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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 01/26/2026. Claims 1-20 are currently pending and being examined.
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.
Election/Restrictions
Claims 8-10 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/26/2026.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 recites “is automated peritoneal dialysis” in line 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “is an automated peritoneal dialysis”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Claim 12 recites “is automated peritoneal dialysis” in line 1 & 2. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “is an automated peritoneal dialysis”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 6, 11-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Folden (USPN 5,336,173).
In response to independent claim 1, Folden discloses a system for adapting use of dialysis solution bags (72, fig 1) between modalities of dialysis treatment (between CCPD and CAPD, col 1, lines 13-18 discloses “the invention is directed at an extremely efficient and easy to use tubing set for Continuous Ambulatory Peritoneal Dialysis ("CAPD") and Continuous Cycling Peritoneal Dialysis ("CCPD") and a method of operating the same”), comprising:
an adaptor assembly (tubing set 10 in fig 1) adapted for coupling a dialysis solution bag (72) for a first modality (CCPD, 20 fig 1) of dialysis treatment to a disposable set (60) configured for connection to a patient for a second modality (CAPD, 60 fig 1) of dialysis treatment (the abstract discloses “The tubing set includes elements for administering CCPD as well as elements for administering CAPD wherein preferably the CCPD and CAPD elements share a common reservoir bag and solution bags.”), wherein fluid flow from the dialysis solution bag (72) is controlled by the adaptor assembly (10) for use with the second modality (CAPD) of dialysis treatment (col 2, lines 66 discloses “After the patient has completed the nighttime CCPD portion of the therapy, the patient disconnects from the tubing set. The cycler then automatically fills the reservoir bag with a final dose of solution. The patient then disconnects the CAPD portion of the tubing set from the CCPD portion of the tubing set. The CAPD portion of the tubing set then becomes the mid-day exchange dose and set.”).
In response to independent claim 11, Folden discloses a method for adapting use of a dialysis solution bag (72, fig 1) between modalities of dialysis treatment (between CCPD and CAPD, col 1, lines 13-18 discloses “the invention is directed at an extremely efficient and easy to use tubing set for Continuous Ambulatory Peritoneal Dialysis ("CAPD") and Continuous Cycling Peritoneal Dialysis ("CCPD") and a method of operating the same”), comprising:
providing a dialysis solution bag (72) for a first modality of dialysis treatment (the abstract discloses “The tubing set includes elements for administering CCPD as well as elements for administering CAPD wherein preferably the CCPD and CAPD elements share a common reservoir bag and solution bags.”); coupling the dialysis solution bag (72) to a disposable set (60) for a second modality (CAPD) of dialysis treatment via an adaptor assembly (col 2, lines 66 discloses “After the patient has completed the nighttime CCPD portion of the therapy, the patient disconnects from the tubing set. The cycler then automatically fills the reservoir bag with a final dose of solution. The patient then disconnects the CAPD portion of the tubing set from the CCPD portion of the tubing set. The CAPD portion of the tubing set then becomes the mid-day exchange dose and set.”); controlling flow of fluid from the dialysis solution bag (72) via the adaptor assembly (10) in a manner suitable for use with the second modality of dialysis treatment (described above the set transforms from a night time CCPD system to a day time ambulatory/manual system).
In response to dependent claim 2, Folden discloses the system according to claim 1, wherein the first modality of dialysis treatment (CCPD, 20 fig 1) is automated peritoneal dialysis (APD) (done at night called CCPD) and the dialysis solution bag (72) is an APD solution bag (the abstract discloses “the CCPD and CAPD elements share a common reservoir bag and solution bags”), and wherein the second modality (CAPD) of dialysis treatment is a manual exchange treatment (done during the day disconnected from the machine) and the disposable set (60) is a manual exchange disposable set (set 60 is designed to be ambulatory with the patient).
In response to dependent claim 3, Folden discloses the system according to claim 2, wherein the adaptor assembly (10, fig 1) includes a manual exchange solution (78) bag acting as a reservoir fill bag and is coupled to the APD solution bag (72) via a connection adaptor device (connections in fig 1 that link 78 to 72).
