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 .
Election/Restrictions
Claims 15-17 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on February 3, 2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “first balancing device configured to balance a volume conveyed along the first blood circuit” and “second balancing device configured to balance a volume conveyed along the second blood circuit” in claim 8 and “control device configured or programmed to be in signal communication” in claim 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 20, “[a] single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011) and MPEP 2173.05(p). In this case, claim 20 contains both the method steps of using the apparatus and the apparatus, and therefore is indefinite.
Claims 21 is rejected as a dependent of claim 20.
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) 1-7 and 18-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kotanko et al. (US 2019/0216996).
Regarding claim 1, Kotanko discloses a medical function device or arrangement (see Fig. 1) comprising a first blood circuit 120 for withdrawing blood from a patient 102 and reintroducing blood to the patient (see Fig. 1; par. 28); and a second blood circuit 130 for withdrawing blood from a person 104 that is not renally impaired and reintroducing blood to the person that is not renally impaired (see Fig. 1; par. 24, 30), wherein: the first blood circuit and the second blood circuit each comprise an arterial line and a venous line (see Fig. 1; par. 28, 30, arterial line withdraws blood and venous line returns blood); and the medical functional device or the arrangement comprises at least one connecting device 110 for establishing fluid communication between the arterial line of the first blood circuit and the venous line of the second blood circuit and between the arterial line of the second blood circuit and the venous line of the first blood circuit (see Fig. 1, par. 28-30), or the arterial line of the first blood circuit is connected to, or integral with, the venous line of the second blood circuit and the arterial line of the second blood circuit is connected to, or integral with, the venous line of the first blood circuit (see Fig. 1, par. 28-30).
Regarding claim 2, Kotanko further discloses the connecting device 110 comprises, or consists of, one or more connectors configured to establish the fluid communication between (i) the arterial line of the first blood circuit and the venous line of the second blood circuit and (ii) between the arterial line of the second blood circuit and the venous line of the first blood circuit (see Fig. 1; par. 28-30).
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Regarding claim 3, Kotanko discloses a blood treatment component (see par. 28, dialyzer) connected to or configured to be connected to (i) the arterial line and the venous line of the first blood circuit and (ii) the arterial line and the venous line of the second blood circuit (see Fig. 1).
Regarding claim 4, Kotanko discloses the blood treatment component is part of the connecting device and comprises one or more connection sites configured to be connected to the one or more connectors (see Fig. 1; par. 28-30).
Regarding claim 5, Kotanko discloses a blood pump 140 configured to convey blood along the arterial line of the first blood circuit (see Fig. 1; par. 33-36).
Regarding claim 6, Kotanko discloses a blood pump 150 configured to convey blood along the arterial line of the second blood circuit (see Fig. 1; par. 33-36).
Regarding claim 7, Kotanko discloses a device configured to (ii) convey blood along the venous line of the second blood circuit (see par. 33-36, blood pump 150).
Regarding claim 18, Kotanko discloses a blood treatment apparatus (see Fig. 1) for treating a medical fluid (see Abstract) with at least one medical function device according to claim 1 (see rejection of claim 1 above).
Regarding claim 19, Kotanko discloses a method for preparing an arrangement of components for treating a patient by hemodialysis (see par. 6), the method comprising: providing an arrangement according to claim 1 (see rejection of claim 1 above and Fig. 1) and connecting the first blood circuit via the connecting device to the second blood circuit (see Fig. 1).
Regarding claim 20, Kotanko discloses a method for treating a patient using the medical functional device or arrangement of claim 1 (see Fig. 1, par. 6 and rejection of claim 1 above).
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) 8-9, 11, and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kotanko in view of Nikolic et al. (US 2016/0341366).
Regarding claim 8, Kotanko discloses the limitations of claim 1 but does not disclose a first balancing device configured to balance a volume conveyed along the first blood circuit and/or a second balancing device configured to balance a volume conveyed along the second blood circuit. Kotanko discloses that a sensor and pressure monitor may be used with the system (see par. 44).
