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 .
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) 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haight (US 6,758,971).
Regarding claim 16, Haight discloses a filter set 49 for connecting to a patient line, the filter set comprising: a filter housing 67, 69, 71 including a tubular filter membrane 59 positioned and arranged to filter fresh PD fluid flowing radially across the tubular filter membrane (col. 5, lines 54-60; fig. 2); a filtered fluid compartment 55 for receiving filtered fresh PD from the tubular filter membrane (fig. 2); and a transfer set-side port 51 positioned and arranged to receive filtered fresh PD fluid from the filtered fluid compartment during a patient fill and used PD fluid during a patient drain (col. 5, lines 40-42).
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) 1, 9-11, 13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haight in view of Norman et al (US 2020/0086028).
Regarding claim 1, Haight discloses a peritoneal dialysis system (col. 2, line 25) comprising: a filter set 49 including a filter housing 67, 69, 71 having a tubular filter membrane 59 positioned and arranged to filter fresh PD fluid flowing radially across the tubular filter membrane (fig. 2; col. 5, lines 54-60), and a transfer set-side port 51 positioned and arranged to receive (i) filtered fresh PD fluid during a patient fill and (ii) used PD fluid during a patient drain (fig. 2; col. 5, lines 40-42).
Claim 1 further calls for a PD machine; and a patient line extending from the PD machine. Haight discloses that the filter is for use in a PD system between a PD machine and a patient, but fails to explicitly disclose these elements. Norman teaches a PD system including a PD machine and a patient line extending from the PD machine to a filter 100 (page 6, para. 0079; page 7, para. 0085; fig. 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the filter of Haight to be used in combination with a PD system and patient line as taught by Norman to provide peritoneal dialysis to the patient in need thereof.
Regarding claim 9, Haight teaches at least one hydrophobic membrane (col. 6, lines 34-35) positioned and arranged to vent air from the fresh PD fluid upstream from the tubular filter membrane (col. 6, lines 28-35; fig. 5).
Regarding claim 10, Haight shows that the at least one hydrophobic membrane is positioned at least one end of the filter membrane (fig. 5). In the embodiment having the tubular filter membrane, it would have been obvious to place the hydrophobic membrane in the same location which would be at one end of the tubular filter membrane.
Claim 11 calls for the filter set to be configured such that fresh PD fluid is filtered through the tubular filter membrane inside-out. Haight discloses that the fresh PD fluid is filtered through the filter from the outside in (fig. 2). It would have been a mere reversal of parts to modify the arrangement of Haight so that the fresh PD fluid moves through the filter from the outside in. the filter would work equally well arranged either way. Such a modification is obvious per MPEP 2144.04(VI)(A). Additionally, this is the configuration taught by Norman (fig. 3).
Regarding claim 13, the limitations “is configured to connect directly to a patient's transfer set”, is interpreted to be an intended use limitation. Haight discloses that the filter set connects to a patient’s transfer set via connector 51 and therefore is capable of being connected either directly thereto or via a flexible tubing.
Regarding claim 15, Haight discloses that the tubular filter membrane is a sterilizing grade filter membrane or a bacteria reduction filter membrane (col. 2, lines 11-14).
Claim(s) 2-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haight in view of Norman as applied to claim 1 above, and further in view of Navis (US 6,659,134).
Claim 2 differs from Haight in view of Norman in calling for the patient line to be a dual lumen patient line including a fresh PD fluid lumen placed in fluid communication with a fresh PD fluid passageway of the filter set, the dual lumen patient line further including a used PD fluid lumen placed in fluid communication with a used PD fluid passageway of the filter set, the fresh PD fluid passageway positioned and arranged to deliver fresh PD fluid to the tubular filter membrane. Haight discloses that the filter set includes used PD fluid passageway 55, and a fresh PD fluid passageway 61, but fails to disclose the dual lumen patient line. Navis teaches a patient line for use in peritoneal dialysis wherein the patient line includes a fresh PD fluid lumen 12 (inflow conduit) and a used PD fluid lumen 14 (outflow conduit) which provides improved peritoneal dialysis that is suitable for continuous use, allowing simultaneous inflow and outflow (col. 1, lines 58- 60; col. 2, lines 64-65; figs. 1, 2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patient line of Norman to be a dual lumen patient line including a fresh PD fluid lumen and a used PD fluid lumen as taught by Navis to provide improved peritoneal dialysis by allowing continuous inflow and outflow. The resulting structure of this modification is the used PD fluid lumen in fluid communication with the used PD fluid tube.
Claim 3 calls for the fresh PD fluid passageway to be positioned and arranged to deliver fresh PD fluid to an interior of the tubular filter membrane. Haight discloses that the fresh fluid passageway 61 delivers the fresh PD into an exterior of the membrane at which point the fluid is filtered through the membrane to the transfer-set side port (fig. 2). It would have been a mere reversal of parts to modify the arrangement of Haight so that the fresh PD is delivered into the interior of the filter membrane and filtered through the membrane outwardly. Such a modification is obvious per MPEP 2144.04(VI)(A). Additionally, this is the configuration taught by Norman (fig. 3).
Regarding claim 4, Haight discloses a wall 67 forming a part of the filter housing (fig. 2), the wall including an inlet to the tubular filter membrane, the inlet in fluid communication with the fresh PD fluid passageway 61 (fig. 2).
Regarding claim 5, Haight discloses that the wall 67 includes an outlet through which used PD fluid flows to the used PD fluid passageway (fig. 2).
Regarding claim 6, Haight discloses the filter housing is configured such that used PD fluid flows across the tubular filter membrane 59 to the outlet 57 (fig. 2).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haight in view of Norman as applied to claim 1 above, and further in view of Connell et al (US 7,708,714).
Regarding claim 12 Haight discloses that the filter set to include includes a lumen-side connector connected to a patient line connector (fig. 2). Haight fails to disclose a gasket for sealing between the lumen- side connector and a patient line connector. Connell teaches a gasket to provide a secure fluid tight connection between a dialysis system and a transfer set (col. 5, lines 20-25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the connection of Haight to include a gasket as taught by Connell to provide a secure leak-free connection between the fluid elements.
Allowable Subject Matter
Claims 7, 8, 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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