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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 15-20) in the reply filed on 8/11/2026 is acknowledged.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/11/2026.
Claim Objections
Claims 15-19 are objected to because of the following informalities:
On line 3 of claim 15, “the hollow fiber membranes” should read “the plurality of hollow fiber membranes” to provide proper antecedent basis.
On line 3 of claim 16, “the inlet apertures” should read “the plurality of inlet apertures” to provide proper antecedent basis.
On line 3 of claim 17, “the capillary membranes” should read “the plurality of capillary membranes” to provide proper antecedent basis.
On line 1 of claim 18, “the hollow fiber membranes” should read “the plurality of hollow fiber membranes” to provide proper antecedent basis.
On line 2 of claim 19, “the hollow fiber membranes” should read “the plurality of hollow fiber membranes” to provide proper antecedent basis.
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.
Claim(s) 15-16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takesawa et al. (US 5,700,372; hereafter Takesawa).
In regard to claim 15, Takesawa discloses a filter set (1) comprising: a body (3) holding a plurality (4) of hollow fiber membranes (41) positioned and arranged such that fresh PD fluid flows through porous walls of the hollow fiber membranes (41) prior to exiting the body (functional limitation); a lumen-side connector (34) configured to connect to a patient line, the lumen-side connector (34) positioned to introduce fresh PD fluid to the body and to receive used PD fluid from the body (functional limitation); and (i) a transfer set-side connector (35) configured to connect to a patient's transfer set (functional limitation), or (ii) a flexible line (11B) configured to connect to the patient's transfer set.
In regard to claim 16, Takesawa discloses wherein the body (3) includes a fresh PD fluid passageway (lumen of 3) in fluid communication with a plurality of inlet apertures (36, 37) formed in a wall (wall of 3) of the body (3), the inlet apertures (36, 37) forming fresh PD fluid inlets to the plurality of hollow fiber membranes (see Fig. 2) (the limitations “fresh PD fluid passageway” are intended use limitation).
In regard to claim 17, Takesawa discloses a filter set (1) comprising: a body (3) holding a plurality (4) of capillary membranes (41) positioned and arranged such that fresh PD fluid flows through porous walls of the capillary membranes (41) prior to exiting the body; a lumen-side connector (34) configured to connect to a patient line, the lumen-side connector (34) positioned to introduce fresh PD fluid to the body (3) and to receive used PD fluid from the body (functional limitation); and a transfer set-side connector (35) configured to connect to a patient's transfer set, or wherein the filter set (1) includes a flexible line (11B) configured to connect to the patient's transfer set.
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 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.
Claim(s) 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Norman et al. (US 2020/0086028; hereafter Norman) in view of Peabody et al. (US 2002/0162778; hereafter Peabody).
In regard to claim 15, Norman discloses a filter set (100) comprising: a body (104) holding a plurality (4) of membranes (see par. [0097]; “first filter membrane” and “second filter membrane”) positioned and arranged such that fresh PD fluid flows through porous walls of the membranes (prior to exiting the body (see Fig. 3; see par. [0097]); a lumen-side connector (114) configured to connect to a patient line (50), the lumen-side connector (114) positioned to introduce fresh PD fluid to the body and to receive used PD fluid from the body (see Fig. 3 and par. [0097]); and (i) a transfer set-side connector (108) configured to connect to a patient's transfer set (see Fig. 3), or (ii) a flexible line (50) configured to connect to the patient's transfer set.
Norman fails to disclose that a plurality of hollow fiber membranes as is recited in claim 15.
In a similar art, Peabody discloses the use of a plurality of hollow fiber membranes (202) in a filter set body (200), wherein the membranes allow dialysis fluid to filter through the semipermeable walls of the capillary tubes (see par. [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the membranes of Norman with the hollow fibers of Peabody because the fibers perform the same function of filtering dialysis fluid and is suitable for the same intended purpose. Such a substitution represents the predictable use of a known alternative according to its established function.
In regard to claim 16, Norman discloses wherein the body (104) includes a fresh PD fluid passageway (120) in fluid communication with a plurality of inlet apertures (opening near 116 and opening near 150a) formed in a wall (wall of 104) of the body (104), the inlet apertures forming fresh PD fluid inlets to the plurality of hollow fiber membranes (see Fig. 3) (the limitations “fresh PD fluid passageway” are intended use limitation).
In regard to claim 17, please see the rejection of claim 15. The fiber membranes of Peabody are capillary tubes.
In regard to claim 18, Peabody teaches wherein the hollow fiber membranes (202) are closed on one end to force fresh PD fluid through their porous walls, the ends closed individually, or wherein at least two of the ends are closed via a common structure (closed via elements 204 and 206; see par. [0044]).
In regard to claim 19, Norman discloses which includes at least one hydrophobic membrane (152) positioned to vent air from the fresh PD fluid prior to reaching the hollow fiber membranes (see par. [0105]).
In regard to claim 20, Norman discloses which includes at least one net (body of 112) positioned to divert air towards the at least one hydrophobic membrane.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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