Nikolic discloses a balancing device 10 configured to balance a volume conveyed along a blood circuit (see Figs. 1a-1b, par. 53) via sensor 101, which captures voltages that arise due to the flow of the dialysis stream in a channel to the dialyzer 11 and flow of dialysis stream from dialyzer (see Fig. 1b, par. 65), and the sensor can then be used to adjust the delivery rate of the ultrafiltration pump so that the desired ultrafiltration rate for dialysis is achieved (see par. 61). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kotanko to further include a balancing device as disclosed by Nikolic in order to help with control of ultrafiltration rate for dialysis, and therefore help control dialysis for treatment.
Regarding claim 9, Kotanko and Nikolic disclose the limitations of claim 8 and Nikolic further discloses the second balancing device comprises at least one flow sensor (see Fig. 1a-1b, par. 58,61-66, 91), wherein the at least one flow sensor is embodied and/or arranged for measuring a flow of the volume along the second blood circuit (see par. 64-65, measures a characteristic of a volume of the flow passing along the second blood circuit).
Regarding claim 11, Kotanko and Nikolic disclose the limitations of claim 9 and Nikolic further discloses the at least one flow sensor comprises an at least two-channel flow sensor (see Fig. 1b, channels 1011 and 1012).
Regarding claim 13, Kotanko and Nikolic disclose the limitations of claim 9 and Nikolic further discloses the balancing device is connected to a control device (see par. 31) configured or programmed to be in signal communication with the flow sensor and to act, as a response to signals transmitted by the flow sensor, in a closed-loop manner on a first blood pump configured to convey blood along the arterial line of the second blood circuit (see Fig. 1a, par. 59, 101-102).
Nikolic in the embodiment disclosed above does not disclose two sensors of the at least one flow sensor, though Nikolic discloses that two of the sensors can be present in the blood conveying fluid system (the first blood circuit) and two in the dialysate-conveying system (second blood circuit) in an alternative embodiment (see par. 9, 64). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the at least one flow sensor be at least two flow sensors, as disclosed by Nikolic, as Nikolic discloses adding such additional sensors being an alternative, which would predictably result in additional sensing via the sensors.
Regarding claim 14, Kotanko discloses the limitations of claim 1 but does not disclose the medical functional device is embodied at least in sections as a cassette or is present thereon or therein. Kotanko discloses that a sensor and pressure monitor may be used with the system (see par. 44).
Nikolic discloses a balancing device 10 configured to balance a volume conveyed along a blood circuit (see Figs. 1a-1b, par. 53) via sensor 101, the balancing device in the form of a cassette (see Fig. 1b), and the sensor which captures voltages that arise due to the flow of the dialysis stream in a channel to the dialyzer 11 and flow of dialysis stream from dialyzer (see Fig. 1b, par. 65), and the sensor can then be used to adjust the delivery rate of the ultrafiltration pump so that the desired ultrafiltration rate for dialysis is achieved (see par. 61). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kotanko to further include a balancing device as disclosed by Nikolic in order to help with control of ultrafiltration rate for dialysis, and therefore help control dialysis for treatment. Consequently, the addition of the cassette would result in the medical device having a cassette embodied or present thereon or therein a section.
Claim(s) 8-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kotanko in view of Heide et al. (DE 102020102485), submitted by Applicant in an IDS and citations below referring to the attached English translation provided.
Regarding claim 8, Kotanko discloses the limitations of claim 1 but does not disclose a first balancing device configured to balance a volume conveyed along the first blood circuit and/or a second balancing device configured to balance a volume conveyed along the second blood circuit. Kotanko discloses that a sensor and pressure monitor may be used with the system (see par. 44).
Heide discloses two flow sensors used for blood-to-blood balancing (see Fig. 4, par. 48, 67), with a differential flow sensor used at both the inlet and outlet of the dialyzer (see par. 48), with that of the inlet determining the difference in flow at the dialyzer inlet for the healthy person and person with renal insufficiency (see par. 49) and that at the dialyzer outlet for the difference in flow from the dialyzer determined for the healthy person and the person with renal insufficiency (see par. 50), such that the net water flow of both people can be deduced by these differences (see par. 51). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include the two flow sensors used for blood-to-blood balancing as disclosed by Heide, as Heide specifically discloses this as helpful for dialysis between a person P1 with renal insufficiency and a healthy person P2 (see Fig. 4), as it is important that the water balance of dialysis patients is not negatively affected during treatment (see par. 3) and such a device would help with this determination.
