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 .
Response to Amendment
The amendments filed on 06/03/2026 have been entered. Claim 1 has 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 7 to 9) and its reference Schuck 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 2017/0296735 A1 (previously cited), as cited in the IDS, evidenced by Goldsmith US 2016/0273666 A1 (newly cited), as necessitated by amendment.
Applicant's arguments filed pm 06/03/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “This structure functions because the presence of operating liquid in the main containment volume (3) exerts pressure on the outside of the sheets, closing the opening (9a) and preventing backflow into the third duct (6). This is detailed in the specification at page 4, lines 18-22, which explains that the flaps close when liquid is outside the chamber (9)” on page 7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. Firstly, the details on Page 4, lines 18-22 as cited by Applicant, while providing support for claimed limitation in claim 1, do not actually describe any closing and opening of the flaps via pressure. In fact, the function of the flaps achieved by pressure mechanism is not discussed anywhere in the disclosure. Furthermore, according to MPEP 2114, “A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim”. In this instant case, even if the Examiner also considers Applicant’s alleged function based on pressure, the claimed structure is still disclosed by the modified device of Benk and the modified device of Benk also experiences the same physics-based exerted pressure (see rejection of claim below); thus, the device is capable of performing the claimed function.
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, evidenced by Goldsmith US 2016/0273666 A1 (newly cited, hereinafter Goldsmith).
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’+6’’ (Fig. 1 – second filter wall 6’ and opening 6”) associated with said third duct 2+5 (Fig. 1 – third duct 2+5 is contained within the second filter wall 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 port 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, Par. 29 – “the liquid only reaches the first filter volume after flowing through the second filter wall and/or through a corresponding opening within the second filter wall”, and Par. 38; opening 6” permits liquid FK to flow into the containment volume 1V from the open channel end 21), and
wherein said third port (Fig. 1) is arranged inside the containment chamber 6V (Fig. 1) defined by the valve means 6’+6’’ (Fig. 1).
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, Par. 29 – “the liquid only reaches the first filter volume after flowing through the second filter wall and/or through a corresponding opening within the second filter wall”, 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 and forms said flaps of the closable opening; and wherein the opening is substantially facing said third port.
Benk, in another embodiment, teaches the valve means (Par. 37 – filter insert) comprise at least two sheets made of a flexible material (Par. 37 – “the first filter insert is like the bag 1 itself designed in a bag-like or sack-like manner”) and sealed together along at least three sides contiguous to each other so as to define the containment chamber (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 valve means of Benk that currently has three contiguous walls and an opening on the fourth wall such that it made of two sheets of a flexible material, also as taught by Benk, in order to visually monitor the connections and gas separation of the device (Par. 14 and Par. 28 of Benk). Upon modification as discussed, the opening 6” would be reasonably understood to be formed from the unsealed portion of the two-sheet bag, “where the non-sealed side of the sheets defines the closable opening and forms said flaps of the closable opening”.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the position of the opening to so it was substantially facing the third port, since this claimed position of the opening does not change the its ability to allow fluid flow from the containment chamber to the containment volume. Since applicant has not given any criticality to why the position of the opening disclosed has any importance to the function of the claimed device, the Federal Circuit held that, where the only difference between the prior art and the claims was the position of a claimed element and altering the position of that claimed element would not have modified the operation of the device, the claimed device was not patentably distinct from the prior art device because it merely involved the rearrangement of parts. See MPEP 2144. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Once the modification is made as discussed, Examiner contends that the modified valve means of Benk is capable of performing the claimed functional language, as an inherent characteristic of Benk’s modified device. It has been established thus far that Benk discloses the claimed structures, and Benk also discloses that, “The liquid only reaches the first filter volume after flowing through the second filter wall and/or through a corresponding opening within the second filter wall, wherein the liquid then flows through the first filter wall and into the remaining bag volume, from which the liquid is returned to the hollow line-supported liquid circuit”, thus indicating a one-way, unidirectional flow of the liquid from the containment chamber 6V into the containment volume 1V. Thus, the limitation “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” is met. Furthermore, once all the liquid enters the main containment volume, one of ordinary skill in the art would have had the capability to recognize that the modified flaps also experience back pressure, which is highly capable of turning said present modified flaps of Benk into a type of duckbill valve. Goldsmith discusses that, “back pressure is a key part of the mechanism that closes a traditional duckbill valve. Without it, the duckbill may not close” (Par. 8). Therefore, the claimed functional language of “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” is inherently met by the physical phenomena. See MPEP 2114.I.
Regarding claim 3, Benk suggests the invention of claim 1. Benk further discloses said one-way valve means 6’+6” (Fig. 1 of Benk, upon modification) are of the type of a bag and made of flexible material (Par. 37) defining said containment chamber 6V (Fig. 1) and said closable opening 6” (Fig. 1 of Benk upon modification).
Regarding claim 5, Benk suggests the invention of claim 1. Benk further discloses wherein said closable opening 6” (Fig. 1 of Benk upon modification) is substantially facing said third port 21 (Fig. 1 of Benk upon modification).
Regarding claim 6, Benk suggests the invention of claim 1. Benk 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 suggests the invention of claim 6. Benk further discloses wherein said de-bubbling means 4 (Fig. 1 of Benk) are placed around said one-way valve means 6’+6” (Fig. 1 of Benk upon modification).
Regarding claim 8, Benk suggests the invention of claim 7. Benk 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 6’+6” (Fig. 1 of Benk) 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).
Regarding claim 10, Benk suggests the invention of claim 1. Benk 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 6’+6” (Fig. 1 of Benk upon modification).
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Annotated Fig. 1 of Benk
Regarding claim 13, Benk suggests the invention of claim 1. Benk 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 suggests the invention of claim 13. Benk 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 suggests the invention of claim 1. Benk 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 suggests the invention of claim 13. Benk 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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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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/QUYNH DAO LE/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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