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 .
Claims 1-3, 6-13, and 18-21 are examined in this office action.
Claims 4-5 and 14-17 are cancelled.
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, 6-11, and 13 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Tsai et al. (US Pub No. 20170072182 A1).
Regarding claim 1, Tsai discloses a flexible plug (lid 10, flexible valve 20, containing seat 30, Fig. 1) for use with a solution container (syringe 2, Fig. 10), the flexible plug comprising:
a sealing member (flexible valve 20, Fig. 1) including a flexible section (flexible valve 20, Fig. 1) that extends to a beveled head (head portion 21, Fig. 2);
a rigid member holder (containing seat 30, Fig. 2) secured to the sealing member ("The opening end B2 of the flexible valve 20 is disposed on the bearing portion 3031 of the conduction structure 303 (of the containing seat 30)." - Para [0034], Fig. 9); and
a rigid sealing cap (lid 10, Fig. 1) including a wall (See annotated Fig. 2) defining a beveled opening (inserting hole 101, Fig. 2), the beveled head of the sealing member sealed within the beveled opening ("… part of the head portion 21 (of the flexible valve 20) is disposed in the inserting hole 101 of the lid 10, so the head portion 21 is sealed in the inserting hole 101." - Para [0034], Fig. 8) to prevent a flow of medical fluid through the flexible plug ("... The flexible valve is utilized the seal the injecting opening of the feeder." - Para [0005]).
PNG
media_image1.png
758
514
media_image1.png
Greyscale
Regarding claim 2, Tsai discloses the flexible plug (lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the rigid member (containing seat 30, Fig. 2) abuts against the rigid sealing cap (lid 10, Fig. 1) ("… the lid 10 engages with the containing seat 30, and the space S1 of the lid 10 is connected to the space S2 of the containing seat 30 …" - Para [0034], Fig. 8).
Regarding claim 3, Tsai discloses the flexible plug (lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the wall (See annotated Fig. 2 above) defining the beveled opening (inserting hole 101, Fig. 2) is an endwall of the rigid sealing cap (lid 10, Fig. 2).
Regarding claim 6, Tsai discloses the flexible plug (lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the beveled opening (inserting hole 101, Fig. 2) includes at least one half-round (See annotated Fig. 1) and the beveled head (head portion 21, Fig. 2) of the sealing member (flexible valve 20, Fig. 1) includes at least one mating half-round (See annotated Fig. 1).
PNG
media_image2.png
758
514
media_image2.png
Greyscale
Regarding claim 7, Tsai discloses the flexible plug (lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the beveled head (head portion 21, Fig. 2) is formed from the same material as the flexible section ("The flexible valve 20 has a head portion 21 ..." - Para [0027], Fig. 3) or is attached to the flexible section.
Regarding claim 8, Tsai discloses the flexible plug (lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the rigid member holder (containing seat 30, Fig. 2) includes an annular seat (conduction structure 303, Fig. 2) that accepts a mating flange (supporting portion 24, Fig. 2) of the sealing member (flexible valve 20, Fig. 2) ("The supporting portion 24 of the flexible valve 20 provides good strength so the flexible valve 20 is installed firmly in conduction structure 303 …" - Para [0031], Fig. 8).
Regarding claim 9, Tsai discloses the flexible plug (lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the flexible section (flexible valve 20, Fig. 1) extends from the mating flange (supporting portion 24, Fig. 2) of the sealing member (flexible valve 20, Fig. 2) through a bore (S2, Fig. 6) defined by the rigid member holder (containing seat 30, Fig. 2).
Examiner interprets bore to be the Merriam-Webster dictionary definition of "the long usually cylindrical hollow part of something (such as a tube or gun barrel)".
Regarding claim 10, Tsai discloses the flexible plug (lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the flexible section (flexible valve 20, Fig. 1) includes a flexible cylindrical section (flexible valve 20, Fig. 1).
