17797140DETAILED 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/14/2025 has been entered.
Response to Amendment
The amendments filed on 05/16/2025 has been entered. Claims 1, 3-6, 12-14, and 16-17 have been amended; claims 2, 4, 9, 11, and 17 have been cancelled. Accordingly, claims 1, 3, 5-8, 10, and 12-16 are pending and under consideration.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 (from page 8 to 11) and its reference Malkin US 2020/0016038 A1 have been considered but are moot because the new ground of rejection does not rely the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Benk et al. US 20170296735 A1 (previously cited), as cited in the IDS, in view of Schuck et al. US 2020/0146932 A1 (newly cited), evidenced by Nijiland et al. US 2017/0002941 A1 (newly cited).
Applicant's arguments filed 11/14/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “the volume 6V of Benk is not a chamber adapted to contain the liquid but it is a - filter volume defined by the second filter element 6. As disclosed at par. [0043]: "The second filter insert 6 is like the first filter insert 4 is a screening filter and preferably has the same pore size as the first filter insert." The liquid contained into the volume 6V is capable of flowing out from its pores (par. [0048]: "A gas separation respectively takes place as the liquid flows through the filter walls 6' and 4") and, therefore, the volume 6V is not capable of containing the liquid but it is capable of filtering it” on page 7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Par. 43 of Benk discusses that “wherein the second filter wall 6′ of this second filter insert completely or partially encloses a second filter volume 6V”, thus containing the liquid flowing into volume 6V, even if it’s partially and/or momentarily.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5-8, 10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Benk et al. US 20170296735 A1 (previously cited, hereinafter Benk), as cited in the IDS, in view of Schuck et al. US 2020/0146932 A1 (newly cited, hereinafter Schuck), evidenced by Nijiland et al. US 2017/0002941 A1 (newly cited, hereinafter Nijiland).
Regarding claim 1, Benk discloses a device 1 (Fig. 1 – bag 1) for the priming of an extracorporeal circuit (Par. 2 – “the device particularly serves for filling a pump-operated, hollow line-supported liquid circuit with a liquid without forming gas bubbles”), the device 1 (Fig. 1) comprising:
- a bag 1 (Fig. 1) made of flexible material (Par. 35 – “the bag 1 has… elastic bag wall 1′ that has a biocompatible and elastically deformable plastic material”) and defining a containment volume 1V (Fig. 1 – inner bag volume 1V) of a liquid (Par. 35 – “…the inner bag volume 1V is also sealed in a fluid-tight manner”; thus indicating containing a fluid within);
- at least a first duct 8 (Fig. 1 – filling line 8) associated with said bag 1 (Fig. 1 – filling line 8 of bag 1) and provided with a first transit port (Fig. 1 – the lower end of filling line 8 that is inside the bag 1) placed inside said containment volume 1V (Fig. 1 – the lower end of filing line 8 is within the inner bag volume 1V) for the introduction of an operating liquid FK (Fig. 1 – liquid FK) inside the containment volume 1V (Fig. 1 shows a downward arrow as fluid flow of liquid FK from filling line 8 to the inner bag volume 1V; Par. 45 – “A filling line 8 is provided for filling the bag 1 with liquid…”);
- at least a second duct 3 (Fig. 1 – second hollow channel section 3) associated with said bag 1 (Fig. 1 – hollow channel section 3 of bag 1) and provided with a second transit port 31 (Fig. 1 – open channel end 31) placed inside said containment volume 1V (Fig. 1 – channel end 31 is within the inner bag volume 1V, and Par. 36 – “…hollow channel sections… 3 respectively provide open access to the inner bag volume 1V”) for the outflow of the operating liquid FK (Fig. 1) to the outside (Fig. 1 shows the downward arrow as fluid flow of liquid FK from the inner bag volume 1V and out of the channel section 3, and Par. 47 – “…the liquid FK flows… and reaches the pump-operated, hollow line-supported liquid circuit F through the second hollow channel section 3”);
- at least a third duct 2+5 (Fig. 1 – first hollow channel section 2 and fluid line section 5; during use, the fluid line section 5and hollow channel section 2 are coupled together – Par. 47 – “The filling process of the pump-operated, hollow line-supported liquid circuit F is carried out by initially producing a fluid-tight connection between the fluid line section 5 and the end 21 of the first hollow channel section 2”) associated with said bag 1 (Fig. 1 – channel section 2 and fluid line section 5 of bag 1) and provided with a third transit port 21 (Fig. 1 – open channel end 21) placed inside said containment volume 1V (Fig. 1 – channel end 21 is within the inner bag volume 1V) for the reintroduction of the operating liquid FK (Fig. 1) inside the containment volume 1V (Fig. 1 shows the upward arrow as fluid flow of liquid FK into the inner bag volume 1V through channel section 2);
