Prosecution Insights
Last updated: April 19, 2026
Application No. 18/215,520

DIALYSIS SYSTEM HAVING A DISINFECTION UNIT

Non-Final OA §102
Filed
Jun 28, 2023
Examiner
KIM, SUN U
Art Unit
1777
Tech Center
1700 — Chemical & Materials Engineering
Assignee
BAXTER HEALTHCARE SA
OA Round
1 (Non-Final)
78%
Grant Probability
Favorable
1-2
OA Rounds
2y 11m
To Grant
90%
With Interview

Examiner Intelligence

Grants 78% — above average
78%
Career Allow Rate
747 granted / 954 resolved
+13.3% vs TC avg
Moderate +11% lift
Without
With
+11.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
31 currently pending
Career history
985
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
47.2%
+7.2% vs TC avg
§102
21.6%
-18.4% vs TC avg
§112
17.5%
-22.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 954 resolved cases

Office Action

§102
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. Election/Restrictions Applicant's election with traverse of Group I (claims 1-17) in the reply filed on 11/11/2025 is acknowledged. The traversal is on the ground(s) that the explanation if the search and examination of all the claims in an application can be made without serious burden. This is found persuasive. The restriction requirement mailed 9/11/2025 has been withdrawn and all claims 1-20 are examined in this office action. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0331613 A1 to Wieslander et al. (hereinafter “ Wieslander ”). Regarding claim 1, Wieslander teaches a peritoneal dialysis (“PD”) system (see Fig. 1, 4, 6 ; paragraphs 42-49, 55, 58-59, 79, 81-110 ) comprising: a PD machine (cycler 20) including a housing ( 24 )(paragraphs 42-43) , a PD fluid pump ( 5 ) housed by the housing (paragraph 43) , a plurality of PD fluid lines (50, 56 , 60) (paragraphs 47-48) and a plurality of PD fluid line connectors (52, 58, 74, 76, 78, 80a, 82a, 68 ) positioned and arranged at the housing to accept distal ends of the PD fluid lines to perform a disinfection sequence (paragraphs 47-48, 55) ; and a disinfection unit ( paragraphs 92-93: 110: water purification apparatus with disinfection fluid inlet 392a) including a disinfection unit housing (110a) (paragraph 95) , a PD fluid line connector (118, 128) positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for the disinfection sequence (paragraph 99) , a line extending (56, 64a) from the disinfection unit housing for connecting to one of the PD fluid line connectors of the PD machine for the disinfection sequence (paragraph 96) , and a disinfection fluid pump (316) housed by the disinfection unit for pumping disinfection fluid during the disinfection sequence (paragraph 93) . Regarding claim s 2 -3 , Wieslander teaches that the PD fluid pump is set to a free-flow position and operated at a slow speed during the disinfection sequence (paragraph 103) . Regarding claim 4, Wieslander teaches that the disinfection unit includes a control unit (112) configured to cause the disinfection fluid pump to pump the disinfection fluid during the disinfection sequence (paragraphs 93, 100-101) and capable of pumping 200 ml/min to 500 ml/min . Regarding claim s 5 -6 , Wieslander teaches that the disinfection unit includes at least one pressure sensor (308) positioned and arranged to sense a pressure of the disinfection fluid during the disinfection sequence, the at least one pressure sensor having a pressure sensor output to the disinfection unit control unit (112) , and wherein the disinfection unit control unit is configured to use the at least one pressure sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired pressure or within a desired pressure range during the disinfection sequence (paragraphs 89, 92, 94) . Wieslander teaches that the control unit (112) of the disinfection unit (110) may initiate the heat disinfection automatically or by instructions/commands from the cycler (20) i.e. PD machine control unit (22) (paragraphs 42-43, 100). Furthermore evidenced by US 2023/0256150 A1 (see Fig. 1-2, 5; paragraphs 50-53, 60-63). Regarding claim 7, Wieslander teaches that the disinfection unit includes a control unit (112) and a heater (302) under control of the disinfection unit control unit to cause the disinfection fluid heater to heat the disinfection fluid during the disinfection sequence to 85 °C to 95 °C within claimed 70°C to 110°C. ( (paragraphs 99-101). Regarding claims 8-9, Wieslander teaches that the disinfection unit includes at least one temperature sensor (303) positioned and arranged to sense a temperature of the disinfection fluid during the disinfection sequence, the at least one temperature sensor having a temperature sensor output to the disinfection unit control unit (112) , and wherein the disinfection unit control unit is configured to use the at least one temperature sensor output as feedback for operating the disinfection fluid pump so that the disinfection fluid is at a desired temperature or within a desired temperature range during the disinfection sequence (paragraphs 89, 99-101) . Wieslander further teaches that the control unit (112) of the disinfection unit (110) may initiate the heat disinfection automatically or by instructions/commands from the cycler (20) i.e. PD machine control unit (22) (paragraphs 42-43, 100). Furthermore evidenced by US 2023/0256150 A1 (see Fig. 1-2, 5; paragraphs 50-53, 60-63). Regarding claims 10-11, Wieslander teaches that the PD machine includes a heater (paragraph 44) , and wherein the PD machine heater is not powered