DETAILED ACTION
This action is in response to the RCE with amendments and remarks filed 06/25/2026, in which claims 1 is pending and claim 1 having been amended.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/25/2026 has been entered.
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.
Claim 1 is 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 limitation “the machine inflow parking station parking the dialyzer outlet coupling and storing the dialyzer outlet coupling such that the dialyzer outlet coupling is only fluidly connected to the machine through the machine inflow connection line” and “the machine outflow parking station parking the dialyzer inlet coupling and storing the dialyzer inlet coupling such that the dialyzer inlet coupling is only fluidly connected to the machine through the machine outflow connection line”. It is not clear if “parking” and “storing” are descriptions of its capability or meant to describe the physical arrangement of the parking stations and couplings. It is suggested that if it is not meant to be functional language they be amended to recite that the parking stations are physically supporting and directly attached to the couplings.
The term “direct proximity” in claim 1 is a relative term which renders the claim indefinite. The term “arranged together, in direct proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. This is specifically confusing as it is not clear what distance would be considered to be in “direct proximity”; for purposes of compact prosecution it will be interpreted that “direct proximity” means on the same side of the machine. It is suggested that if it is meant to require specific distance or direct physical contact then the claims should be amended to clarify this.
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 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 1 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2019/0001041 A1 (hereinafter “Ritter”) in view of US 2,761,469 (hereinafter “Hansen”).
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:
a dialyzer 2 held in the dialyzer holder 26, and comprising a dialyzer inlet 28, and a dialyzer outlet 30, and
two hydraulic connectors (treatment liquid connectors 20 and 21) at the dialysate side, the two hydraulic connectors comprising a machine outflow connector 20 for feeding fresh dialysis liquid to the dialyzer inlet 28, and a machine inflow connector 21 for draining consumed dialysate from the dialyzer outlet 30,
a machine inflow connection line 29 and a dialyzer outlet coupling (quick disconnect 36 on the end of line 29), the machine inflow connection line having a first end connected to the machine inflow connector and a second end connected to the dialyzer outlet coupling,
a machine outflow connection line 27 and an dialyzer inlet coupling (quick disconnect 36 on the end of line 27), the machine outflow connection line having a first end connected to the machine outflow connector and a second end connected to the dialyzer inlet coupling,
a machine inflow parking station (considered to be flushing connector 23) associated with the machine inflow connector (seen to be the quick disconnect 36 on hose segment 29),
a machine outflow parking station (considered to be flushing connector 22) associated with the machine outflow connector (seen to be the quick disconnect 36 on hose segment 27), (see Figs. 12-13, [0049]-[0054], [0058]),
wherein
the dialyzer inlet 28 and the machine inflow parking station 23 are arranged spaced apart from one another by a first distance, the machine inflow connection line 29 has a length that is less than the first 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], and where the inlet 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.),
the dialyzer outlet 30 and the machine outflow parking station 22 are arranged spaced apart from one another by a second distance, the machine outflow connection line 27 has a length that is less than the second 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], 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.).
PNG
media_image1.png
288
504
media_image1.png
Greyscale
Ritter it not seen to disclose “the machine inflow parking station parking the dialyzer outlet coupling and storing the dialyzer outlet coupling such that the dialyzer outlet coupling is only fluidly connected to the machine through the machine inflow connection line”, “wherein the machine inflow connector and the machine inflow parking station are arranged together, in direct proximity, at a first position of the dialysis machine”, “the machine outflow parking station parking the dialyzer inlet coupling and storing the dialyzer inlet coupling such that the dialyzer inlet coupling is only fluidly connected to the machine through the machine outflow connection line”, “wherein the machine outflow connector and the machine outflow parking station, are arranged together, in direct proximity, at a second position of the dialysis machine”.
However Ritter discloses “[a]t least one or all of the connectors can be provided in the form of quick-release couplings, for example in the form of a Hansen connector or a Luer-lock connector” and “[a]ccording to a particularly advantageous embodiment, the connectors each have a coupling with automatic closure, so that the internal fluidic system is sealed without leakage and protected against soiling when the filter element is not connected and unwanted leakage of treatment liquid can be avoided” [0012]. Further Hansen discloses a Hansen connector which has an automatic closure so fluid does not escape when it is not fully connected (see. Figs. 1-5, C1/L55-C3/L6).
Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the dialysis machine of Ritter such that all fluid connectors are the Hansen connectors as disclosed by Hansen because Ritter explicitly discloses such Hansen connectors with shutoff may be used for the fluid connectors of their device, and thus the invoels the simple substitution of Hansen connectors with automatic shutoff when they are disconnected.