In response to dependent claim 4, Folden discloses the system according to claim 2, wherein the adaptor assembly (10) includes a flow limiter device (36 & 86) (36 & 86) that limits fluid flow to the manual exchange disposable set (36 & 86).
In response to dependent claim 6, Folden discloses the system according to claim 4, wherein the flow limiter device includes a clamping mechanism (36 & 86) that engages to stop fluid flow (36 & 86 engage to stop fluid flow).
In response to dependent claim 12, Folden discloses the method according to claim 11, wherein the first modality of dialysis treatment is automated peritoneal dialysis (APD) (done with 20) and the dialysis solution bag (72) is an APD solution bag, and wherein the second modality of dialysis treatment (using 60) is a manual exchange treatment (it is “manual” because it is done without a machine) and the disposable set (60) is a manual exchange disposable set (set 60 is designed to be ambulatory with the patient).
In response to dependent claim 13, Folden discloses the method according to claim 12, wherein the adaptor assembly (10, fig 1) includes a manual exchange solution bag (78) acting as a reservoir fill bag and is coupled to the APD solution bag (72) via a connection adaptor device (connections in fig 1).
In response to dependent claim 14, Folden discloses the method according to claim 12, wherein the adaptor assembly includes a flow limiter device (36 & 86) that limits fluid flow to the manual exchange disposable set (in the drainage configuration 36 and 86 act as flow limiters).
In response to dependent claim 16, Folden discloses the method according to claim 14, wherein the flow limiter device includes a clamping mechanism that engages to stop fluid flow (clamps 36 & 86 engage to stop fluid flow).
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Folden (USPN 5,336,173) in view of Marra (EP 4091647)
In response to dependent claim 5, Folden discloses the system according to claim 4, however
Folden does not teach the flow limiter device includes an impeller that delivers a controlled amount of fluid to the manual exchange disposable set.
Marra, a similar dialysis fluid path, teaches the flow limiter device (the cassette 200, fig 1) includes an impeller (pictured in 200 of fig 1) that delivers a controlled amount of fluid to the set (para 0045 discloses “Each rotation of a rotor pump can contain a defined volume of fluid”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the flow control method taught in Marra in the system of Folden to provide “precise and/or accurate volumetric control” para 0045, Mara.
In response to dependent claim 15, Folden discloses the method according to claim 14, however
Folden does not teach the flow limiter device includes an impeller that delivers a controlled amount of fluid to the manual exchange disposable set.
Marra, a similar dialysis fluid path, teaches the flow limiter device (the cassette 200, fig 1) includes an impeller (pictured in 200 of fig 1) that delivers a controlled amount of fluid to the set (para 0045 discloses “Each rotation of a rotor pump can contain a defined volume of fluid”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the flow control method taught in Marra in the system of Folden to provide “precise and/or accurate volumetric control” para 0045, Mara.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Folden (USPN 5,336,173) in view of Gassman (USPAP 2023/0032772).
In response to dependent claim 7, Folden discloses the system according to claim 6, however
Folden does not teach the clamping mechanism includes a spring-loaded clamping mechanism.
Gassman, a similar dialysis system, teaches a clamping mechanism includes a spring-loaded clamping mechanism (para 0093 discloses “lines 14 and 16 also include line clamps 18a and 18v, which can be spring-loaded”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the spring clamps of Gassman in the system of Folden to provide a “fail-safe mechanical pinch clamps” para 0093, Gassman.
In response to dependent claim 17, Folden discloses the method according to claim 16, however
Folden does not teach the clamping mechanism includes a spring-loaded clamping mechanism.
Gassman, a similar dialysis system, teaches a clamping mechanism includes a spring-loaded clamping mechanism (para 0093 discloses “lines 14 and 16 also include line clamps 18a and 18v, which can be spring-loaded”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the spring clamps of Gassman in the system of Folden to provide a “fail-safe mechanical pinch clamps” para 0093, Gassman.
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lo (USPAP 2010/0217179) discloses a dialysis set.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783