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 06/23/2026 have been entered. Claim 1 has been amended. Accordingly, claims 1-2 are pending and under consideration.
Response to Arguments
Applicant's arguments filed on 06/23/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “another difference between Yun and the presently claimed invention is that according to Yun, the first axial end 11a is wound by a thin leakage blocking film 41 which avoids leakage of liquid from the bag when the spike is pulled out of the drainage tube… This means that it would not have been obvious for a person having ordinary skill in the art to replace the drainage tube 11 with first axial end 11a and leakage blocking film 41 of Yun with the lower end 426 of the connector of Figs. 13 of Jepson, because the provision of the blocking film 41 would have made it impossible for the lower end 426 to receive the connecting tube. Or, it would have been necessary to renounce the liquid blocking function of the film 41, which is a fundamental feature disclosed by Yun. Use of the annular axial space of Jepson in lieu of the monotube end of the drainage tube of Yun jointly with the leakage blocking film of Yun would clearly be impossible” on page 6-7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. While Examiner acknowledges the presence and function of Yun’s leakage blocking film 41 as discussed by Applicant, it is noted that the established rejection from the Office Action mailed 03/23/2026 and this Office Action (see rejection of claims below) discuss the modification such that the coupling part of Yun further includes another coaxial cylindrical tube to form an annular axial space as taught by Jepson, rather than complete replacement of Yun’s drainage tube 11 with the tube 424 of Jepson as traversed. The modification would still implement the use of the leakage blocking film 41 of Yun on the original coaxial cylindrical tube 11 in a modified two-coaxial-tube coupling system (see Fig. 30 of Bullington et al. US 2018/0140240 A1 for an evidentiary product – sheath 1341 in a two-coaxial tube coupling system).
Regarding Applicant’s remarks stating that “In an attempt to rectify Yun's deficiencies, the Office relies upon the disclosure of Jepson. However, there is simply no teaching, suggestion, or motivation in either of Yun and Jepson, or any other reasons relied upon by the Examiner, that would have led one to select the references and combine them, let alone in a way that would result in the claimed invention, including the advantages attendant thereto” on page 7 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Jepson teaches a configuration for establishing to a medical device (Col. 20, line 36-39), and this configuration appears to be generally well-known in the art (see examples of a coupling part/medical connector in Fig. 2C of Paradis US 5,289,849 A, Fig. 7 of Guest US 5,000,745 A¸ Fig. 3 of Raines US 4,535,820 A¸ Fig. 3 of Peterson et al. US 5,098,405 A).
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 (previously cited, hereinafter Yun) in view of Jepson et al. US 5,957,898 A (previously 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 into 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 for forcibly inserting into the annular axial space.
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) for forcibly inserting into the annular axial space (see annotated Fig. 13 below, and Col. 20, line 36-40 – “The housing also includes a lower portion 424 having a lower end 426 configured to establish a connection to a medical device (not shown) such as a catheter 15 (FIG. 1)”, and Fig. 1 for exemplary demonstration of the connection).
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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 Yun 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Choi KR 20210108197 A teaches a medical bag with blood leak prevention
THIS ACTION IS MADE FINAL. 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
/ANDREW J MENSH/Primary Examiner, Art Unit 3781
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