Regarding claim 11, Tsai discloses a flexible plug assembly (lid 10, flexible valve 20, containing seat 30, Fig. 1) for use with a solution container (syringe 2, Fig. 10), the flexible plug comprising:
a sealing member (flexible valve 20, Fig. 1) including a flexible section (flexible valve 20, Fig. 1) that extends to a beveled head (head portion 21, Fig. 2);
a rigid member holder (containing seat 30, Fig. 2) secured to the sealing member ("The opening end B2 of the flexible valve 20 is disposed on the bearing portion 3031 of the conduction structure 303 (of the containing seat 30)." - Para [0034], Fig. 9);
a rigid sealing cap (lid 10, Fig. 1) including a wall (See annotated Fig. 2 above) defining a beveled opening (inserting hole 101, Fig. 2), the beveled head of the sealing member sealed within the beveled opening ("… part of the head portion 21 (of the flexible valve 20) is disposed in the inserting hole 101 of the lid 10, so the head portion 21 is sealed in the inserting hole 101." - Para [0034], Fig. 8) to prevent a flow of medical fluid through the flexible plug ("... The flexible valve is utilized the seal the injecting opening of the feeder." - Para [0005]); and
a port tube, sleeve port or Y-connector (guiding portion 32, Fig. 2), at least one of the sealing member, rigid member and rigid sealing cap sealed within the port tube, sleeve port or Y-connector (seat portion 31, Fig. 2).
Claim(s) 12 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US Pub No. 20170072182 A1) in view of Andreasen (US Patent No. 2157881).
Regarding claim 12, Tsai in view of Andreasen discloses the flexible plug assembly (Tsai, lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the beveled head (Tsai, head portion 21, Fig. 2) is unsealed from the beveled opening (Tsai, inserting hole 101, Fig. 2) to allow the flow of medical fluid through the flexible plug (Tsai, "… the head portion 21 no longer seals the space between the inserting hole 101 and the projection 103 … so the medicinal fluid of the syringe 2 goes through the flow path …" - Para [0035]).
Tsai does not expressly that the port tube, sleeve port or Y-connector is flexible so as to allow a user to grasp and twist or torque the rigid member holder and the rigid sealing cap through the port tube, sleeve port or Y-connector.
Andreasen teaches that the port tube, sleeve port or Y-connector is flexible (supply house 38, Fig. 4) so as to allow a user to grasp and twist or torque the rigid member holder and the rigid sealing cap ("… bending the hose sufficiently to rock the valve off its seat." - Page 2, Col. 1, Line 29-31) (valve 20, Fig. 4) through the port tube, sleeve port or Y-connector (supply house 38, Fig. 4).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the assembly of Tsai to include that the port tube, sleeve port or Y-connector is flexible so as to allow a user to grasp and twist or torque the rigid member holder and the rigid sealing cap through the port tube, sleeve port or Y-connector as taught by Andreasen for permitting water to travel through the ports (Andreasen, Page 2, Col. 2, Line 11).
Regarding claim 13, Tsai in view of Andreasen discloses the flexible plug assembly (Tsai, lid 10, flexible valve 20, containing seat 30, Fig. 1) as recited above, wherein
the rigid member (Tsai, containing seat 30, Fig. 2) abuts against the rigid sealing cap (Tsai, "… the lid 10 engages with the containing seat 30, and the space S1 of the lid 10 is connected to the space S2 of the containing seat 30 …" - Para [0034], Fig. 8).
Tsai does not expressly disclose that the rigid member and rigid sealing cap are sealed within the port tube, sleeve port, or Y-connector.
Andreasen teaches that the rigid member (valve 20, Fig. 4) and rigid sealing cap (valve 20, Fig. 4) are sealed within the port tube, sleeve port or Y-connector (supply house 38, Fig. 4).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the system of Tsai to include that the rigid member and rigid sealing cap are sealed within the port tube, sleeve port, or Y-connector as taught by Andreasen for permitting the water to travel through the ports (Andreasen, Page 2, Col. 2, Line 11).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 102(1) as being anticipated by Tsai et al. (US Pub No. 20170072182 A1) in view of Ramey et al. (WO 2012118762 A1).