Regarding claim 9, Kotanko and Heide disclose the limitations of claim 8, and Heide further discloses the first balancing device comprises at least one flow sensor 1 (see Fig. 4), wherein the at least one flow sensor is embodied and/or arranged for measuring a flow of the volume conveyed along the first blood circuit and/or a flow of the volume along the second blood circuit (see Fig. 4, par. 67-69).
Regarding claim 10, Kotanko and Heide disclose the limitations of claim 9 and Heide further discloses the at least one flow sensor comprises a magnetic inductive flow sensor or a section thereof (see par. 2, 6, 24 and Fig. 1 showing details of flow sensor 1 and par. 57-58).
Regarding claim 12, Kotanko and Heide disclose the limitations of claim 10 and Heide further discloses at least two sections of the first blood circuit and/or at least two sections of the second blood circuit are arranged to guide blood through a common magnetic field for at least two magnetic-inductive flow sensors of the at least one flow sensor (see Fig. 4, ,par. 13-15, 17, 43-44, 52, 58) or a corresponding reception of the two sections of the first blood circuit or the second blood circuit is provided in a common magnetic field existing during use of the medical function device or arrangement (see Fig. 4, ,par. 13-15, 17, 43-44, 52, 58).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kotanko in view of Heide in view of Nikolic.
Regarding claim 21, Kotanko discloses the limitations of claim 20 but does not disclose the method further comprising: determining, using at least two flow sensors, a first volume flow in at least the arterial line of the first blood circuit or in the arterial line of the second blood circuit; determining, using the flow sensors a second volume flow in at least the venous line of the first blood circuit or the venous line of the second blood circuit; establishing a fluid balance from at least the first volume flow and the second volume flow; and based on the established fluid balance, controlling at least one of: a volume flow of the first blood circuit or of the second blood circuit, a pump rate of at least one blood pump of the first blood circuit and/or of the second blood circuit or at least one device for variably modifying the flow.
Kotanko discloses that a sensor and pressure monitor may be used with the system (see par. 44).
Heide discloses two flow sensors used for blood-to-blood balancing (see Fig. 4, par. 48, 67), with a differential flow sensor used at both the inlet and outlet of the dialyzer (see par. 48), with that of the inlet determining the difference in flow at the dialyzer inlet for the healthy person and person with renal insufficiency (see par. 49) and that at the dialyzer outlet for the difference in flow from the dialyzer determined for the healthy person and the person with renal insufficiency (see par. 50), such that the net water flow of both people can be deduced by these differences (see par. 51). Therefore, Heide discloses determining, using the at least two flow sensors, a first volume flow in at least the arterial line of the first blood circuit (see Fig. 4); determining, using the flow sensors, a second volume flow in at least the venous line of the first blood circuit (see Fig. 4, ellipse 9); establishing a fluid balance from at least the first volume flow and the second volume flow (see Fig. 9). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include the two flow sensors used for blood-to-blood balancing as disclosed by Heide, as Heide specifically discloses this as helpful for dialysis between a person P1 with renal insufficiency and a healthy person P2 (see Fig. 4), as it is important that the water balance of dialysis patients is not negatively affected during treatment (see par. 3) and such a device would help with this determination.
Nikolic further discloses the balancing device is connected to a control device (see par. 31) configured or programmed to be in signal communication with the flow sensor and to act, as a response to signals transmitted by the sensors related to an established fluid balance, in a closed-loop manner on a first blood pump configured to convey blood along the first blood circuit and/or the second blood circuit (see Fig. 1a, par. 59, 78, 91, 101-103). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to, based on the established fluid balance, control the pump of at least one blood pump of the first blood circuit and/or of the second blood circuit, as disclosed by Nikolic, predictably resulting in control of the device that would help with providing treatment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: De Groot et al., Comparison of large-pore membrane haemodialysis and cross-dialysis in acute hepatic insufficiency in pigs, European Journal of Clinical Investigation (1983) 13, 65-71.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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/ARIANA ZIMBOUSKI/ Primary Examiner, Art Unit 3781
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