DETAILED ACTION
This action is in response to the amendments and remarks filed 11/07/2025, in which claims 1 and 4-7 are pending, claim 1 having been amended.
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 1 and 4-7 are rejected under 35 U.S.C. 112(b) 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.
Claim 1 recites the limitations “for storing the inflow filter coupling when the inflow filter coupling is dismantled after a treatment” and “for storing the outflow filter coupling when the outflow filter coupling is dismantled after a treatment”. It is not clear what is meant by “dismantled” because to park the respective connector and the respective parking station would require that they be physically connected in some way, thus it will be interpreted to mean they are dismantled from the filter after a treatment.
Claims 4-7 are rejected for depending from an indefinite claimed.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2019/0001041 A1 (hereinafter “Ritter”).
Regarding Claim 1 Ritter discloses a dialysis machine 1 having a dialysate side that includes a dialyzer holder (clamping arm 26) configured for holding a dialyzer (filter element/dialyzer 2), the dialysis machine comprising:
two hydraulic connectors (treatment liquid connectors 20 and 21) at the dialysate side, the two hydraulic connectors comprising an inflow connector 20 for feeding fresh dialysis liquid to the dialyzer, and an outflow connector 21 for draining consumed dialysate from the dialyzer 2,
an inflow connection line 27 and an inflow filter coupling (quick disconnect 36 on the end of line 27), the inflow connection line having a first end connected to the inflow connector and a second end connected to the inflow filter coupling,
an outflow connection line 29 and an outflow filter coupling (quick disconnect 36 on the end of line 29), the outflow connection line having a first end connected to the outflow connector and a second end connected to the outflow filter coupling,
an inflow parking station (considered to be flushing connector 22) associated with the inflow connector (seen to be the quick disconnect 36 on hose segment 27), the inflow parking station is seen as being configured for parking the inflow filter coupling for storing the inflow filter coupling when the inflow filter coupling is dismantled after a treatment and not in operation, wherein the inflow connector for feeding fresh dialysis liquid to the dialyzer, and the inflow parking station, are arranged together, in direct proximity, at a first position of the dialysis machine (this limitation describes what the parking station is for and thus is considered to be a functional limitation), and
an outflow parking station (considered to be flushing connector 23) associated with the outflow connector (seen to be the quick disconnect 36 on hose segment 29), the outflow parking station being configured for parking the outflow filter coupling for storing the outflow filter coupling when the outflow filter coupling is dismantled after a treatment and not in operation, wherein the outflow connector for draining consumed dialysate from the dialyzer, and the outflow parking station, are arranged together, in direct proximity, at a second position of the dialysis machine, (see Figs. 12-13, [0049]-[0054], [0058]),
with regard to functional limitations, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114), and thus the prior art need only disclose structure capable of achieving the recited function(s) to read on the functional limitations. It is specifically noted that the claim thus does not positively claim the inflow/outflow filter couplings being stored at the respective parking stations. These functional limitations do not further define over the prior art because the structure disclosed by Ritter would be capable of the noted functional limitation(s), i.e. even though the specific functions are not disclosed, because the inflow/outflow filter couplings may be stored on the flushing connectors 22 and 23 when not in use.
Further wherein
the inflow connector and the outflow parking station are arranged spaced apart from one another by a first distance, the inflow connection line 27 has a length that is less than the first distance (the length of line 27 is “such that the hose segment 27 can only connect the dialysate connector 20 to the flushing connector 22, but not the dialysate connector 20 to the flushing connector 23” [0055]),
the outflow connector and the inflow parking station are arranged spaced apart from one another by a second distance, the outflow connection line 29 has a length that is less than the second distance, (the length of “hose segment 29 can only connect the dialysate connector 21 to the flushing connector 23, but not the dialysate connector 21 to the flushing connector 22.” [0055]);
the inflow filter coupling can neither reach nor be parked at the outflow parking station (the length of line 27 is “such that the hose segment 27 can only connect the dialysate connector 20 to the flushing connector 22, but not the dialysate connector 20 to the flushing connector 23” [0055]), and
the outflow filter coupling can neither reach nor be parked at the inflow parking station (the length of “hose segment 29 can only connect the dialysate connector 21 to the flushing connector 23, but not the dialysate connector 21 to the flushing connector 22.” [0055]).
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Regarding Claim 4 Ritter discloses the dialysis machine in accordance with claim 1, wherein the dialyzer holder 26 is configured and arranged at the machine such that when a dialyzer 2 is placed in the holder the dialyzer is spatially disposed between the inflow connector and the outflow connector, (See Fig. 12,13).
Regarding Claim 5 Ritter discloses an apparatus comprising the dialysis machine in accordance with claim 4, and a dialyzer 2 placed in the dialyzer holder 26, wherein
the dialyzer has an input 28 for inputting fresh dialysis liquid, and an output 30 arranged spaced apart from the input, for outputting consumed dialysate, and
the input of the dialyzer and the outflow connector are spaced apart from one another by a distance that is greater than the length of the outflow connection line (the length of “hose segment 29 can only connect the dialysate connector 21 to the flushing connector 23, but not the dialysate connector 21 to the flushing connector 22.” [0055], and where the input of the dialyzer 28 is farther from the outflow connector 23 then it is from the outflow parking station/flushing connector 22 in Fig. 12. Therefore the distance must be greater than the length of the outflow connection line.), and
the output of the dialyzer and the inflow connector are spaced apart from one another by a distance that is greater than the length of the inflow connection line (the length of line 27 is “such that the hose segment 27 can only connect the dialysate connector 20 to the flushing connector 22, but not the dialysate connector 20 to the flushing connector 23” [0055], and where the output of the dialyzer 30 is farther from the inflow connector 20 then it is from the inflow parking station/flushing connector 23 in Fig. 12. Therefore the distance must be greater than the length of the outflow connection line.).