Thus, as can be seen in the Figures of Hansen, the connectors have a male connector that goes inside of a female connector, and only when fully inserted do they fluidly communicate with each other, but they may be inserted partially such that they physically support each other without fluid flow. Therefore, the connectors may be parked or stored together without fluid flow.
With specific regard to the limitations: “the machine inflow parking station parking the dialyzer outlet coupling and storing the dialyzer outlet coupling such that the dialyzer outlet coupling is only fluidly connected to the machine through the machine inflow connection line”, “wherein the machine inflow connector and the machine inflow parking station are arranged together, in direct proximity, at a first position of the dialysis machine”, “the machine outflow parking station parking the dialyzer inlet coupling and storing the dialyzer inlet coupling such that the dialyzer inlet coupling is only fluidly connected to the machine through the machine outflow connection line”, “wherein the machine outflow connector and the machine outflow parking station, are arranged together, in direct proximity, at a second position of the dialysis machine”, it is first not clear whether “parking” is a functional limitation or is meant to imply specific physical arrangement, similarly it is not clear if the limaitons that wherein the machine inflow/outflow connector and the machine inflow/outflow parking station are arranged together, in direct proximity, at a first position of the dialysis machine require the respective connectors and parking stations to be actually touching or the parking station to be supporting the connectors, as “arranged together, in direct proximity” is not seen to sepficially limit how closely they must be arranged.
Thus, the limaitons may be seen as (i) functional, i.e. the respective connectors and parking stations must merely be capable of being “parked” together, or (ii) the respective connectors and parking stations must be in physical contact.
With regard to (i), for functional limitations the prior art need only disclose structure capable of achieving the recited function(s) to read on the functional limitations, see MPEP 2114. 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 in view of Hansen 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 quick release couplings of the flushing connectors 22 and 23 when not in use.
Alternatively, with regard to (ii) Ritter does not specifically disclose that the dialyzer outlet coupling is parked or stored on the machine inflow parking station (flushing connector 23) such that the dialyzer outlet coupling is only fluidly connected to the machine through the machine inflow connection line, or the dialyzer inlet coupling is parked or stored on the machine outflow parking station (flushing connector 22) such that the dialyzer inlet coupling is only fluidly connected to the machine through the machine outflow connection line, as they are only disclosed to be attached for fluid flow.
However, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the dialysis machine of Ritter in view of Hansen such that the dialyzer outlet coupling QR is attached (i.e. parked or stored) on the machine inflow parking station QR (flushing connector 23) in a partially inserted state such that they are not fluidly connected, and the dialyzer inlet coupling QR is attached (i.e. parked or stored) on the machine outflow parking station QR (flushing connector 22) in a partially inserted state such that they are not fluidly connected, because this would have been a common mistake when setting up the connections, or in order to stage the connections lines before connecting, or as a readily available and convenient place to hang the connectors to keep them out of the way.
Thus resulting in: the machine inflow parking station parking the dialyzer outlet coupling and storing the dialyzer outlet coupling such that the dialyzer outlet coupling is only fluidly connected to the machine through the machine inflow connection line, wherein the machine inflow connector and the machine inflow parking station are arranged together, in direct proximity, at a first position of the dialysis machine, the machine outflow parking station parking the dialyzer inlet coupling and storing the dialyzer inlet coupling such that the dialyzer inlet coupling is only fluidly connected to the machine through the machine outflow connection line, wherein the machine outflow connector and the machine outflow parking station, are arranged together, in direct proximity, at a second position of the dialysis machine as claimed.
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered but they are not persuasive.
In response to Applicants’ argument that because Ritter discloses “the connectors may be firmly integrated in a housing of the device, in particular a housing front” then it would be impossible to park the connectors at the parking stations; the Examiner disagrees. Ritter clearly discloses lines 27 and 29 have connectors on their ends, and thus those connectors could not be integrated in the housing as they could then not be switched between the dialyzer and the flushing ports, further this is an optional embodiment and thus is not limiting. Specifically the coupling on the end of the lines 27 and 29 would have either a male or female quick release connector/coupling, and those on the housing and dialyzer would have the other of the male or female, i.e. so they can be readily moved and connected as disclosed by Ritter.
In response to Applicants’ argument (from the remarks dated 11/07/2025) 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. 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 fluidly connected when things are “parked” or in “storage”.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC J MCCULLOUGH/ Examiner, Art Unit 1773
/BENJAMIN L LEBRON/ Supervisory Patent Examiner, Art Unit 1773
Prosecution Insights