- at least a fourth duct 7 (Fig. 1 – degassing line 7) associated with said bag 1 (Fig. 1 – degassing line of bag 1) and provided with a fourth transit port (Fig. 1 – the lower end of degassing line 7 that is inside bag 1) placed inside said containment volume 1V (Fig. 1 – the lower end of degassing line 7 is within the inner bag volume 1V) for the outflow to the outside of the air present in the containment volume itself 1V (Fig. 1) and in the operating liquid FK (Fig. 1 and Par. 45 – “the separated gas fractions can respectively escape or be removed by suction through the degassing line”); and
- valve means 6+ (Fig. 1 – second filter insert 6 and opening 6”) associated with said third duct 2+5 (Fig. 1 – third duct 2+5 is contained within the second filter insert 6), at the point where said third port 21 is located (Fig. 1 – second filter insert 6 are located at the upper end of the third port 21), and;
wherein said valve means 6+6” (Fig. 1) define at least one containment chamber 6V (Fig.1 – second filter volume 6V) of said third ports 21 (Fig. 1 – open channel end 21 leads into the second filter volume 6V in a coupled configuration), said containment chamber 6V (Fig. 1) being provided with at least one opening 6” (Fig. 1) adapted to allow the transit of the operating liquid FK (Fig. 1) flowing out of said third port 21 (Fig. 1) inside said containment volume 1V (Fig. 1, and Par. 38; opening 6” permits liquid FK to flow into the containment volume 1V from the open channel end 21), and
the operating liquid FK (Fig. 1) flowing of the third port 21 (Fig. 1) being initially contained inside the containment chamber 6V (Fig. 1 in a configuration where “ a fluid-tight connection between the fluid line section 5 and the end 21” (Par. 47), liquid FK enters open channel end 21 through the line section 5 and into volume 6V) defined by the valve means 6+6” (Fig. 1) and then flows out thereof through the opening 6” (Fig. 1, and Par. 44 – “The second filter insert 6 preferably has an opening 6″… wherein the liquid flow can reach the first filter volume 4V through the opening after a corresponding flow deviation”), thereby flowing inside the containment volume 1V (Fig. 1, and Par. 38 – “liquid in… a second filter volume 6V… reaching the bag volume 1V”).
However, Benk does not explicitly disclose one-way valve means adapted to prevent the transit of the operating liquid form said containment volume to said third duct, one closeable opening adapted to allow the transit of the operating liquid flowing out of said third port inside said containment volume but not vice versa, the closable opening having flaps approaching each other so as to close the closable opening, thus preventing the flow of the operating liquid, when the operating liquid is outside the containment chamber, while the flaps move away from each other, thus opening the closable opening so as to allow the flow of the operating liquid, when the operating liquid is contained inside the containment chamber, wherein the closable opening closes due to the presence of the operating liquid outside of the containment chamber, thus preventing the flow of the operating liquid,
the one-way valve means comprise at least two sheets made of a flexible material and sealed together along at least three sides contiguous to each other so as to define the containment chamber, through one of said three sides the third duct passes, where the non-sealed side of the sheets defines the closable opening.
Schuck, in the same field of endeavor of sterile product bag (Par. 3), teaches one-way valve means 402+406 (Fig. 30 – storage chamber 402 and one-way valve 406) adapted to prevent the transit of the operating liquid (Par. 144 – “a diluent or other medical fluid”) from said containment volume 402 (Fig. 30) to said third duct 156 (Fig. 30 – stem 156, and Par. 144 – “Finally, as shown, the concentrate storage chamber 402 includes a one-way valve 406, which upon exposure to a predetermined amount of pressure in the concentrate storage chamber 402 opens to allow flow of the reconstituted product from the concentrate storage chamber 402 to the sterile chamber 153”, which indicates one directionally flow of the product),
