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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 13-15) in the reply filed on 3/18/2026 is acknowledged.
Claims 6-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/18/2026.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over US 2008/0214981 A1 to Delnevo et al. (hereinafter “Delnevo”) in view of US Patent No. 7,686,778 B2 to Burbank et al. (hereinafter “Burbank ‘778”).
Regarding claim 1, Delnevo teaches a priming set (1) of a blood treatment device (see Figures 1-2; paragraphs [0022]-[0039]) comprising:
a drain bag 26 (Fig. 1: discharge in paragraph [0039]);
a bag spike (a spike at the end of supply line 21) constructed to connect to a medical fluid bag 24 (saline bag) having a predefined volume of fluid (Fig. 1; paragraph [0038]);
a first tube 2 (arterial line) having an inlet end and an outlet end, the first tube 2 being connected to the bag spike at the inlet end, the outlet end having a first blood treatment device connector 7 constructed to connect to a first blood port of the blood treatment device 4 (paragraph [0036]); and
a second tube 5 (venous line) connected to the drain bag 26 and having a second blood treatment device connector 11 constructed to connect to a second blood port of the blood treatment device 4 (see Fig. 1; paragraph [0036]).
Recitation of “a volume selected to ensure that the predefined volume of the fluid held by the medical fluid bag is more than the volume of blood and non-blood compartments of the blood treatment device plus the volume of the drain bag” is necessary for priming or removing air or gas from the blood treatment device. Delnevo teaches this recitation implicitly that the priming liquid flows from the priming liquid source to the blood treatment device, passing along the blood transport tube and fills the blood chamber of the blood treatment device and runs along the venous line up until it reaches the discharge and during the filling stage of the extracorporeal blood circuit with the priming liquid, the air contained in the circuit is expelled therefrom.
Claim 1 differs from Delnevo in reciting that the drain bag having elastic properties i.e. flexible drain bag.
Burbank ‘778 discloses a flexible drain bag 160 (see Figures 1-2; column 2, lines 7-12, 25-32).
It would have been obvious to a person of ordinary skill in the art to substitute a drain bag for flexible drain bag of Burbank ‘778 in the priming set of Delnevo for the benefit of holding expanded volume of drain fluid than its fixed volume.
Claim 3 differs from Delnevo in reciting that the drain bag is of inelastic film.
Burbank ‘778 discloses that a drain bag includes a soft layer and a stiff layer (a waste bag 160 comprising a rigid layer 110 (a stiff layer) i.e. inelastic film surrounding a flexible bag 120 (a soft layer); figure 1; column 2, lines 7-12, 24-27).
It would have been obvious to a person of ordinary skill in the art to substitute a drain bag for drain bag of inelastic film of Burbank ‘778 in the priming set of Delnevo for the benefit of
having a more rigid component combined with a more flexible component to improve durability.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Delnevo in view of Burbank ‘778 as applied to claim 1 above, and further in view of Canadian Patent No. 2,052,523 to Ebara et al. (hereinafter “Ebara”).
Delnevo in view of Burbank ‘778 discloses a priming set as described above.
Claim 2 differs from Delnevo in view of Burbank ‘778 in reciting that the drain bag is of nylon.
Ebara discloses a drain bag is of nylon (a collection container composition comprising polyamide (nylon); abstract; page 7, lines 6-10).
It would have been obvious to a person of ordinary skill in the art to substitute a drain bag for nylon drain bag of Ebara in the priming set of Delnevo in view of Burbank ‘778 for the benefit of achieving improved gas impermeability as suggested by Ebara (see page 4, lines 18-21).
Claims 4-5 and 13-15 rejected under 35 U.S.C. 103 as being unpatentable over Delnevo in view of Burbank ‘778 as applied to claim 1 or 3 above, and further in view of US 2012/0325696 A1 to Burbank et al. (hereinafter “Burbank '696”).
Delnevo in view of Burbank ‘778 discloses a priming set as described above.
Delnevo teaches a first tube (2) having a first sealing connector with a removable cap 19 composed of male and female halves (see Fig. 1; paragraph [0027]).
Claims 4 and 14 differ from Delnevo in view of Burbank ‘778 in reciting a first interconnector having no fluid path therethrough connected between male and female halves of a first self-sealing connector.
Burbank '696 discloses that a connector pair is connected to a removable interconnect member that fits each member of the pair such that self-sealing valves thereof remain closed (a valve system, as seen in figure 3, has the luer connector 442 that seals itself when disconnected from a mating connector 452, pinching to compress tube 474 such that the tube remains sealed when the connectors are disconnected (see figures 2A, 3; paragraphs [0035]-[0036]) and wherein the self-sealing valves include elastomeric material that is subject to material creep (the valve system, as seen in figure 3, has a deformable bendable ring (elastomeric material that is subject to material creep)(see figures 2A, 3; paragraphs [0035]-[0037]).
It would have been obvious to a person of ordinary skill in the art to have modified the priming set of Delnevo in view of Burbank ‘778 in order to provide a first interconnector having no fluid path therethrough connected between male and female halves of a first self-sealing connector such that self-sealing valves thereof remain closed and wherein the self-sealing valves include elastomeric material that is subject to material creep for the benefit of maintaining sterile and contaminant-free fluid circuit as suggested by Burbank ‘696.
. Delnevo teaches a second tube (5) having a second sealing connector with a removable cap composed of male and female halves (see Fig. 1; paragraph [0024]).
Claims 5, 13 and 15 differ from Delnevo in view of Burbank ‘778 in reciting a second interconnector having no fluid path therethrough connected between male and female halves of a second self-sealing connector.
Burbank '696 discloses that a connector pair is connected to a removable interconnect member that fits each member of the pair such that self-sealing valves thereof remain closed (a valve system, as seen in figure 3, has the luer connector 442 that seals itself when disconnected from a mating connector 452, pinching to compress tube 474 such that the tube remains sealed when the connectors are disconnected (see figures 2A, 3; paragraphs [0035]-[0036]) and wherein the self-sealing valves include elastomeric material that is subject to material creep (the valve system, as seen in figure 3, has a deformable bendable ring (elastomeric material that is subject to material creep) (see figures 2A, 3; paragraphs [0035]-[0037]).
It would have been obvious to a person of ordinary skill in the art to have modified the priming set of Delnevo in view of Burbank ‘778 in order to provide a second interconnector having no fluid path therethrough connected between male and female halves of a second self-sealing connector such that self-sealing valves thereof remain closed and wherein the self-sealing valves include elastomeric material that is subject to material creep for the benefit of maintaining sterile and contaminant-free fluid circuit as suggested by Burbank ‘696.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
4/5/26
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