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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 25, 2026 has been entered.
Response to Arguments
Applicant's arguments filed May 25, 2026 have been fully considered but they are not persuasive. Amendments to the current set of claims have changed the scope of the claimed invention, and newly found secondary reference Hacker et al., (“Hacker”, US 2017/0209638), in combination with the previous prior art references used.
On pages 8-9 of the Remarks section, as indicated by the page number on the bottom of each page, Applicant discusses the status of the claims, the previous interview held, as well as the objection to the Specification. The Examiner has withdrawn the previous Specification objection as a result.
On pages 9-10, Applicant discusses the previous 103 prior art rejection, and summarizes the present claimed invention, and its benefits. Applicant continues to describe and summarize the disclosures used for each of primary reference Ash et al., (“Ash”, US 4,995,268), and secondary reference Crnkovich et al., (“Crnkovich”, US 2018/0318486. Applicant argues that neither Ash and Crnkovich disclose supplying dialysis liquid from the dialysis liquid circuit to the extracorporeal circuit via the membrane. Applicant notes that it was discussed having the dialysis liquid directly supplied to the membrane by Examiner in the interview. The Examiner notes however that the current set of claims does not specifically make clear that the dialysis liquid must be added directly from the dialyzing circuit to the membrane into the extracorporeal blood circuit. The Examiner interprets that adding dialysis liquid from the dialyzing circuit to the extracorporeal blood circuit and having it pass through the membrane reads upon the claimed invention as currently written still. Applicant also argues that Ash does not provide dialysate fluid during the blood reinfusion process to displace blood present in the extracorporeal circuit. The Examiner notes that Ash explicitly states that the blood is rinsed from the dialyzer membrane, and the arterial and venous line in column 13, lines 9-39, of Ash. Applicant also characterizes Crnkovich as only using an ultrafiltration pump to withdraw blood, and not to push dialyzing liquid through the dialyzer as claimed. However, the Examiner notes that paragraph [0218] of Crnkovich makes clear that blood and dialysate are driven through/out of the dialyzer membrane. The Examiner finds these remarks by Applicant unpersuasive as a result.
On pages 12-13, Applicant argues that Crnkovich does not motivate a combination with Ash. The Examiner notes that Crnkovich does demonstrate generating higher/excess pressure in its system to drive more blood using less substituate (dialyzing liquid), (See paragraphs [0218] & [0220], Crnkovich).
Furthermore, the Examiner notes that additional new secondary reference Hacker explicitly discloses returning the blood to the patient using both the arterial and venous line in parallel, (Arterial Blood Line 9 joined to Venous Section 23a at Connection Point 24 thus both arterial and venous sections return blood in parallel, See Figure 2, See paragraph [0131], Hacker). Thus, the Examiner finds Applicant’s remarks against Ash and Crnkovich moot since Hacker discloses this feature instead.
On pages 13-16, Applicant argues that the other secondary references used for the 103 prior art rejections of dependent claims do not disclose the above indicated claim features of independent Claims 1 & 14. The Examiner notes that a combination of Ash, Crnkovich, and new secondary reference Hacker, discloses the features discussed for the reasons stated above, and further demonstrated in the prior art rejection section below. Thus, these remarks are considered moot.
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 (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 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.
Claim(s) 1-3, 6, 9-11, 14 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ash et al., (“Ash”, US 4,995,268), in view of Crnkovich et al., (“Crnkovich”, US 2018/0318486), in further view of Hacker et al., (“Hacker”, US 2017/0209638).
Claims 1-3, 6, 9-11 & 15 is directed to an extracorporeal blood treatment device, an apparatus type invention group.
