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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn claims 34-37 do not have support in the original filing of application EP19191551.1. Therefore, withdrawn claims 34-37 will have an effective priority date of 08/11/2020 according to the support provided in PCT/EP2020/072498. Claims 20-33 and withdrawn claim 38 will have an effective priority date of 08/13/2019.
Response to Amendment
The amendments filed on 02/09/2026 has been entered. Claim 20 has been amended. Accordingly, claims 20-27 and 31-33 are pending and under consideration.
Response to Arguments
Applicant’s arguments filed 02/09/2026, with respect to the rejection(s) of claim(s) 20 under 35 U.S.C 103 regarding the teachings of Kitani (page 11-13 of Applicant’s remarks) 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 Therefore, the rejection has been withdrawn.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 Kitani et al. US 2008/0004600 A1 (previously cited) in view of Carrez et al. EP 2712652 A2 (previously cited), as necessitated by amendment.
Applicant's arguments filed on 02/09/2026 regarding the teachings of Carrez have been fully considered but they are not persuasive.
Regarding Applicant’s remarks stating that “unlike currently amended claim 20, which recites a plurality of socket teeth (14) on the female connector, the cited portions only disclose a single structure (25b)” on page 13-14 of Applicant’s remarks, Examiner acknowledged the remarks, but respectfully disagrees. While the Figures of Carrez may not completely show a plurality of teeth 25, Par. 40 of Carrez in the provided translation discusses the current embodiment includes two teeth 25 extending from the corresponding fitting 20:
“Here, the locking means each include two teeth 15, 25, extending from the corresponding
fitting 10, 20, and at least as many notches 33, for example four for each fitting 10, 20.”
Thus, Carrez reads on the claimed limitation.
Regarding Applicant’s remarks stating that “…this structure of Carrez's mechanism fundamentally differs from what is claimed in currently amended claim 20. Carrez is primarily concerned with preventing accidental unscrewing but does not aim to make the connection non-removable. Rather, the connectors in Carrez are designed to be disengaged when necessary. Indeed, this fundamental difference can be seen by comparing the connection structures between Carrez and the present disclosure” on page 14 of Applicant’s remarks, Examiner acknowledged, but respectfully disagrees. A number of paragraphs in of Carrez discuss a non-removable connection system after all the parts have been engaged. For example, Par. 9 of Carrez in the provided translation discusses that “the invention also aims to prevent any unscrewing of the medical device(s), and to serve as an adapter where appropriate in order to transform a screw connection of a given type into a connection of a different type, without risk of subsequent disassembly”; or Par. 38 of Carrez in the provided translation discusses that “neither of the fittings 10, 20 is accessible without dismantling the connection system 1, and therefore cannot be grasped by the operator since they are both housed for the most part in the casing 30”. Par. 48 of Carrez in the provided translation also states that “when the housing 30 is fitted onto the male fitting 10 and the female fitting 20, and the male fitting 10 and the female fitting 20 are coupled, it is no longer possible to extract them from the housing 30.” Therefore, the system of Carrez when combined with Kitani will produce a connection device that is irremovable/non-removable. While Applicant may traverse on grounds that a “non-removable” or “irremovable” connection is explicitly mentioned by Carrez, Examiner contends that the disclosure of Carrez has suggested such a feature based on the evidence of aforementioned paragraphs. Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
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.
Claims 20-27, and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Kitani et al. US 2008/0004600 A1 (previously cited, hereinafter Kitani) in view of Carrez et al. EP 2712652 A2 (previously cited, hereinafter Carrez).
Regarding claim 20, Kitani discloses a non-removable connection system 20 (Fig. 1 – luer-locking fitting connection mechanism 20) for a medical apparatus (Par. 2 – “the supply of medicinal solutions or blood to a patient, for example, has been conducted using an infusion line or blood transfusion line furnished with a tube. In this case, a luer-locking fitting connection mechanism is used”), said non-removable connection system 20 (Fig. 1) comprising:
a first male connector 22 (Fig. 4 – male connector 22) comprising a first fluid coupling portion 32 (Fig. 4 – luer member 32);
a second female connector 21 (Fig. 4 – female connector 21) having a tubular shape (Par. 23 – “the female connector 21 is structured with a tubular main connector unit 23”) defining an internal channel (Fig. 4 – the hollow center of main connector unit 23) for fluid transport (Par. 2 – the intended use of the invention is for medicinal solution or blood flow) and comprising an external lateral wall (Fig. 4 – the outer surface of main connector unit 23), wherein the second female connector 21 (Fig. 4) comprises a second fluid coupling portion 23 (Fig. 4 – main connector unit 23) connectable, in a fluid tight manner (Par. 33 – “female connector 21 and male connector 22 are linked to form a passage in a suitably connected condition that will not give rise to liquid leakage”), to the first fluid coupling portion 32 (Fig. 9 and Par. 14 – “FIG. 9 is a cross section showing the condition wherein the female connector and male connector are connected”) of the first male connector 22 (Fig. 9), so that a fluid is able