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 .
Status of Claims
As directed by the amendment filed on 20 January 2026: claim(s) 1, 2, 4-7, and 18-20 have been amended.
Response to Arguments
Applicant's arguments filed 20 January 2026 have been fully considered but they are not persuasive.
Regarding the arguments that “the valve 1403 of Naygauz does not ‘comprise’ the first vessel 1401”, “Naygauz fails to teach or suggest a closing portion configured to be arranged on a rim of an open portion of the fluid line, the rim defining an opening of the open portion”, “the first vessel 1401 of Naygauz does not extend downward from the valve 1402 an at least partially receive and surround an open portion of a fluid line”, and “Naygauz fails to teach or suggest an intended breaking point”, the rejection discussions below addresses the amended claim limitations. Naygauz discloses or suggests all limitations.
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, 3-9, 13, 15-16, 18, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naygauz (US 20200315918 A1).
Regarding Claim 1, Naygauz discloses a closing element for a fluid line ("valve 1403" [0300]; FIGs. 14A & 14B) comprising:
a closing portion configured to be arranged on a rim of an open portion of the fluid line (see 1st Annotated FIG. 14A), the rim defining an opening of the open portion (see 1st Annotated FIG. 14A), the closing portion further configured to cover the opening to fluidically close the fluid line ([0289] & [0300] “valve 103 is shown in a closed configuration thus not allowing a fluid substance “S” to flow into and/or out of the syringe 101”; 1st Annotated FIG. 14A),
wherein the closing portion comprises an intended breaking point (the point where the internally protruding portions of valve 1403 meet each other; [0300]; 2nd Annotated FIG. 14A);
a main body that extends downward from the closing portion, the main body configured to at least partially receive and surround the open portion of the fluid line (see 1st Annotated FIG. 14A; ¶ [0300] FIGS. 14A-14B … Valve 1403 disposed such to extend from an internal position within tip 1411, via the side walls, to an external position in tip 1411 … Optionally, as demonstrated herein in FIG. 14B the valve 1403, or at least a portion thereof can be incorporated in the side walls of vessel 1401); and
a pressure receiving portion (Annotated FIGs. 14A) configured to receive pressure applied by a pressure exertion element ("second vessel 1402 includes a port 1406 with side walls that can connect tip 1411 in a manner that allows pushing the externally protruding portions of valve 1403, opening of the valve 1403 occurs" [0300]; FIG. 14B),
wherein the pressure receiving portion comprises at least one protrusion that is configured to come into contact with the pressure exertion element (see 2nd Annotated FIG. 14A).
1st Annotated FIG. 14A
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2nd Annotated FIG. 14A
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Regarding Claim 3, Naygauz discloses the closing portion comprises at least two plates that are separated from each other by the intended breaking point ([0300]; 2nd Annotated FIG. 14A).
Regarding Claim 4, Naygauz discloses the at least two plates are arranged at an angle relative to each other ([0300]; 2nd Annotated FIG. 14A).
Regarding Claim 5, Naygauz discloses the pressure receiving portion comprises a plurality of protrusions arranged along an outer circumference of the closing element ([0300]; 2nd Annotated FIG. 14A).
Regarding Claim 6, Naygauz discloses each protrusion of the plurality of protrusions is arranged on a respective plate of a plurality of plates forming the closing portion so that pressure applied to each protrusion is selectively transferred to the respective plate the protrusion is arranged on ([0300]; FIGs. 14A & 14B).
Regarding Claim 7, Naygauz discloses the pressure receiving portion and / or at least one protrusion thereof is present on at least half of a longitudinal length of the closing element in an insertion direction of the fluid line into the closing element ([0300]; FIGs. 14A & 14B).
Regarding Claim 8, Naygauz discloses the pressure receiving portion and / or at least one protrusion thereof at least partially defines a distal end face of the closing element in the insertion direction of the fluid line into the closing element ([0300]; FIGs. 14A & 14B).
Regarding Claim 9, Naygauz discloses the main body has a cylindrical or polygonal, form ("circular body" [0246]; FIG. 14A).
Regarding Claim 13, Naygauz discloses a connector comprising at least one fluid line providing a flow path through the connector, wherein the closing element according to claim 1 is arranged on at least one fluid line of the connector to fluidically close the fluid line ([0300]; FIG. 14A).
Regarding Claim 15, Naygauz discloses at least one of the fluid lines of the connector comprises a sharp or pointed leading edge pointing away from the connector (see FIG. 14A).
