because connecting the degassing outlet line to the drain line muffles the noise of a vacuum pump (Note that Meyer may employ degassing modules using vacuum, Meyer, [0327]) and directs any condensed water vapor to a reservoir (Meyer 2, [0128]).
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 BOI-LIEN THI NGUYEN whose telephone number is (703)756-4613. The examiner can normally be reached Monday to Friday, 8 am to 6 pm.
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/BOI-LIEN THI NGUYEN/Examiner, Art Unit 1779
/Bobby Ramdhanie/Supervisory Patent Examiner, Art Unit 1779
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