Prosecution Insights
Last updated: April 19, 2026
Application No. 18/565,022

AN APPARATUS FOR EXTRACORPOREAL BLOOD TREATMENT

Non-Final OA §102§103
Filed
Nov 28, 2023
Examiner
HAN, SETH
Art Unit
3781
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Gambro Lundia AB
OA Round
1 (Non-Final)
59%
Grant Probability
Moderate
1-2
OA Rounds
2y 11m
To Grant
84%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allow Rate
94 granted / 160 resolved
-11.2% vs TC avg
Strong +25% interview lift
Without
With
+24.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
56 currently pending
Career history
216
Total Applications
across all art units

Statute-Specific Performance

§101
0.9%
-39.1% vs TC avg
§103
53.3%
+13.3% vs TC avg
§102
15.6%
-24.4% vs TC avg
§112
20.5%
-19.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 160 resolved cases

Office Action

§102 §103
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. Status of the Claims Claims filed 11/28/2023 has been entered. At entry, claims 23-45 are pending and under consideration. Claim Rejections - 35 USC § 102 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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim s 23, 24 and 42-44 are rejected under 35 U.S.C. 10 2 (a)(1) as being anticipated by Fontanazzi et al ( US 20140088483 A1 ). Regarding claim 23, Fontanazzi teaches an apparatus for extracorporeal blood treatment, the apparatus comprising: a treatment unit (figure 1, treatment unit 2) having a first chamber (figure 1, first chamber 3) and a second chamber (figure 1, second chamber 4) separated from one another by a semipermeable membrane (figure 1, membrane 5) ; a blood removal line (figure 1 and [0244], blood removal line 6 connected with an inlet port of the first chamber 3) connected to an inlet port of the first chamber and predisposed to remove blood from a patient; a blood return line (figure 1 and [0245], blood return line 7 connected to an outlet port of the first chamber) connected to an outlet port of the first chamber and predisposed to return treated blood to the patient, the blood removal line, the blood return line, and the first chamber being part of an extracorporeal blood circuit ( figure 1, extracorporeal blood circuit 8) ; a liquid evacuation line (figure 1 and [0249], evacuation line 10 connected with an outlet port of the second chamber) connected to an outlet port of the second chamber; a supply line (figure 1, dialysis line 11 connected to inlet to the second chamber 4) connected to an inlet port of the second chamber and/or connected to the extracorporeal blood circuit; sensor devices (figure 1 and [0025] sensor means s1-s10 for detecting values assumed during treatment ) for detecting actual values of parameters of the extracorporeal blood treatment; and a control unit (figure 1 [0021-0023] control unit connected with the sensor means and configured to receive prescription values of target parameters to be reached in a predetermined treatment time) connected to the sensor devices and configured to receive prescription values of the parameters to be reached in the patient or to follow over a treatment time and to obtain, through the sensor devices, the actual values of the parameters during the extracorporeal blood treatment, wherein the parameters comprise: a first parameter ([0026] “ a first parameter relating to a blood volume BV % ” ) relating to a variation in blood volume of the patient, a second parameter ( [0027] “ second parameter relating to one value selected from among a group comprising: an ultrafiltration rate UFR through the membrane, a weight loss rate WLR of the patient, and an accumulated weight loss WL ” ) relating to an ultrafiltration flow rate through the semipermeable membrane, a weight loss rate of the patient, or an accumulated weight loss, and a third parameter ([0028] “ a third parameter Cd, Na relating to a conductivity of a liquid crossing the dialysis line and/or the infusion line or to a sodium concentration or another predetermined substance of the liquid crossing the dialysis line and/or the infusion line ” ) chosen from a group consisting of: a conductivity of a liquid crossing the supply line, a conductivity-related parameter of the liquid crossing the supply line, a concentration of sodium in the liquid crossing the supply line, and a concentration-related parameter of sodium in the liquid crossing the supply line, wherein the control unit is configured to perform, at temporally consecutive control instants, a control procedure ([0034]) comprising: calculating ([0032] calculating control values on the basis of the actually values and the prescription values) , on the basis of the actual values and of the prescription values, the following control values to be set during a time interval after the instant in which the control is made: a second parameter control value ([0032] weight loss target value to be reached in the patient in a predetermined treatment time) , and a third parameter control value ([0032] plasma conductivity or sodium concentration target value to be reached in the patient in a predetermined treatment time) , and imposing at least one of the second parameter control value and third parameter control value during the time interval consecutive to the instant in which the control is made such that the actual values of the first parameter track the prescription values of the first parameter over the treatment time ([0021-0023 and 0045-0049 ] imposing control value relative to the weight loss target value or plasma conductivity / sodium concentration target value such that the measured blood volume reaches the target blood volume ) , wherein the prescription value of the third parameter comprises a target plasma conductivity and/or a target concentration of sodium in plasma to be reached in the patient in the treatment time ([0028-0032] the prescription third parameter comprises plasma conductivity or sodium concentration target value to be reached) , and wherein the control unit is further configured to perform, at least at the beginning of the extracorporeal blood treatment, a procedure for estimating the target plasma conductivity and/or the target concentration of sodium in plasma ( figure 4 and [0030-0032] the control unit is configured to perform calculating the target plasma conductivity or sodium concentration to be reached in a predetermined treatment time) . Regarding claim 24, Fontanazzi teaches the apparatus of claim 23. Fontanazzi further teaches wherein the control procedure starts when the procedure for estimating is completed (figure 4 , control procedure at step 102 starts when estimating calculation is complete 100-101). Regarding claim 42 , Fontanazzi teaches the apparatus of claim 23. Fontanazzi further teaches wherein, near an end of the extracorporeal blood treatment, the control procedure comprises: driving the third parameter control values to converge towards the target plasma conductivity and/or the target concentration of sodium in plasma (figure 4 and [0170 and 0363] step 105 including the third parameter control values are within tolerance at the end) target plasma conductivity or sodium concentration to be reached at the treatment in step 105) Regarding claim 43 , Fontanazzi teaches the apparatus of claim 23. Fontanazzi further teaches wherein, at the end of the extracorporeal blood treatment, the control procedure comprises: setting the third parameter control value close or substantially equal to the target plasma conductivity and/or the target concentration of sodium in plasma (figure 4 and [0170 and 0363 ] target plasma conductivity or sodium concentration to be reached at the treatment in step 105) . Regarding claim 44, Fontanazzi teaches the apparatus of claim 23. Fontanazzi further teaches wherein the actual values of the third parameter are values of concentration of sodium in the liquid crossing the supply line ([0084] conductivity of a liquid crossing the dialysis line) ; wherein the control procedure uses a mathematical model ([0050]) , representing kinetics of the solutes in a distribution volume in the patient, in order to determine equivalent sodium concentration values, wherein by equivalent sodium concentration at instant t is intended the constant sodium concentration in the liquid crossing the supply line which ([0050]) , if it were applied at a start of treatment up to an instant, would lead to the same plasma sodium concentration in the patient as is obtained at the same instant with the variation in sodium concentration or conductivity imposed by the control procedure up to time ([0057]) , the control procedure using the equivalent sodium concentration values as actual values of the third parameter for the determination of the control values ([0060]) . 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. Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Fontanazzi et al ( US 20140088483 A1 ) in view of Nilsson ( US 20190374699 A1 ) Regarding claim 39 , Fontanazzi teaches the apparatus of claim 23. Fontanazzi does not expressly teach wherein at least one time during the extracorporeal blood treatment, the control unit is configured to check plasma conductivity and/or concentration of sodium in plasma In the same field of endeavor, namely an apparatus for extracorporeal blood treatment, Nilsson teaches wherein at least one time during the extracorporeal blood treatment, the control unit is configured to check plasma conductivity and/or concentration of sodium in plasma ([0002] determining a blood parameter (e.g., plasma sodium) during a hemodialysis treatment ). T h erefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fontanazzi to incorporate the teachings of Nilsson and check plasma conductivity and/or concentration of sodium in plasma for the purpose of minimize intradialytic side-effects (e.g., weight gain and hypertension) while removing the amount of sodium necessary to avoid sodium overload as taught by Nilsson ([0013]). Claim s 40 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Fontanazzi et al ( US 20140088483 A1 ) in view of Bosetto et al ( US 5938938 A ). Regarding claim 40, Fontanazzi teaches the apparatus of claim 23. Fontanazzi further teaches wherein the control procedure comprises the following sub-steps ([0061]) : receiving the target plasma conductivity and/or the target concentration of sodium in plasma ( figure 4 and [0062] receiving target plasma conductivity or sodium concentration at step 100 ) ; receiving the treatment time (figure 4 and [0063] receiving treatment time value T at step 100) ; and determining, on the basis of the target plasma conductivity and/or on the base of the target concentration of sodium in plasma, a third parameter band (figure 4 [0064 and 0303 ] determining band limits basis of the target plasma conductivity or sodium concentration at step 101) delimited between an upper trajectory and a lower trajectory over the treatment time , wherein the calculated third parameter control values are kept within the third parameter band (figure4 and [0363], Na(t) verified within allowed bands at step 104) . Fontanazzi does not expressly teach the third parameter band delimited between an upper trajectory and a lower trajectory over the treatment time. In the same field of endeavor, namely an automatic dialysis method and apparatus, Bosetto teaches the third parameter band delimited between an upper trajectory and a lower trajectory over the treatment time (figure 6 and col 7 line 10- 55 , upper and lower variation margins (broken lines)). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fontanazzi to incorporate the teachings of Bosetto and provides the third parameter band as claimed for the purpose of providing tailored blood treatment ensuring tolerance variations remain within safe band limits, preventing clinical complications associated with extreme fluctuations as taught by Bosetto (col 6 lines 10-35). Regarding claim 41 , Fontanazzi teaches the apparatus of claim 23. Fontanazzi further teaches wherein the prescription values of the first parameter define a first parameter trajectory (figure 4 and [0023] calculating and defining variation in blood volume trajectory in 101) and tracking the prescription values of the first parameter comprises: keeping or moving the actual values of the first parameter on the first parameter trajectory or in a neighborhood of the first parameter trajectory ( figure 3 and [0363] controlling and adjusting control values within predetermined bands step 104 ) , wherein the prescription values of the second parameter define a second parameter band ( figure 3 and [0027] calculating and defining variation of ultrafiltration rate at in 101 ) delimited between an upper trajectory and a lower trajectory over the treatment time , wherein calculating the second parameter control value ([0064] determining weight loss target parameters) comprises: determining a first error parameter ( figure 3 and [0066] determining first error parameter ) on the basis of: a difference between an actual value of the first parameter at the control instant and a corresponding value on the first parameter trajectory ( figure 3 and [0067] difference between measured value of BV at the control instant and a corresponding value on the target profile BV ) , and a difference between an actual value of the second parameter at the control instant and a corresponding value of the second parameter band ([0068] different between a measured value of weight loss or weight loss rate ) ; calculating the second parameter control value on the basis of the first error parameter and of the actual value of the second parameter relating to a preceding control instant ( [0074] weight loss rate is calculated on the basis of the first error parameter and on the basis of the ultra-filtration flow rate relating to the proceeding control instant ) , wherein calculating the third parameter control value comprises: determining a second error parameter ([0070]) on the basis of: a difference between an actual value of the first parameter at the control instant and a corresponding value on the first parameter trajectory ( [0072] difference between the measured value of the first parameter BV at the constant instant t and the corresponding value on the target profile ) , and a difference between an actual value of the third parameter at the control instant and a corresponding value of the third parameter band ([0071]) ; and calculating the third parameter control value on the basis of the second error parameter and of the actual value of the third parameter relating to a preceding control instant ([0073]) . Fontanazzi does not expressly teach the third parameter band delimited between an upper trajectory and a lower trajectory over the treatment time. In the same field of endeavor, namely an automatic dialysis method and apparatus, Bosetto teaches the third parameter band delimited between an upper trajectory and a lower trajectory over the treatment time (figure 6 and col 7 line 10-55, upper and lower variation margins (broken lines)). Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fontanazzi to incorporate the teachings of Bosetto and provides the third parameter band as claimed for the purpose of providing tailored blood treatment ensuring tolerance variations remain within safe band limits, preventing clinical complications associated with extreme fluctuations as taught by Bosetto (col 6 lines 10-35). Allowable Subject Matter Claim s 25-38 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. The following is a statement of reasons for the indication of allowable subject matter: No prior art, alone or in combination, could be found teach the procedure for (claim 25) estimating comprises: setting an initial set point of the third parameter of the liquid crossing the supply line and preparing a corresponding liquid through the preparation line; after setting the initial set point, starting extracorporeal blood treatment by circulating the liquid through the supply line and by circulating blood through the extracorporeal blood circuit; measuring an initial value of the third parameter of the dialysate in the liquid evacuation line at the beginning of the extracorporeal blood treatment; calculating, based on the measured initial value of the third parameter of the dialysate in the liquid evacuation line, an initial value of plasma conductivity and/or an initial value of concentration of sodium in plasma; and setting the initial value of plasma conductivity as the target plasma conductivity and/or setting the initial value of concentration of sodium in plasma as the target concentration of sodium in plasma. E xaminer did not find any teachings/motivation to modify the device to incorporate the claimed limitation above , specifically measuring value of the third parameter of the in the liquid evacuation line. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design. Claims 26-38 are allowable for at least being dependent of Claim 25. Similarly , Claim 45 recites a procedure for estimating the target plasma conductivity and/or the target concentration of sodium in plasma comprising: setting an initial set point of the third parameter of the liquid crossing the supply line and preparing a corresponding liquid through the preparation line, after setting the initial set point, starting extracorporeal blood treatment by circulating the liquid through the supply line and by circulating blood through the extracorporeal blood circuit, measuring an initial value of the third parameter of the dialysate in the liquid evacuation line at the beginning of the extracorporeal blood treatment, calculating, based on the measured initial value of the third parameter of the dialysate in the liquid evacuation line, an initial value of plasma conductivity and/or an initial value of concentration of sodium in plasma, wherein the control unit is configured to calculate the initial set point of the third parameter in the liquid crossing the supply line as a function of a dialysate flow rate at the outlet of the second chamber and/or as a function of a clearance of the treatment unit, setting the initial value of plasma conductivity as the target plasma conductivity and/or setting the initial value of concentration of sodium in plasma as the target concentration of sodium in plasma, and after calculating the initial value of plasma conductivity, driving a liquid regulating device for regulating a composition of the liquid crossing the supply line to change said composition of the liquid crossing the supply line to reach a liquid conductivity substantially equal to the initial value of plasma conductivity. Accordingly, Claim 45 is allowed over the prior art. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nilsson ( US 20190374699 A1 ) Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SETH HAN whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-2545 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 0900-1700 . 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 Sarah Al-Hashimi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-7159 . 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. /SETH HAN/ Examiner, Art Unit 3781
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Prosecution Timeline

Nov 28, 2023
Application Filed
Mar 20, 2026
Non-Final Rejection — §102, §103 (current)

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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
59%
Grant Probability
84%
With Interview (+24.7%)
2y 11m
Median Time to Grant
Low
PTA Risk
Based on 160 resolved cases by this examiner. Grant probability derived from career allow rate.

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