Regarding Claim 16, Naygauz discloses a system ("system 1400" [0300]; FIG. 14A) comprising the closing element according to claim 1, a connector, and a pressure exertion element, wherein the pressure exertion element is configured to be fluidically connected to the fluid line of the connector by breaking the intended breaking point of the closing element, by a relative movement of the pressure exertion element and the connector ([0300]; FIGs. 14A & 14B).
Regarding Claim 18, Naygauz discloses the fluid line is a fluid line of a concentrate container, and the connector is a connector element to be fluidically connected to the fluid line by breaking the intended breaking point, and the at least one protrusion projects outwards from the closing portion or the main body that is configured to come into contact with the connector element ([0300]; FIGs. 14A & 14B).
Regarding Claim 20, Naygauz discloses the at least one protrusion is a plurality of protrusions arranged along an outer circumference of the closing element at the pressure receiving portion thereof, wherein the plurality of protrusions are separate from another and / or arranged in equal intervals along the outer circumference ([0300]; FIG. 14A).
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.
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.
Claim(s) 2 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naygauz.
Regarding Claims 2 & 19, Naygauz discloses the pressure receiving portion comprises a protrusion running at least along a part of or along an entire length of an outer circumference of the closing element ([0300]; Annotated FIG. 14A) and the at least one protrusion is a protrusion running at least along a part of or along an entire length of an outer circumference of the closing element and the main body thereof ([0300]; 2nd Annotated FIG. 14A), but fails to specify the protrusion is annular. However, Naygauz teaches “Various forms of connecting structures/ports are herein contemplated” including “a circular body” ([0246]). The instant disclosure also do not place any criticality on the annular shape. Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Naygauz to incorporate the claimed shape as a matter of design choice. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim(s) 10-12, 14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naygauz in view of Biehl et al. (US 20150217104 A1).
Regarding Claims 10-12, 14, and 17, Naygauz fails to specify at a connection point between the closing portion comprising the intended breaking point and the main body of the closing element the material is selectively weakened, by providing at least one recess, to facilitate breaking of the intended breaking point due to pressure being applied to the pressure receiving portion; wherein the closing element is at least partially or completely manufactured from linear low density polyethylene and / or high density polyethylene; wherein the closing element is formed from at least two polymers, one of which preferably being easier to break than the other, the polymer being easier to break forming the intended breaking point; wherein the fluid line comprises only one lumen or an inner lumen and an outer lumen, wherein the closing element is arranged on an end face of the one lumen or the outer lumen and an end face of the inner lumen is arranged retracted into the outer lumen so that a gap is present between the end face of the inner lumen and the closing element; wherein the connector, that is a connector of a concentrate container, and / or the pressure exertion element, that is a connector element of a blood treatment device or a dosing unit thereof, comprises at least one fluid line comprising an inner lumen and an outer lumen arranged concentrically to each other. However, Biehl teaches a connector system for producing a connection between at least two fluid-conveying systems by means of a first connector and a second connector ([0001]) wherein at a connection point between the closing portion comprising the intended breaking point and the main body of the closing element the material is selectively weakened, by providing at least one recess ("partial area 20 that can be weakened by the action of a suitable medium" [0051]-[0057]), to facilitate breaking of the intended breaking point due to pressure being applied to the pressure receiving portion ([0051]-[0057]); wherein the closing element is at least partially or completely manufactured from linear low density polyethylene and / or high density polyethylene ("polyethylene" [0058]); wherein the closing element is formed from at least two polymers ("connector area 18 has, as closure area, at least one first material and at least one second material that have a different resistance with respect to the medium that is to be applied" [0057]), one of which being easier to break than the other, the polymer being easier to break forming the intended breaking point ("second material (lower resistance) forms the partial area 20 of the connector area 18 to be weakened and is distributed as a pattern in the first material (higher resistance)" [0057]); wherein the fluid line comprises only one lumen or an inner lumen and an outer lumen, wherein the closing element is arranged on an end face of the one lumen or the outer lumen and an end face of the inner lumen is arranged retracted into the outer lumen so that a gap is present between the end face of the inner lumen and the closing element ([0049]; FIGs. 2 & 3); wherein the connector, that is a connector of a concentrate container, and / or the pressure exertion element, that is a connector element of a blood treatment device or a dosing unit thereof, comprises at least one fluid line comprising an inner lumen and an outer lumen preferably arranged concentrically to each other ([0049]; FIGs. 2 & 3). Therefore, it would have been obvious modify the device of Naygauz to incorporate the teachings of Biehl to suitably “closes off the associated fluid-conveying system in a fluid-tight manner” ([0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781