during the disinfection sequence (paragraph 103: heat disinfection is accomplished by heating water by a heating device 302 in the disinfection unit 100 alone) . Regarding claim 12, Wieslander teaches an implicit switch for the disinfection fluid pump (316) (paragraph 93). Regarding claims 13-14, Wieslander teaches that the control unit (112) of the disinfection unit (110) may initiate the heat disinfection automatically or by instructions/commands from the cycler (20) i.e. PD machine with PD machine control unit (22) (paragraphs 42-43, 100). Regarding claim 15, Wieslander teaches a peritoneal dialysis (“PD”) system (see Fig. 1, 4, 6; paragraphs 42-49, 55, 58-59, 79, 81-110) comprising: a PD machine (cycler 20) including a housing (24)(paragraphs 42-43) , a PD fluid pump (5) housed by the housing (paragraph 43) , a patient line (50) in fluid communication with the PD fluid pump (5) (paragraph 47) , a patient line connector (52) positioned and arranged at the housing to accept a distal end of the patient line to perform a disinfection sequence (paragraph 47) , a plurality of PD fluid lines (50, 56 , 60) (paragraphs 47-48) and a plurality of PD fluid line connectors (52, 58, 74, 76, 78, 80a, 82a, 68) positioned and arranged at the housing to accept distal ends of the PD fluid lines to perform a disinfection sequence (paragraphs 47-48, 55) ; and a disinfection unit (paragraphs 92-93:110: water purification apparatus with disinfection fluid inlet 392a) including a disinfection unit housing (110a)(paragraph 95) , a PD fluid line connector (118, 128) positioned and arranged at the disinfection unit housing for receiving one of the PD fluid lines of the PD machine for the disinfection sequence (paragraph 99) , a line extending (56, 64a) from the disinfection unit housing for connecting to one of the PD fluid line connectors of the PD machine for the disinfection sequence (paragraph 96) , and a disinfection fluid pump (316) housed by the disinfection unit for pumping disinfection fluid during the disinfection sequence (paragraph 93) . Regarding claim 16, Wieslander teaches that the patient line is a dual lumen patient line including a fresh PD fluid lumen and a used PD fluid lumen which are common in PD fluid lines (paragraphs 47, 96). Regarding claim 17, Wieslander teaches that at least one of the patient line, the plurality of PD fluid lines or the line extending from the disinfection unit housing is a flexible line (paragraph 96: flexible drain line 56). Regarding claim 18, Wieslander teaches a peritoneal dialysis (“PD”) system (see Fig. 1, 4, 6; paragraphs 42-49, 55, 58-59, 79, 81-110) comprising: a PD machine (cycler 20) including a PD machine control unit (22) (paragraph 42) , a PD fluid pump (5) under control of the PD machine control unit (22) (paragraph 43) ; and a disinfection unit (paragraphs 92-93:110: water purification apparatus with disinfection fluid inlet 392a) configured to be placed in disinfection fluid communication with the PD machine, the disinfection unit (110) including a disinfection unit control unit (112) configured to be placed in data c ommunication with the PD machine control unit (22) (paragraphs 42, 100) , and a disinfection fluid pump (316) under control of the disinfection unit control unit (112) , wherein the PD machine control unit (22) is configured to automatically command the disinfection unit control unit (112) to cause the disinfection fluid pump to begin pumping disinfection fluid in a disinfection sequence (paragraph 100) . Regarding claim 19, Wieslander teaches that the control unit (112) of the disinfection unit (110) may initiate the heat disinfection automatically or by instructions/commands from the cycler (20) i.e. PD machine with PD machine control unit (22) (paragraphs 42-43, 100). Regarding claim 20, Wieslander teaches an implicit switch for the disinfection fluid pump (316) (paragraph 93). Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2018/0021500 A1 teaches peritoneal dialysis system comprising peritoneal dialysate temperature regulation system (see Figures 1, 5-6, 9). Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT JOHN KIM whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1142 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Maxi Flex . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT IN SUK BULLOCK can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-5954 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /John Kim/ Primary Examiner, Art Unit 1777 JK 12/4/25
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Prosecution Timeline

Jun 28, 2023
Application Filed
Dec 04, 2025
Non-Final Rejection — §102 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12601733
DEVICES FOR PERITONEAL DIALYSATE ANALYSIS
2y 5m to grant Granted Apr 14, 2026
Patent 12594368
PERITONEAL DIALYSIS SYSTEM USING DISINFECTION
2y 5m to grant Granted Apr 07, 2026
Patent 12594367
A SYSTEM AND METHOD FOR PRODUCING FLUID FOR PERITONEAL DIALYSIS
2y 5m to grant Granted Apr 07, 2026
Patent 12594369
WEIGHT-BASED PERITONEAL DIALYSIS SYSTEM INCLUDING A DRAIN TROLLEY
2y 5m to grant Granted Apr 07, 2026
Patent 12589192
PORTABLE DIALYSIS SYSTEM
2y 5m to grant Granted Mar 31, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
78%
Grant Probability
90%
With Interview (+11.2%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 954 resolved cases by this examiner. Grant probability derived from career allow rate.

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