one closeable opening 406 (Fig. 30, and Par. 144 – “the one-way valve 406 can be… a duck bill valve”; Examiner notes that duckbill valve is well-known in the art to have an opening for fluid flow and can be closed as the lips come into contact, evidenced by Nijiland’s disclosure, e.g. Fig. 1A and Par. 42) adapted to allow the transit of the operating liquid (Par. 133 – “a diluent or other medical fluid”) flowing out of said third port 134 (Fig. 30 – duct 134) inside said containment volume 402 (Fig. 30, and Par. 144 – “a diluent can be supplied to the concentrate storage chamber 402 via the filtration device 155”) but not vice versa (Par. 144 and as discussed above – one directional flow out of duct 134), the closable opening 406 (Fig. 30) having flaps approaching each other (as established above and evidenced by Nijiland, the duckbill valve has flaps/lips that come into contact with each other) so as to close the closable opening 406 (Fig. 30 – the flaps/lips of duckbill valve 406 will close the opening), thus preventing the flow of the operating liquid (Par. 144 – “a one-way valve 406, which upon exposure to a predetermined amount of pressure in the concentrate storage chamber 402 opens”, which indicates the one-directional flow and the state of being closed when there is insufficient pressure), when the operating liquid is outside the containment chamber 402 (Fig. 30, and Par. 144 – one-way valve 406 only allows flow in one direction; evidenced by Par. 2 of Nijiland – “a duckbill which prevent backflow and allow forward flow only”), while the flaps move away from each other (Par. 144 – “a one-way valve 406, which upon exposure to a predetermined amount of pressure in the concentrate storage chamber 402 opens”, which indicates the flaps of duckbill valve 406 being separated), thus opening the closable opening 406 (Fig. 30, and Par. 144) so as to allow the flow of the operating liquid (Par. 144), when the operating liquid is contained inside the containment chamber 402 (Fig. 30), wherein the closable opening 406 (Fig. 30) closes due to the presence of the operating liquid outside of the containment chamber 402 (Fig. 30, and Par. 144), thus preventing the flow of the operating liquid (Par. 144, and evidenced by Par. 2 of Nijiland – “a duckbill which prevent backflow and allow forward flow only”)
the one-way valve means 402+406 (Fig. 30) comprise at least two sheets made of a flexible material (Par. 126 – “formed from two sheets of film that are heat sealed along their edges”) and sealed together along at least three sides contiguous to each other (Fig. 30 – chamber 402 is sealed at least three contiguous sides) so as to define the containment chamber 402 (Fig. 30), through one of said three sides the third duct 156 (Fig. 30) passes, where the non-sealed side of the sheets defines the closable opening 406 (Fig. 30 – the one-way valve 306 is arranged at the non-sealed side).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve means of Benk to one-way and made of two sheets sealed as taught by Schuck, in order to allow flow out of the containment chamber but not back into it (Par. 144 of Schuck). Furthermore, since Benk discussed that the filter insert 6 is like the filter insert 4 (Par. 43), wherein insert 4 is like the bag 1 itself (Par. 37), one of ordinary skill in the art would have been motivated to modify the valve means/insert 6 of Benk to become a bag type with two sheets as taught by Shuck.
Regarding claim 3, Benk in view of Schuck suggests the invention of claim 1. Benk in view of Schuck further discloses said one-way valve means 402+406 (Fig. 1 of Benk) defining said containment chamber 402 (Fig. 30 of Schuck) and said closable opening 406 (Fig. 30 of Schuck).
However, the combination does not currently disclose said one-way valve means are of the type of a bag and made of flexible material.
Benk, in another embodiment, teaches valve means (Par. 37 – filter insert) are of the type of a bag (Par. 37 – “the first filter insert is like the bag 1 itself designed in a bag-like or sack-like manner”) and made of flexible material (Par. 37 – “the first filter insert is like the bag 1 itself”, and Par. 35 – “the bag 1 has a light-transparent, elastic bag wall 1′ that has a biocompatible and elastically deformable plastic material”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the one-way valve means of Benk in view of Schuck to be a flexible bag type, also as taught by Benk, as Benk teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.).
Regarding claim 5, Benk in view of Schuck suggests the invention of claim 1. The combination further discloses wherein said closable opening 406 (Fig. 30 of Schuck) is substantially facing said third port 164 (Fig. 30 of Schuck).
Once the modification is made as discussed in claim 1, the closable opening 406 will be incorporated into the device of Benk, including its position of facing the third port as seen in Fig. 30 of Schuck.
Regarding claim 6, Benk in view of Schuck suggests the invention of claim 1. The combination further discloses further comprising: de-bubbling means 4 (Fig. 1 of Benk – first filter insert 4) of the air contained in the operating liquid FK (Fig. 1 of Benk) placed inside said containment volume 1V (Fig. 1 of Benk, and Par. 45 of Benk – “…the first filter insert 4, wherein the separated gas fractions can respectively escape or be removed by suction through the degassing line”).
Regarding claim 7, Benk in view of Schuck suggests the invention of claim 6. The combination further discloses wherein said de-bubbling means 4 (Fig. 1 of Benk) are placed around said one-way valve means 402+406 (Fig. 30 of Schuck – first filter insert 4 of Benk encloses the modified one-way valve means).
