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 .
Response to Arguments
Applicant's arguments filed December 15, 2025 have been fully considered but they are not persuasive. Amendments to the current set of claims have not significantly changed the scope of the claimed invention, and the previous prior art rejections still read upon the claims.
On page 8 of the Remarks section, as indicated by the page number on the bottom of each page, Applicant discusses the status of the claims as well as the objections to the Specification. Particularly, Applicant argues that the request to add publication numbers to the Cross-Reference to Related Applications section is not required. The Examiner notes that this request is intended to make clear to the reader or one of ordinary skill what prior publications the current application claims priority to, and adds ease to finding and reviewing those publications in turn.
On page 8, Applicant also discusses the amendments made to the Specification and the claims to overcome the previous other Specification objection, and previous 112 rejections. Here, the Examiner has withdrawn the objection and 112 rejections in response.
On pages 9-10, Applicant discusses the previous 103 prior art rejection of independent Claim 1 using primary reference Ash et al., (“Ash”, US 4,995,268), and secondary reference Crnkovich et al., (“Crnkovich”, US 2018/0318486). Applicant first summarizes the claimed invention of independent Claim 1. Applicant specifically argues that the present invention uses a reinfusion that does not use an external saline bag or substitute port by instead supplying a dialyzing liquid from the dialyzing liquid circuit via a membrane of a dialyzer to the extracorporeal circuit. On pages 10-11, Applicant asserts that neither primary reference Ash nor secondary reference Crnkovich disclose this particular feature. Applicant summarizes the disclosure of Ash and Crnkovich, which each use sensors to measure hematocrit while priming or rinsing the extracorporeal circuit lines. Applicant argues that Ash does not disclose eliminating the saline bag by supplying dialysis fluid from the dialysis liquid circuit to the membrane, and that Crnkovich uses a substitute line instead as well. Here, the Examiner notes that primary reference Ash was claim mapped to include an incorporation by reference of US 4,661,246, which demonstrates the interconnection of the dialysis circuit to the dialyzer as well, (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 Examiner points to column 14, lines 37-51, of this reference, which demonstrates that the priming solution travels on both sides of the blood circuit and the dialysate circuit and through the dialyzer (membrane) as well. The Examiner also notes that secondary reference Crnkovich while it uses a substitute port to introduce substituate to prime or rinse the blood circuit will drive this substituate directly from the dialysate circuit as shown in Figure 3, and that the substituate can be any fresh dialysis liquid, hence dialysate, (See paragraph [0028], Crnkovich). The Examiner notes also that this fluid while introduced at a point other than the membrane in the extracorporeal circuit will also travel through the membrane as well based on the prior teachings in either Ash, (See column 13, lines 11-16, Ash), or its incorporated reference, (column 14, lines 37-51). Such an action is not excluded by the recited claim language regarding this feature. Thus, the Examiner maintains that these references still disclose the claimed invention as a whole, based on these demonstrated teachings. For these reasons, the Examiner finds Applicant’s remarks here unpersuasive.
On pages 12-14, Applicant discusses the previous prior art rejections of other dependent claims using various other secondary references. Applicant argues that these other references do not disclose the above discussed claim feature. The Examiner notes that Ash and Crnkovich still disclose this feature, so Applicant’s remarks here are considered moot.
Specification
The disclosure is objected to because of the following informalities: please also insert the publication numbers and dates of the applications cited in the Cross-Reference to Related Applications section.
Appropriate correction is required.
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) 1-6, 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).
Claims 1-6, 9-11 & 15 is directed to an extracorporeal blood treatment device, an apparatus type invention group.
Regarding Claims 1-6, 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, (Blood therapy instrument 104, See Figure 1, See 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 a membrane provided in the dialyzer, (See column 5, lines 46-54, Ash, and See US 4,661,246); 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 such that a dialyzing liquid is supplied from the dialyzing liquid circuit via the membrane to the extracorporeal circuit which, during the reinfusion of blood, displaces 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 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 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).
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 an arterial blood pump in the arterial section, the arterial blood pump being 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 controlling the arterial blood pump during the reinfusion of blood via the arterial section so that the arterial blood pump rotates against a therapy direction, (See column 7, lines 28-54, Ash).
Claim 4: The extracorporeal blood treatment device according to claim1, wherein the control unit is configured to perform the reinfusion of blood via the venous section and the reinfusion of blood via the arterial section in parallel, (See column 13, lines 25-32, Ash).
Claim 5: The extracorporeal blood treatment device according to claim1, wherein the control unit is configured to serially perform the reinfusion of blood via the venous section and the reinfusion of blood via the arterial section, (See column 13, lines 10-16; then column 13, lines 24-32, 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: supplying a dialyzing liquid from a 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 of 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 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 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 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).
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 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 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 and an arterial blood pump are 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 a 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 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
THIS ACTION IS MADE FINAL. 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 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