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
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 39 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Caleffi et al. (US 2010/0280430).
With respect to Claim 54, Caleffi teaches a disposable set for an extracorporeal blood treatment apparatus (figure 4, paragraphs [0044] - [0046]), the disposable set (numerals 1 and 23, paragraphs [0022] and [0026]) comprising:
- a filtration unit (14);
- a blood circuit (23) comprising:
- a blood withdrawal line (15) extending between a first end connected to the filtration unit and a second end (see figure 4);
- a blood return line (16) extending between a first end connected to the
filtration unit and a second end;
the blood withdrawal line including a blood pump tract (around pump 17) configured to be engaged by a blood pump (17) of the extracorporeal blood treatment apparatus which is configured to determine a blood flow, at least during an operating condition, an access negative pressure is experienced upstream said blood pump tract, said blood flow in the blood circuit being in a direction from the blood withdrawal line towards the filtration unit and from the filtration unit through the blood return line (figure 4);
an infusion line (4) extending between a first end connected to the blood circuit
(see figures 1-4) at a fluid access, and in particular to the blood withdrawal line,
upstream the blood pump tract, and a second end for connection to an infusion
substance source (2), wherein the blood pump tract is interposed between the
second end of the blood return line, in particular the filtration unit, and the first
end of the infusion line (see figure 4);
the disposable set further comprises a pressure damper (valve 6 and expansion
chamber 9), arranged proximate or at the first end of the infusion line (see
figures 1-4), the pressure damper being configured to prevent, or reduce an
amount of, the access negative pressure to extend in the infusion line upstream
the pressure damper (when closed, the valve 6 will prevent negative pressure from transferring into the line, and the expansion chamber 9 will further prevent transfer; Figure 4 and paragraphs [0028-0035]).
Allowable Subject Matter
Claims 40-54 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.
Claims 53-74 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
the prior art does not teach or suggest a disposable cassette having an infusion line with a pressure damper as claimed.
With respect to Claims 40-52 and 69-72, the prior art does not teach or suggest that the damper comprises a one way valve preset at an opening pressure threshold to switch between the closed position and the open position and vice versa, so that when a differential pressure between an upstream section and a downstream section of the one-way valve is equal or higher than said opening pressure threshold, the one-way valve is configured to switch to or to maintain the open position, and when said differential pressure is lower than said opening pressure threshold, the one-way valve is configured to switch to or to maintain the closed position
With respect to Claims 53-64, the prior art does not teach or suggest that the damper comprises a deformable flow passage comprising deformable a flow passage restrictor is configurable between a rest condition in which the deformable flow passage restrictor has a damper lumen which is closed to prevent fluid flow or which defines a damper passage section for the infusion fluid having a size lower than 1 square millimeter, an infusion condition in which a lumen pressure inside the deformable flow passage restrictor is above a predefined threshold, the damper lumen of the deformable flow passage restrictor is configured to open to allow transit of the infusion fluid.
With respect to Claims 65-68, the prior art does not teach or suggest that the pressure damper is a flow passage restrictor, the flow passage restrictor having a damper passage section configured to allow the infusion fluid to pass through, and the infusion line having a respective fluid passage section configured to allow the infusion fluid to pass through, wherein the damper passage section is at least 50% smaller than the fluid passage section.
Claims 41-52, 54-64, 66-68, and 70-74 depend from a claim that is allowable or contains allowable subject matter.
The closest prior art is Caleffi (US 2010/0280430), which teaches an infusion apparatus 1 for an extracorporeal system, the infusion apparatus having a pressure damper (6 and 9). Caleffi, however, uses an electronic controller to keep the valve in the open position, and closes the valve only when pressure detected in expansion chamber 9 falls outside of a predetermined range (paragraphs [0028-0035]. Accordingly, Caleffi fails to teach or suggest any of the structural specifics discussed above with respect to Claims 40, 53, 65, and 69.
Etzdorf (US 2017/0340796) also teaches an extracorporeal circuit with an infusion line 209 on the return line 205 of the blood flowpath, the infusion line having a one-way valve that functions as a pressure damper (Figure 2). However, Etzdorf’s valve is configured to open and close at different pressures, thereby maintaining a consistent pulsatile flow of fluid from chamber 319 (see the opening and closing pressures in Figure 3; paragraphs [0065-0074]). Etzdorf therefore fails to teach or suggest that the valve works as described in claims 40 and 69. Etzdorf also fails to teach or suggest the structural specifics of claims 53, and 65 discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781
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