Regarding claim 8, Benk in view of Schuck suggests the invention of claim 7. The combination in further discloses wherein said de-bubbling means 4 (Fig. 1 of Benk) define a de-bubbling chamber 4V (Fig. 1 of Benk – first inner filter volume 4V), the walls 4’ (Fig. 1 of Benk – filter wall 4’, and Par. 37 – “…first filter wall 4′ that completely encloses the first filter volume 4V as illustrated in FIG. 1”) of which are permeable to air and liquids (Par. 43 of Benk – “The second filter insert 6 is like the first filter insert 4 is a screening filter and preferably has the same pore size as the first filter insert. The second filter insert 6 serves for reliably degassing fluid flows that contain gas and flow through the bag arrangement…”, while the cited disclosure regards to the second filter insert 6, it has the same composition as the first filter section 4; thus, the first filter section 4 is also permeable to both air and liquids as the second filter insert 6), said one-way valve means 402+406 (Fig. 30 of Schuck) and said fourth port 7 (Fig. 1 of Benk – the lower end of degassing line 7) being placed inside said de-bubbling chamber 4V (Fig. 1 of Benk – valve check 5’, modified insert 6/valve means 402+406 by Schuck, and degassing line 7 are positioned inside the filter volume 4V).
Regarding claim 10, Benk in view of Schuck suggests the invention of claim 1. The combination further discloses wherein said first duct 8 (Fig. 1 of Benk) is separate from said second duct 3 (Fig. 1 of Benk – filling line 8 and hollow channel section 3 are two distinct ducts).
Regarding claim 12, Benk discloses the invention of claim 1. Benk further discloses wherein said containment volume 1V (Fig. 1 of Benk) has a maximum cross-section (see annotated Fig. 1 of Benk below – maximum cross-section), transversely to the longitudinal extension of said at least a first duct 8, said at least a second duct 3, said at least a third duct 2+5, said at least a fourth duct 7 (see annotated Fig. 1 of Benk below – maximum cross-section is in a horizontal direction, which is perpendicular to the vertical/longitudinal axis of ducts 8, 3, 2+5, and 7), in the proximity of said closable opening 406 (Fig. 1 of Benk modified by Fig. 30 of Schuck).
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Annotated Fig. 1 of Benk
Regarding claim 13, Benk in view of Schuck suggests the invention of claim 1. The combination discloses said bag 1 (Fig. 1 of Benk) comprises at least a first lateral edge 1’ (Fig. 1 of Benk – bag wall 1’ on the left), delimiting at least part of said containment volume 1V (Fig. 1 of Benk – wall 1’ forms a border for bag volume 1V) and defining a concavity (see annotated Fig. 1 of Benk above – concavity) facing inwards from the containment volume 1V itself (see annotated Fig. 1 of Benk above – the concavity curves inward and into the bag volume 1V).
Regarding claim 14, Benk in view of Schuck suggests the invention of claim 13. The combination further discloses said first lateral edge 1’ (Fig. 1 of Benk – bag wall 1’ on the left) has an at least partly curved extension (see annotated Fig. 1 of Benk above – curved extensions on the upper and bottom corner of bag 1).
Regarding claim 15, Benk in view of Schuck suggests the invention of claim 1. The combination further discloses wherein said first duct 8 (Fig. 1 of Benk), second duct 3 (Fig. 1 of Benk) and third duct 2+5 (Fig. 1 of Benk) are placed, respectively, at a first zone 1o (Fig. 1 of Benk – upper bag edge 1o; filling line 8 is placed at the upper bag edge 1o), at a second zone “Z2” (see annotated Fig. 1 of Benk above – second zone “Z2”; hollow channel section 3 is placed at the second zone “Z2”) and at a third zone “Z3” (see annotated Fig. 1 of Benk above – third zone “Z3”; third duct 2+5 is placed at the third zone “Z3”) of said bag 1 (Fig. 1),
where said first zone 1o (Fig. 1 of Benk) is placed in the upper portion 1o of said bag 1 (Fig. 1 of Benk – upper edge 1o of bag 1) and where said second zone “Z2” and third zone “Z3” (see annotated Fig. 1 of Benk above) are placed in the lower portion 1u (Fig. 1 of Benk – lower bag edge 1u) of said bag 1 (see annotated Fig. 1 of Benk above – second zone “Z2” and third zone “Z3” are located in the lower bag edge 1u).
Regarding claim 16, Benk in view of Schuck suggests the invention of claim 13. The combination further discloses wherein said first lateral edge 1’ (Fig. 1 of Benk – bag wall 1’ on the right) connects said first zone 1o (Fig. 1 of Benk) to said third zone “Z3” (see annotated Fig. 1 of Benk above – bag wall 1’ on the right connects upper bag edge 1o to the third zone “Z3”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781