Regarding Claims 1-3, 6, 9-11 & 15, Ash discloses an extracorporeal blood treatment device, (See Abstract, See column 1, lines 8-11, Ash), comprising: an extracorporeal circuit comprising an arterial section and a venous section, (Arterial Line 102/Measurement Channel 101 and Venous Line 106, See Figure 1, See column 5, lines 35-59), a dialyzer having a membrane, (Blood therapy instrument 104, See Figure 1, See column 5, lines 43-52, column 13, lines 9-20), and a dialyzing liquid circuit, (Lines 44/45 connected to Dialyzer 33, See Figure 2, See US 4,661,246, incorporated by reference according to column 5, lines 46-54, Ash), the extracorporeal circuit and the dialyzing liquid circuit being separated from each other by the membrane, (See column 5, lines 46-54, Ash, and See US 4,661,246); an arterial blood pump that pumps blood in a therapy direction from a patient through the extracorporeal circuit to the dialyzer during treatment, (Roller 119 on Arterial line 102 from patient, See column 12, lines 24-28, Ash); a first sensor being provided in the venous section, the first sensor being configured to acquire a hematocrit percentage in liquid flowing through the venous section, (Photoemitter 129 next to Venous Line 106, See Figures 6 & 1, See column 8, lines 9-46, Ash); a second sensor being provided in the arterial section, the second sensor being configured to acquire a hematocrit percentage in liquid flowing through the arterial section, (Photoemitter 128 next to Measurement Channel 101, See Figures 6 & 1, See column 8, lines 9-46, Ash); and the extracorporeal blood treatment device further comprising a control unit configured to control a reinfusion of blood by operating the arterial blood pump against the therapy direction, (See column 7, lines 28-54, Ash), such that a dialyzing liquid from the dialyzing liquid circuit passes through the membrane to the extracorporeal circuit, during the reinfusion of blood, so as to displace the blood present in the extracorporeal circuit towards a patient to return the blood present in the extracorporeal circuit to the patient via both the venous section and the arterial section, (Control Unit 111 and Interface 143 connected to and controlling Sensor Unit 110 including Emitters 128/129, See Figure 1, See column 6, lines 15-32, See column 13, lines 9-31), the control unit being configured to discontinue the reinfusion of blood via the venous section when the hematocrit percentage acquired by the first sensor or calculated or predicted by the control unit based on information acquired by the first sensor falls below a predetermined limit value, (See column 13, lines 9-24), the control unit further being configured to discontinue the reinfusion of blood via the arterial section, (See column 13, lines 9-31).
Ash does not explicitly disclose operating the arterial blood pump to create an excess pressure in the dialyzing liquid circuit, return the blood present to the patient in parallel, or that the control unit is configured to discontinue the reinfusion via the arterial section when the hematocrit percentage acquired by the second sensor or calculated or predicted by the control unit based on information acquired by the second sensor falls below the predetermined limit value.
Crnkovich discloses operating the arterial blood pump to create an excess pressure in the dialyzing liquid circuit, (See paragraph [0218], Crnkovich), displacing the blood with the dialyzing liquid, (See paragraphs [0027], [0028], [0218], Crnkovich), and that the control unit is configured to discontinue the reinfusion via the arterial section when the hematocrit percentage acquired by the second sensor or calculated or predicted by the control unit based on information acquired by the second sensor falls below the predetermined limit value, (See paragraph [0118] & [0058], Crnkovich).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of Ash by incorporating that the control unit is configured to discontinue the reinfusion via the arterial section when the hematocrit percentage acquired by the second sensor or calculated or predicted by the control unit based on information acquired by the second sensor falls below the predetermined limit value as in Crnkovich to “contribute to improving the effectiveness of the arterio-venous blood return, that is to say the simultaneous reinfusion both via the arterial and via the venous patient connection” and “ it may be carried out easily and may not require any technically complex, time- and/or cost-intensive steps”, (See paragraphs [0188] & [0189], Crnkovich), in which “the transition from blood to substituate is thus sharper” and “less substitutate is required for flushing out the blood/substituate mixture”, (See paragraph [0220], Crnkovich).
Modified Ash does not explicitly disclose returning the blood present to the patient in parallel using both the arterial section and the venous section.
Hacker discloses returning the blood present to the patient in parallel using both the arterial section and the venous section, (Arterial Blood Line 9 joined to Venous Section 23a at Connection Point 24 thus both arterial and venous sections return blood in parallel, See Figure 2, See paragraph [0131], Hacker).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of modified Ash by incorporating returning the blood present to the patient in parallel using both the arterial section and the venous section as in Hacker in order to “thus offer the advantage of basically completely regaining the blood present in the line interior of an extracorporeal blood circuit after that has been used for a blood treatment for the patient”, (See paragraph [0109], Hacker), while “the step of retrogradely pushing out the blood present in the arterial connection needle…may thus advantageously be avoided’, (See paragraph [0108], Hacker).
