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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/06/2026 has been entered.
Response to Amendment
The amendments filed on 02/06/2026 has been entered. Claims 1-2 have been amended. Accordingly, claims 1-2 are pending and under consideration.
Response to Arguments
Applicant’s arguments filed on 02/06/2026, with respect to the rejection(s) of claim(s) 1-2 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Yun et al. WO 2021230440 A1 (newly cited) in view of Jepson et al. US 5,957,898 A (newly cited).
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 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Yun et al. WO 2021230440 A1 (newly cited, hereinafter Yun) in view of Jepson et al. US 5,957,898 A (newly cited, hereinafter Jepson).
Regarding claim 1, Yun discloses a connector (Fig. 2 shows a spike port, and Par. 21 in the provided translation – “Figure 2 is an exploded perspective view of a spike port according to the present invention”) attachable to a bag containing liquid solutions for medical or nutritional use (Par. 1 in the provided translation – “a spike port for an IV bag”), said connector (Fig. 2) comprising:
a coupling part 10 (Fig. 2-3 – port body 10) for coupling to an end of a cylindrical tube T (Fig. 3 – connecting tube T) projecting from the bag (Par. 34 in the provided translation – “the above drainage tube (11) is inserted into the connecting tube (T) connected to the IV bag”; drainage tube 11 is a part of port body 10 as shown in Fig. 2), the coupling part 10 (Fig. 1-2) being a single integral body (Fig. 3 shows a cross-sectional view of the spike port, and port body 10 is a unitary body) and a first axial end 11a (Fig. 2-3 – portion 11a) of the coupling part 10 (Fig. 2) for forcibly inserting thereinto by axial pressure an end of the cylindrical tube T (Fig. 3) projecting from the bag (Par. 27 in the provided translation – “the above port body (10) has a drainage tube (11) that is inserted into a connecting tube (T) of a fluid bag (not shown in the drawing)”, and Par. 34 in the provided translation – “the above drainage tube (11) is inserted into the connecting tube (T) connected to the IV bag”),
the coupling part 10 (Fig. 2-3) having an axial hole (see annotated Fig. 3 below) with a first axial end E1 (see annotated Fig. 3 below) and a second axial end E2 (see annotated Fig. 3 below), which axial hole (see annotated Fig. 3 below) is closed by a pierceable inner membrane 12 (Fig. 3 – inner blocking membrane 12, and Par. 28 in the provided translation – “the inner barrier (12) functions to block the fluid from flowing out through the drainage tube (11) until the spike (S) is inserted…”) integral with the coupling part 10 (Fig. 3 – membrane 12 is shown to be unitary with the port body 10) at an intermediate location between the first E1 (see annotated Fig. 3 below) and second E2 axial ends (see annotated Fig. 3 below) of the axial hole (see annotated Fig. 3 below – membrane 12 is at an intermediate location between end E1 and end E2), and a closing part 20 (Fig. 2-3 – separation cap 20), which is placed to close the second axial end E2 (see annotated Fig. 3 below) of the axial hole (see annotated Fig. 3 below) of the coupling part 10 (Fig. 2-3) and is detachable from the coupling part 10 (Fig. 2-3, and Par. 30 in the provided translation – “the separation cap (20) so that they can be cut, is arranged along the circumferential direction of the port body (10) and the separation cap (20), and is made of a thin thickness that can be cut by an external force”),
the coupling part 10 (Fig. 2-3) and the closing part 20 (Fig. 2-3) forming a single integral body (Par. 29 in the provided translation – “The above separation cap (20) is integrally injection-molded on the upper part of the port body (10)”) provided with a frangible weakened section 30 (Fig. 3 – cutting grooves 30) for the detachment of the closing part 20 (Fig. 3) from the coupling part 10 (Fig. 3, and Par. 30 in the provided translation – “The above circumferential cutting groove (30) connects the port body (10) and the separation cap (20) so that they can be cut”).
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Annotated Fig. 3 of Yun
However, Yun does not currently disclose the coupling part comprising two coaxial cylindrical tubes of a same length which form therebetween an annular axial space with constant cross-section, which is axially accessible from outside at a first axial end of the coupling part.
Jepson, in the same field of endeavor of infusion therapy (Col. 1, line 15-16) and medical connectors (Col. 3, line 30-31), teaches the coupling part 424 (Fig. 13 – lower portion 434) comprising two coaxial cylindrical tubes (see annotated Fig. 13 below) which form therebetween an annular axial space with constant cross-section (see annotated Fig. 13 below), which is axially accessible from outside at a first axial end 426 (Fig. 13 – lower end 426) the coupling part 424 (Fig. 13).
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Annotated Fig. 13 of Jepson
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 coupling part of Yun to further have another coaxial cylindrical tube to form two coaxial cylindrical tube forming an annular axial space therebetween as taught by Jepson, in order to establish a connection to a medical device (Col. 20, line 36-39 of Jepson) and further secure the connection to the bag tube. Since Jepson discusses that said configuration can connect to a cylindrical catheter 15, as seen in Fig. 1 of Jepson, the combination of Yun in view of Jepson will also allow the modified connector to connect to the cylindrical connecting tube T (Fig. 3) of Jepson in the same manner. In other words, the connecting tube T will be inserted into the annular axial space, similarly to the catheter 15 in Fig. 1 of Jepson.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the length of the two coaxial cylindrical tubes of the combination to be of a same length, in order to fit the particular procedure being done since this claimed dimension of the tubes does not change the connector ability to attach to the connector of the medicinal bag. Since applicant has not given any criticality to why the dimension 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 a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 2, Yun in view of Jepson suggests the invention of claim 1. The combination further discloses wherein the single integral body 10+20 (Fig. 2-3 of Yun) comprises gripping fins 13, 22 (Fig. 2-3 of Yun – lower wings 13 and upper wings 22) which extend outwards from left and right sides of the coupling part 10 (Fig. 2-3 of Yun, and Par. 27 of Yun in the provided translation – “the above port body (10) has… a pair of lower wings (13) protrude from the upper side of the drainage tube (11)”) and the closing part 20 (Fig. 2-3 of Yun, and Par. 29 of Yun in the provided translation – “The above separation cap (20)… has a structure in which a pair of upper wings (22) protrude on both sides”), respectively, and are on the upper and lower axial sides of the weakened section 30 (Fig. 3 of Yun) of the single integral body 10+20 (see annotated Fig. 3 of Yun above – upper wings are arranged approximately at the second axial end E2, which is above the cutting groove 30; lower wings are arranged approximately at the first axial end E1, which is below the cutting groove 30).
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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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
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781