Regarding Claim 6 Ritter discloses the dialysis machine in accordance with claim 1, further comprising a dialyzer 2 held by the dialyzer holder 26, (See Fig. 12,13).
Regarding Claim 7 Ritter discloses dialysis machine in accordance with claim 6, wherein the dialyzer 2 has an input 28 and an output 30, the inflow filter coupling 36 is connected to the input, and the outflow filter coupling 36 is connected to the output (See Fig. 12,13).
Response to Arguments
Applicant's arguments filed 11/07/2025 have been fully considered but they are not persuasive.
In response to Applicants’ argument that in claim 1 “dismantled” means disconnected from the dialyzer and also not connected to a flushing system, and is therefore not indefinite; the Examiner disagrees. The term “dismantled” is seen to provide the same confusion for interpretation as the previous term “unconnected”, in that the inflow/outflow parking stations and the respective inflow/outflow filter couplings of the instant invention are physically connected. That they are dismantled “after a treatment” does not provide further structural context because this is an apparatus claim, not a method, and thus the timing of a connection cannot be given patentable weight; claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114).While Applicants note that “dismantled” means disconnected from the dialyzer and also not connected to a flushing system; this is not supported by the broadest reasonable interpretation of the claims; notably a flushing system would not be used during treatment, but in a separate step before or after treatment because the system cannot be connected to the flush system and the filter, which is needed for treatment, at the same time. It is suggested that Applicants’ amend the limitations to recite that the inflow/outflow filter couplings are dismantled after a treatment and not in operation such that they are only fluidly connected to the machine through the respective inflow/outflow connection line.
In response to Applicants’ argument that “if the filter coupling (i.e., dialysate connector 20) were "parked" at the flushing connector 22, and the flushing connector 22 were to be considered an inflow parking station, then the dialysate connector 20 would then not be an inflow connector for feeding fresh dialysis liquid to the dialyzer”; the Examiner disagrees.
First, the Examiner would like to acknowledge the confusing labeling of the items in the Figures of Ritter and the resulting confusion in the rejection and discussion. It is noted that liquid connectors 20, 21 and flushing connectors 22 and 23 are stationary on the machine, where hose segments 27 and 29 are used to connect liquid connectors 20 and 21 to either dialyzer connections 28 and 30, or alternatively to flushing connectors 22, 23, depending on if it is a treatment or flushing process respectively. The quick disconnects 36 are used to form the physical connection between the hose segments and the liquid or flushing connectors. So the claimed “inflow filter coupling” and “outflow filter coupling” would be the quick disconnects 36 attached to the ends of house segments 27 and 29. To the argument that when the hose segments are connected for flushing, they are then not “for feeding fresh dialysis liquid to the dialyzer” and/or “for draining consumed dialysate from the dialyzer”, the Examiner disagrees because the houses and thus their connectors may be and are used for both connection to the dialyzer as claimed and for flushing and thus they are still seen as “for feeding fresh dialysis liquid to the dialyzer” and “for draining consumed dialysate from the dialyzer” as claimed. The claims do not make clear what is connected when things are “dismantled after treatment”, and more specifically the limitations to the parking stations are seen to be functional because they are described in terms of what they are for, and thus this is not seen to positively claim the inflow/outflow filter couplings actually being “parked” at the parking stations, but merely having parking stations that can function this way. Claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114).
Applicant’s further argue that the flushing connectors 22 and 23 cannot be considered the inflow/outflow parking stations as claimed; to which the Examiner disagrees. Applicants’ argue that Figures 12 and 13, on which the Examiner relies, do not show connection of the hose segments 27 and 29 to the flushing connectors 22 and 23 and thus do not support the rejection. However, as noted above, the parking stations are described in terms of what they are for, and thus does not positively claim the connectors being stored at the parking stations. The hose segments 27 and 29 are described as being connected to flushing connectors 22 and 23 when flushing, and is shown in Fig. 10; Figs. 12 and 13 are relied upon in the rejection because they shown embodiments where the flushing connectors 22 and 23/“parking stations” are arranged most similarly to that claimed, though the reference may be relied upon for all it teaches. Applicants’ further argue that Ritter discloses nothing about parking or dismantled connectors, and does not disclose the flushing connectors 22 and 23 are used to store the connectors/hose segments after a treatment when not is use. However, as discussed above, the claims do not make clear what is connected when things are “dismantled after treatment”, and more specifically the limitations to the parking stations are seen to be functional because they are described in terms of what they are for, and thus this is not seen to positively claim the inflow/outflow filter couplings actually being “parked” at the parking stations, but merely having parking stations that can function this way, similarly the prior art need not disclose that the parking stations are used in the functional way claimed, but merely that the prior art must have structure capable of being used in the way claimed, where the prior art is seen to have structure that can be used as a parking station during storage, as claimed. Claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function (see MPEP 2114).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Eric J. McCullough whose telephone number is (571)272-8885. The examiner can normally be reached Monday-Friday 10:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin L Lebron can be reached at 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J MCCULLOUGH/ Examiner, Art Unit 1773
/BENJAMIN L LEBRON/ Supervisory Patent Examiner, Art Unit 1773