Additional Disclosures Included:
Claim 2: The extracorporeal blood treatment device according to claim 1, wherein the predetermined limit value is less than or equal to 10%, (See column 13, lines 20-22, Ash; anticipates the claimed range at 3% or less).
Claim 3: The extracorporeal blood treatment device according to claim 1, further comprising wherein the arterial blood pump is in the arterial section, and is configured for a change of direction of rotation, (Roller 119 on Arterial line 102 from patient, See column 12, lines 24-28, Ash), and the control unit controls the arterial blood pump during the reinfusion of blood via the arterial section so that the arterial blood pump rotates against the therapy direction, (See column 7, lines 28-54, Ash).
Claim 6: The extracorporeal blood treatment device according to claim 1, wherein the control unit is configured to control the reinfusion of blood as a function of the dialyzer used, (Control Unit 111 and Interface 143 connected to and controlling Sensor Unit 110 including Emitters 128/129, See Figure 1, See column 6, lines 15-32, See column 13, lines 9-31).
Claim 9: The extracorporeal blood treatment device according to claim1, wherein the first sensor is a venous safety air detector with integrated red detector, which is configured to detect air or air bubbles in the liquid flowing through the venous section, (Detector 131 with Detector 129, as part of Sensor 110, See Figure 6, See column 8, lines 9-46, Ash), and to acquire the hematocrit percentage of the liquid as termination criterion of the reinfusion of blood via the venous section, (Detector 131 with Detector 129, as part of Sensor 110, See Figure 6, See column 8, lines 9-46, Ash), and wherein the second sensor is an arterial safety air detector with integrated red detector, which is configured to detect air or air bubbles in the liquid flowing through the arterial section and to acquire the hematocrit percentage of the liquid as termination criterion of the reinfusion of blood via the arterial section, (Detector 130 with Detector 128, as part of Sensor 110, See Figure 6, See column 8, lines 9-46, Ash).
Claim 10: The extracorporeal blood treatment device according to claim 7, wherein the first sensor is a venous safety air detector with integrated red detector, which is configured to detect air or air bubbles in the liquid flowing through the venous section and to acquire the hematocrit percentage of the liquid as termination criterion of the reinfusion via the venous section, (Detector 131 with Detector 129, as part of Sensor 110, See Figure 6, See column 8, lines 9-46, Ash ), and in that the second sensor is a hematocrit sensor which is configured to acquire information about the hematocrit percentage in the liquid during the reinfusion of blood and to forward said information to the control unit, (Detector 130 with Detector 128, as part of Sensor 110, See Figure 6, See column 8, lines 9-46, Ash).
Claim 11: The extracorporeal blood treatment device according to claim 10, wherein the control unit is configured to make, based on the information about the hematocrit percentage in the liquid, a calculation or a prediction as to when the hematocrit percentage of the liquid falls below the predetermined limit value, (See column 12, lines 29-48, Ash; See paragraph [0232] & [0233], Crnkovich).
Claim 15: The extracorporeal blood treatment device according to claim 1, wherein the predetermined limit value for the hematocrit percentage is between 1% and 5%, (See column 13, lines 20-22, Ash; anticipates/overlaps with the claimed range at 3% down to 1%).
Regarding Claim 14, Ash discloses a method for automatically performing a reinfusion of blood after a blood treatment therapy, the method comprising the steps of: operating an arterial blood pump to pump a dialyzing liquid against a therapy direction, (See column 7, lines 28-54, Ash), during the reinfusion of blood such that the dialyzing liquid passes from the dialyzing liquid circuit via a membrane of a dialyzer to an extracorporeal circuit, (Blood therapy instrument 104, See Figure 1, Lines 44/45 connected to Dialyzer 33, See Figure 2, See column 13, lines 9-20, See US 4,661,246, incorporated by reference according to column 5, lines 46-54, Ash), the extracorporeal circuit and the dialyzing liquid circuit being separated from each other by a membrane provided in the dialyzer, (See column 5, lines 46-54, Ash, and See US 4,661,246); displacing, the blood present in the extracorporeal circuit towards a patient, (See column 13, lines 9-16, Ash); returning of the blood to the patient via both a venous section of the extracorporeal circuit and an arterial section of the extracorporeal circuit, (See column 13, lines 9-32); discontinuing of the reinfusion of blood via the venous section when a hematocrit percentage of a liquid containing blood flowing through the venous section is acquired by a first sensor provided in the venous section if, based on information acquired by the first sensor, the hematocrit percentage falls below a predetermined limit value, (See column 13, lines 9-24); and discontinuing of the reinfusion of blood via the arterial section, (See column 13, lines 9-24).