Regarding claim 18, Tsai in view of Ramey discloses a method of manufacturing a medical fluid plug comprising:
a flexible sealing member (Tsai, flexible valve 20, Fig. 1) and a rigid member holder (Tsai, containing seat 30, Fig. 2);
inserting a rigid sealing cap (Tsai, lid 10, Fig. 1) over a flexible section of the flexible sealing member (Tsai, "… part of the head portion 21 (of the flexible valve 20) is disposed in the inserting hole 101 of the lid 10, so the head portion 21 is sealed in the inserting hole 101." - Para [0034], Fig. 8), the rigid sealing cap including a wall (Tsai, See annotated Fig. 2 above) defining a beveled opening (Tsai, inserting hole 101, Fig. 2); and
forming or attaching a beveled head to an end of the flexible section of the flexible sealing member (Tsai, head portion 21, Fig. 2) so that the beveled head seals the beveled opening in the wall of the rigid sealing cap (Tsai, "… part of the head portion 21 (of the flexible valve 20) is disposed in the inserting hole 101 of the lid 10, so the head portion 21 is sealed in the inserting hole 101." - Para [0034], Fig. 8).
Tsai does not expressly disclose overmolding or 2K molding a flexible sealing member.
Ramey teaches overmolding or 2K molding a flexible sealing member ("… the connector 18 is manufactured by an overmolding process …" - Para [0063]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Tsai to include overmolding or 2K molding a flexible sealing member as taught by Ramey for using manufacturing processes sufficient to provide the desired shape of the components (Ramey, Para [0063]).
Regarding claim 19, Tsai in view of Ramey discloses the method as recited above, which includes
the beveled head (Tsai, head portion 21, Fig. 2) at the end of the flexible section (Tsai, flexible valve 20, Fig. 1) of the flexible sealing member (Tsai, flexible valve 20, Fig. 1) so that the beveled head seals the beveled opening in the wall of the rigid sealing cap (Tsai, "… part of the head portion 21 (of the flexible valve 20) is disposed in the inserting hole 101 of the lid 10, so the head portion 21 is sealed in the inserting hole 101." - Para [0034], Fig. 8).
Tsai does not expressly disclose thermoforming the beveled head.
Ramey teaches thermoforming the beveled head ("The infusion set 16 and components thereof can be formed using … thermoforming …" - Para [0063]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Tsai to include thermoforming the beveled head as taught by Ramey for using manufacturing processes sufficient to provide the desired shape of the components (Ramey, Para [0063]).
Regarding claim 20, Tsai in view of Ramey discloses the method as recited above, which includes
adhering the beveled head (Tsai, head portion 21, Fig. 2) to the end of the flexible section (Tsai, flexible valve 20, Fig. 1) of the flexible sealing member (Tsai, flexible valve 20, Fig. 1) so that the beveled head (Tsai, head portion 21, Fig. 2) seals the beveled opening in the wall of the rigid sealing cap (Tsai, "… part of the head portion 21 (of the flexible valve 20) is disposed in the inserting hole 101 of the lid 10, so the head portion 21 is sealed in the inserting hole 101." - Para [0034], Fig. 8).
Examiner interprets the head portion to be a part of the flexible valve and thus for the two parts to be adhered.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tsai et al. (US Pub No. 20170072182 A1) in view of Ramey et al. (WO 2012118762 A1) and Andreasen (US Patent No. 2157881).
Regarding claim 21, Tsai in view of Ramey and Andreasen discloses the method as recited above, which includes
sealing at least the rigid sealing cap (Tsai, lid 10, Fig. 1) to form a medical fluid plug assembly (Tsai, lid 10, flexible valve 20, containing seat 30, Fig. 1).
Tsai in view of Ramey does not expressly disclose sealing at least the rigid sealing cap within a port tube, sleeve port or Y-connector.
Andreasen teaches sealing at least the rigid sealing cap (valve 20, Fig. 4) within a port tube, sleeve port or Y-connector (supply house 38, Fig. 1).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Tsai in view of Ramey to include sealing at least the rigid sealing cap within a port tube, sleeve port or Y-connector as taught by Andreasen for permitting the water to travel through the ports (Andreasen, Page 2, Col. 2, Line 11).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ESHA P KASHYAP whose telephone number is (571)272-9890. The examiner can normally be reached Monday - Friday 8:30am - 5:00pm.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights