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 filed 3/18/24 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
No copies of the foreign documents of the NPL have been received.
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) 1-11 and 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falkville et al. US 6,299,769.
Claim 1, Falkville teaches a disposable arrangement comprising: at least one fluid conducting device (28) capable of defining a flow circuit that extends through a blood chamber of a dialyzer and comprises connectors including a first and second connector (22 and at 20) for connection to system and a sterilizing filter (located within 27), the disposable arrangement is capable of defining a flow circuit to form a closed loop that includes the sterilizing filter fluidly coupled to the second connector (fig. 1-2). The recitation of the arrangement being for use with a blood treatment apparatus is a recitation of intended use and does not provide any further structural limitations to the apparatus. Additionally, the recitation of the fluid conducting device being “configurable to define a flow circuit that extends through a blood chamber of a dialyzer” and having connectors “for connection to a vascular system of a subject during a blood treatment” and being “configurable to define a flow circuit to form a closed loop that includes the sterilizing filter” are each recitations of intended use that do not provide further structural limitations to the apparatus. The recitation of the closed loop is formed for priming the flow circuit before the blood treatment using a human compatible fluid is a recitation of an intended use for the closed loop, which was also an intended use of the arrangement and therefore does not provide any further structural limitations to the claimed apparatus. The prior art need only be capable of being arranged as claimed to meet the limitations of the claim.
Claim 13, Falkville teaches a disposable arrangement comprising: at least one fluid conducting device (28) capable of defining a flow circuit that extends through a blood chamber of a dialyzer and comprises connectors including a first connector and a second connector (22 and at 20) for connection to system and a sterilizing filter (the sterilizing filter will inherently be located within a container at 27), the container fluidly connected to the fluid conducting device and the sterilizing filter being fluidly connected to the fluid conducting device and the fluid container via the second connector, the disposable arrangement is capable of defining a flow circuit to form a closed loop that includes the sterilizing filter (fig. 1-2). The recitation of the arrangement being for use with a blood treatment apparatus is a recitation of intended use and does not provide any further structural limitations to the apparatus. Additionally, the recitation of the fluid conducting device being “configurable to define a flow circuit that extends through a blood chamber of a dialyzer” and having connectors “for connection to a vascular system of a subject during a blood treatment” and being “configurable to define a flow circuit to form a closed loop that includes the sterilizing filter” are each recitations of intended use that do not provide further structural limitations to the apparatus. The recitation of the closed loop is formed for priming the flow circuit before the blood treatment using a human compatible fluid is a recitation of an intended use for the closed loop, which was also an intended use of the arrangement and therefore does not provide any further structural limitations to the claimed apparatus. The prior art need only be capable of being arranged as claimed to meet the limitations of the claim.
Claims 2-6 and 14-17, Falkville further teaches a container (the sterilizing filter will inherently be located within a container at 27) the container is capable of defining a flow circuit to include the container (fig. 1-2); the container comprises an inlet port and outlet port and the disposable arrangement is further able to include the container in the closed loop by connection of the connectors to the inlet and outlet ports (fig. 1-2); the sterilizing filter is capable of being co-located with the outlet port so that fluid flows through the sterilizing filter when leaving the container via the outlet port (fig. 1-2); the sterilizing filter is capable of being located intermediate the container and one of the connectors (fig. 1-2); and the sterilizing filter is arranged inside the container (fig. 1-2).
Claims 7 and 18, Falkville further teaches a dialyzer (14) (fig. 1). One of ordinary skill in the art would immediately recognize that a dialyzer will inherently comprise a fluid chamber, blood chamber and a semi-permeable membrane separating the fluid and blood chambers and the fluid chamber would be configured for connection to a fluid supply unit.
Claims 8-11 and 19-20, Falkville further teaches the disposable arrangement is sterilized and located within a protective casing (col. 2, lines 24-46); the sterilizing filter is a sterilizing grade filter which is configured for bacterial retention (col. 1, lines 43-64); the at least one fluid conducting device includes at least two line sets (28 and between 22 and 27) (fig. 2); and a first line set includes a drip chamber (20) and the second line set includes a pump (30) (fig. 2).
Response to Arguments
Applicant's arguments filed 8/18/26 have been fully considered but they are not persuasive.
Applicant argues that in contrast to claim 1 Falkvall discloses a sterile filter placed along a hose that branches to a blood circuit for hemodiafiltration and that Falkvall fails to disclose a flow circuit that forms a closed loop that includes a sterilizing filter fluidly coupled to a second connector. The claim recites, “the disposable arrangement is configurable to define a flow circuit to form a closed loop that includes the sterilizing filter fluidly coupled to the second connector” (emphasis added). The claim requires the arrangement to be configurable to form the closed loop but does not actually require a flow circuit that forms a closed loop that includes the sterilizing filter fluidly coupled to the second connector. The prior art need only be capable/configurable to define a flow circuit as recited. The arrangement of Falkvall is capable of being arranged as claimed and therefore meets the limitations of the claim. Applicant argues that Falkvall does not contemplate priming and does not consider fluidly connecting a sterilizing filter to a second connector for forming a fluid loop for priming. The claim recites, “wherein the closed loop is formed for priming the flow circuit before the blood treatment using a human-compatible fluid.” (emphasis added). Again, the closed loop is a recitation of an intended use, and the intended use of the closed loop is for priming, which is also an intended use. The claim does not require priming but merely requires the arrangement to be capable/configurable for priming. The arrangement of Falkvall is capable of being arranged as claimed and therefore meets the limitations of the claim.
Conclusion
THIS ACTION IS MADE FINAL. 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 BENJAMIN M KURTZ whose telephone number is (571)272-8211. The examiner can normally be reached Monday-Friday 8:30-5.
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/BENJAMIN M KURTZ/Primary Examiner, Art Unit 1779
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