Ash does not explicitly disclose operating the arterial blood pump to create an excess pressure in a dialyzing liquid circuit, displacing with the dialyzing liquid the blood, returning both the blood and the dialyzing liquid to the patient in parallel via both the venous section and the arterial section, or to discontinue the reinfusion if the hematocrit percentage is acquired by a second sensor provided in the arterial section or if, based on information acquired by the second sensor, the hematocrit percentage is predicted or calculated to fall below the predetermined limit value.
Crnkovich discloses operating the arterial blood pump to create an excess pressure in a dialyzing liquid circuit, displacing with the dialyzing liquid the blood, (See paragraph [0027], [0028], [0218], Crnkovich), and that the control unit is configured to discontinue the reinfusion if the hematocrit percentage is acquired by a second sensor provided in the arterial section or if, based on information acquired by the second sensor, based on information acquired by the second sensor, the hematocrit percentage is predicted or calculated to fall below the predetermined limit value, (See paragraph [0118] & [0058], Crnkovich).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of Ash by incorporating operating the arterial blood pump to create an excess pressure in a dialyzing liquid circuit, displacing with the dialyzing liquid the blood and discontinuing the reinfusion if the hematocrit percentage is acquired by a second sensor provided in the arterial section or if, based on information acquired by the second sensor, the hematocrit percentage is predicted or calculated to fall below the predetermined limit value as in Crnkovich to “contribute to improving the effectiveness of the arterio-venous blood return, that is to say the simultaneous reinfusion both via the arterial and via the venous patient connection” and “ it may be carried out easily and may not require any technically complex, time- and/or cost-intensive steps”, (See paragraphs [0188] & [0189], Crnkovich), in which “the transition from blood to substituate is thus sharper” and “less substitutate is required for flushing out the blood/substituate mixture”, (See paragraph [0220], Crnkovich).
Modified Ash does not disclose returning both the blood and the dialyzing liquid to the patient in parallel via both the venous section and the arterial section.
Hacker discloses returning the blood present to the patient in parallel using both the arterial section and the venous section, (Arterial Blood Line 9 joined to Venous Section 23a at Connection Point 24 thus both arterial and venous sections return blood in parallel, See Figure 2, See paragraph [0131], Hacker).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of modified Ash by incorporating returning the blood present to the patient in parallel using both the arterial section and the venous section as in Hacker in order to “thus offer the advantage of basically completely regaining the blood present in the line interior of an extracorporeal blood circuit after that has been used for a blood treatment for the patient”, (See paragraph [0109], Hacker), while “the step of retrogradely pushing out the blood present in the arterial connection needle…may thus advantageously be avoided’, (See paragraph [0108], Hacker).
Claim(s) 7 & 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ash et al., (“Ash”, US 4,995,268), in view of Crnkovich et al., (“Crnkovich”, US 2018/0318486), in further view of Hacker et al., (“Hacker”, US 2017/0209638), in further view of Kamen et al., (“Kamen”, US 2010/0192686).
Claim 7 is directed to an extracorporeal blood treatment device, an apparatus type invention group.
Regarding Claim 7, modified Ash discloses the extracorporeal blood treatment device according to claim 1, wherein the control unit is configured to perform an operation, after a blood treatment therapy and before the reinfusion of blood, (See paragraph [0002], Crnkovich).
Modified Ash does not disclose the control unit performing the operation including a safety air removal step, by which air or, respectively, an air bubble is removed from the arterial section.
Kamen discloses the control unit performing the operation including a safety air removal step, by which air or, respectively, an air bubble is removed from the arterial section, (See paragraph [0481], Kamen; air is purged in the method provided when applied to the blood rinseback by connecting the arterial section directly to the venous air trap).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the extracorporeal blood treatment device of modified Ash by incorporating the control unit performing the operation including a safety air removal step, by which air or, respectively, an air bubble is removed from the arterial section as in Kamen in order to “prevent any air caught in the blood flow path at the top of the blood pump cassette…from being inadvertently rinsed back towards the patient’s vascular access”, (See paragraph [0481], Kamen).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ash et al., (“Ash”, US 4,995,268), in view of Crnkovich et al., (“Crnkovich”, US 2018/0318486), in further view of Hacker et al., (“Hacker”, US 2017/0209638), in further view of Kamen et al., (“Kamen”, US 2010/0192686), in further view of Caleffi et al., (“Caleffi”, US 2010/0274171).
