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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “crosspiece” in claim 18 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “III” in Fig.2. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 11-13, 15 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braun Melsungen AG (DE 29505787 U1, herein, Braun).
Regarding claim 11, Braun discloses a connector closure cap (closure piece 10 – Fig.1) of a medical fluid-conducting set, the connector closure cap (closure piece 10 – Fig.1) comprising:
a base plate (see annotated Fig.1) surrounding a through-opening (plug-in socket 12 – Fig.1), the through-opening having a flat side comprising a sealing sleeve ("sealing profile is provided on the inner surface of the plug-in socket", see para [0021] and outer surface of 13 – Fig.2) that projects from the flat side, wherein an internal cross-section of the sealing sleeve overlaps with the through-opening in the base plate at least in sections,
the through-opening in the base plate being sealed with a membrane element (filter membrane 25 – Fig.2) that is gas- permeable but liquid-impermeable (“filter element is an air-permeable membrane... that allows air to escape and indicates the success of the puncture through red coloration, but does not allow blood to escape”, see para [0003]),
the base plate having a radial step (annular shoulder 18 – Fig.2) that is radially-inwardly directed on/in the through- opening on a circumferential side, the radial step forming a supporting ring surface (surface of inner ring groove 22 – Fig.2) for the membrane element,
the radial step comprising a circumferential axial groove (inner ring groove 22 – Fig.2) adjacent to an inner circumferential wall (inner surface 13 – Fig.2) of the through-opening, and
the membrane element having an axial ring projection (see annotated Fig.1) having a shape that corresponds to a geometry of the circumferential axial groove, the axial ring projection configured to engage in the circumferential axial groove when the membrane element is placed on the supporting ring surface (“teeth 21 are bent inwards... at the ring groove 22, so that they form a cover parallel to the filter membrane 25”, see para [0034]).
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Regarding claim 12, Braun discloses the connector closure cap (closure piece 10 – Fig.1) according to claim 11, wherein a circumferential sealing lip (" a sealing profile in the form of a circumferential sealing lip 14”, see para [0032], Fig.1) is formed on an outer circumferential surface of the sealing sleeve.
Regarding claim 13, Braun discloses the connector closure cap (closure piece 10 – Fig.1) according to claim 11, wherein a circumferential convex radius is formed between the base plate and the sealing sleeve (outer surface of 13 – Fig.2), wherein the circumferential convex radius forms an axial stop when the sealing sleeve is inserted into a fluid passage of a connector (connector 30 – Fig.1) (“when the closure piece 10 is attached to the connector 30 {Figure 1) the socket 12 surrounds a main part of the length of the outer cone 31 and the sealing lip 14 seals the outer cone 31 so that no liquid can enter the threaded area of the connector 30”, see para [0035]).
Regarding claim 15, Braun discloses A medical fluid-conducting set for administering a medical fluid (“use of the closure piece with an infusion set”, see para [0019]) stored in a container, the medical fluid-conducting set comprising:
the connector closure cap (closure piece 10 – Fig.1) according to claim 11 (recited above, see claim 11); and
a line connectable (channel 29 – Fig.2) to the container for fluidically connecting the container to a connector (“connector 30 is traversed by a straight channel 29, which in this example symbolizes the opening of the infusion line”, see para [0035]),
wherein the connector closure cap closes an internal fluid passage of the connector when the connector is in fluid communication with the line, forming a fluid-tight and air-permeable barrier (“connector 30 is traversed by a straight channel 29, which in this example symbolizes the opening of the infusion line, which is to be closed by the closure piece 10... when the closure piece 10 is attached to the connector 30 {Figure 1) the socket 12 surrounds a main part of the length of the outer cone 31... so that no liquid can enter.... the sealing piece 10 with welded-in air-permeable and hydrophobic filter membrane 25 forms a protective cap with filling stop”, see paras [0035] - [0037]).
Regarding claim 18, Braun discloses the medical fluid-conducting set according to claim 17, further comprising at least one crosspiece (internal threaded sleeve 32 – Fig.1) formed on an inner circumferential surface of the sheathing (jacket 24 – Fig.1).
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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.
Claims 14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Braun, in view of Karthikeyan et al. (US 20190247642 A1, herein, Karthikeyan).
Regarding claim 14, Braun discloses the connector closure cap (closure piece 10 – Fig.1) according to claim 11, wherein the membrane element is made of an acrylic copolymer or a sintered polymer.
Braun does not appear to expressly disclose wherein the membrane element is made of an acrylic copolymer or a sintered polymer.
Karthikeyan teaches wherein the membrane element is made of an acrylic copolymer or a sintered polymer (“the filter element 40 may include an acrylic copolymer membrane cast”, see para [0056]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Braun so that the membrane element is made of an acrylic copolymer as taught by Karthikeyan to further “prevent accidental uncoupling of the flow control plug from the luer adapter prior to use” (Karthikeyan para [0007]).
Regarding claim 16, Braun discloses the medical fluid-conducting set according to claim 15, as recited above.
Braun does not appear to expressly disclose a connector having a hose receiving portion for receiving the line and a connector receiving portion with an inner cone and a securing element for fluid-tight connection to a patient- side connector.
Karthikeyan teaches a connector having a hose receiving portion for receiving the line (Luer access port 24 – Fig.4A) and a connector receiving portion with an inner cone (distal end 38 of flow control plug 34, “distal end 38 may include a luer-lock portion may include the cylinder 42 and a taper-shaped luer tip 44 spaced apart”, see para [0052], Fig.4A) and a securing element for fluid-tight connection to a patient- side connector.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the disclosure of Braun so that the connector includes having a hose receiving portion and a connector receiving portion as taught by Karthikeyan to further “prevent accidental uncoupling of the flow control plug from the luer adapter prior to use” (Karthikeyan para [0007]).
Regarding claim 17, Braun discloses the medical fluid-conducting set according to claim 16, wherein the connector closure cap (closure piece 10 – Fig.1) has a sheathing (jacket 24 – Fig.1) arranged on the base plate coaxially to the sealing sleeve (outer surface of 13 – Fig.2), the sheathing enclosing the sealing sleeve in a radial direction so that a hollow space (see annotated Fig.1) is formed between the sealing sleeve and the sheathing, the connector receiving portion projecting into the hollow space in order to be pressed against the sealing sleeve by the sheathing (“closure piece 10 is attached to the connector 30 {Figure 1) the socket 12 surrounds... the outer cone 31 and the sealing lip 14 seals the outer cone 31... the sealing is provided by the jacket part 24”, see para [0035]- [0036]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAGWA M ABU-DAYEH whose telephone number is (571)270-0389. The examiner can normally be reached 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at (571)270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.M.A./Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783
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