Claim 8 is directed to an extracorporeal blood treatment device, an apparatus type invention group.
Regarding Claim 8, modified Ash discloses he extracorporeal blood treatment device according to claim 7, further comprising an arterial tube clamp provided in the arterial section, (Claim 118 and Roller 119 in Arterial Line 102, See Figure 1), and, wherein the control unit performs the safety air removal step such that initially the arterial section is clamped off for a predetermined period of time via the arterial tube clamp, while the arterial blood pump continues to run in the therapy direction, (See paragraph [0481], Kamen), wherein a resulting negative pressure, (See column 11, lines 5-19, Ash; moving blood pump in this direction creates negative pressure), carries away the air or, respectively, air bubble present in the arterial section and conveys the air or, respectively, air bubble into the venous section, where the air or, respectively, air bubble is eliminated, (See paragraph [0481], Kamen).
Modified Ash does not disclose a venous expansion chamber or eliminating the air in the venous expansion chamber.
Caleffi discloses a venous expansion chamber and eliminating the air in the venous expansion chamber, (See paragraph [0029] & [0057], Caleffi).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the extracorporeal blood treatment device of modified Ash by incorporating a venous expansion chamber and eliminating the air in the venous expansion chamber as in Caleffi so that it “avoids the risk of introducing solid particles or air bubbles into the patient connected to the circuit”, (See paragraph [0012], Caleffi).
Claim(s) 12 & 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ash et al., (“Ash”, US 4,995,268), in view of Crnkovich et al., (“Crnkovich”, US 2018/0318486), in further view of Hacker et al., (“Hacker”, US 2017/0209638), in further view of Olde et al., (“Olde”, US 2013/0006130).
Claims 12 & 13 are directed to an extracorporeal blood treatment device, an apparatus type invention group.
Regarding Claim 12, modified Ash discloses the extracorporeal blood treatment device according to claim 11, wherein the control unit is configured to make the calculation or the prediction when performing the reinfusion of blood via the venous section and the reinfusion of blood via the arterial section serially or when a reinfusion flow in the arterial section or the venous section is at least 75 ml/min or, respectively, is greater than a predetermined threshold value, (Control Unit 111 and Interface 143 connected to and controlling Sensor Unit 110 including Emitters 128/129, See Figure 1, See column 6, lines 15-32, See column 13, lines 9-31; rinsing done in one line then done in both lines “serially”).
Modified Ash does not disclose using a linear function as the calculation or the prediction.
Olde discloses an extracorporeal blood treatment apparatus using a linear function as the calculation or the prediction, (See paragraph [0144] or [0107]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of modified Ash by incorporating using a linear function as the calculation or the prediction as in Olde in order to provide “determination of linear…relationships that may exist” using “calibration”, (See paragraph [0097], Olde), which “may provide improved accuracy”, (See paragraph [0107], Olde).
Regarding Claim 13, modified Ash discloses the extracorporeal blood treatment device according to claim 11, wherein the control unit is configured to make the calculation or the prediction when performing the reinfusion of blood via the venous section and the reinfusion of blood via the arterial section in parallel or when a reinfusion flow in the arterial section or the venous section is less than 75 ml/min or, respectively, is smaller than a predetermined threshold value, (Control Unit 111 and Interface 143 connected to and controlling Sensor Unit 110 including Emitters 128/129, See Figure 1, See column 6, lines 15-32, See column 13, lines 9-31; rinsing is done in the last step using both lines which is considered “parallel”).
Modified Ash does not disclose using a Gaussian function as the calculation or the prediction.
Olde discloses an extracorporeal blood treatment apparatus using a Gaussian function as the calculation or the prediction, (See paragraph [0476]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the apparatus of modified Ash by incorporating using a linear function as the calculation or the prediction as in Olde in order to provide “a standard profile [that] is used as predicted signal profile”, (See paragraph [0476], Olde), so that it “may enable faster determination of the functional state or functional parameter of the fluid containing system”, (See paragraph [0330], Olde).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779
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