to internally flow between the first male connector 22 (Fig. 9) and the second female connector 21 (Fig. 9, and Par. 21 discusses the flow of medicinal solutions within the line set 10, thus said solution flows through the connection mechanism 10 of the male and female connector 22, 21), the second female connector 21 (Fig. 4) further comprising a second hooking portion 25 (Fig. 4 – male threads 25) arranged at the respective coupling portion 23 (Fig. 4, and Par. 23 – “Male threads 25 are provided on the outer circumference of main connector unit 23 from the tip toward the central area”) and at least one second locking projection 26 (Fig. 4 – annular engagement projection 26), the at least one locking projection 26 (Fig. 4) of the second female connector 21 (Fig. 4) emerging from, and being radially arranged on, the external lateral wall 23 (Fig. 2 shows the annular engagement projection 26 protrudes outward and circumferentially from the exterior surface of female connector 21) of the second female connector 21 (Fig. 2), said hooking portion 25 (Fig. 4) of the second female connector 21 (Fig. 4) being side by side with said at least one locking projection 26 (Fig. 4, and Par. 23 – the threads 25 and projection 26 are next to each other on the female connector 21) of the second female connector 21 (Fig. 4);
a collar 28 (Fig. 4 – luer-locking fitting member 28) comprising a main body 28 (Fig. 4) having a tubular shape (Par. 28 – “The luer-locking fitting member 28 is formed in an approximately cylindrical shape”) extending in depth between an internal lateral wall IW and an external lateral wall EW (see annotated Fig. 4 below), the collar 28 (Fig. 4) being mounted over the first male connector 22 (Fig. 4) so that the main body 28 (Fig. 4) externally surrounds at least part of the first male connector 22 (Fig. 4 – collar 28 partially surrounds a left end of the male connector 22), the collar 28 (Fig. 4) comprising a first hooking portion 34 (Fig. 4 – female threads 34) arranged on said internal lateral wall IW (see annotated Fig. 4 below, and Par. 29 – “female threads 34 that can screw to the male threads 25 of female connector 21 are formed on the internal circumferential surface of luer-locking fitting member 28”) and being engageable to the second hooking portion 25 (Fig. 4, and Par. 29) of the second female connector 21 (Fig. 4) through an engagement rotation along an engagement direction (Par. 29 – “female threads 34 that can screw to the male threads 25 of female connector 21 are formed on the internal circumferential surface of luer-locking fitting member 28”, and Par. 32 – “Then the luer member 32 of male connector 22 is placed inside female connector 21, the male threads 25 and female threads 34 are brought into contact, and the luer-locking fitting member 28 is rotated in a predetermined circumferential direction, thus causing the male threads 25 and female threads 34 to be screwed together, as shown in FIG. 8”), wherein in an engaged configuration (Fig. 9 shows an engaged configuration) the first hooking portion 34 (Fig. 9) of the collar 28 (Fig. 9) and the second hooking portion 25 (Fig. 9) of the second female connector 21 (Fig. 9) prevent axial removal of the collar 28 (Fig. 9) from the second female connector 21 (Fig. 9, and Par. 33 – “Also, in this case, the engagement projection 26 of female connector 21 is prevented from retreating backward with respect to male connector 22…”);
wherein the collar 28 (Fig. 4) further comprises at least one first locking projection 35 (Fig. 4 - passive engagement member 35) arranged on the internal lateral wall IW (see annotated Fig. 4 below, and Par. 29 – “a passive engagement member 35… is formed… on internal circumferential surface of luer-locking fitting member 28”) of the collar 28 (Fig. 4), side by side with said hooking portion 34 (Fig. 4 – the female threads 34 are side by side with the annular engagement member 35), and being engageable to the at least one second locking projection 26 (Fig. 4) of the second female connector 21 (Fig. 4, Fig. 9, and Par. 29 – “a passive engagement member 35 that can engage with engagement projection 26 of female connector 21 is formed at the tip portion of female threads 34 on internal circumferential surface of luer-locking fitting member 28”) through the engagement rotation of the collar 28 (Fig. 9) with respect to the second female connector 21 (Fig. 9, and along the engagement direction (Par. 33 – “The luer-locking fitting member 28 is then rotated further such that a suitable screwed together condition… is achieved. In this way, as shown in FIG. 9, engagement projection 26 of female connector 21 and passive engagement member 35 of male connector 22 become engaged”), wherein in a coupled configuration (Fig. 9 shows the engaged configuration) the at least one first locking projection 35 (Fig. 9) and the at least one second locking projection 26 (Fig. 9) prevent a disengagement rotation of the collar with respect to the second female connector (Par. 35 – “the engagement projection 26 provided on the external circumferential surface of female connector 21 is engaged with the passive engagement member 35 provided to the internal circumferential surface of luer-locking fitting member 28. Accordingly, the male threads 25 and female threads 34 will be strongly tightened to eliminate problems such as… and loosening between male threads 25 and female threads 34”), said disengagement rotation being a rotation in a opposite direction with respect to said engagement rotation (Par. 35 discusses prevention of loosening between threads 25 and female threads 34, which is a prevention of the connectors unscrewing in a reversed direction);
wherein by the engagement rotation (Fig. 4, 8-9 show the process of engagement rotation), the non-removable connection system 20 (Fig. 1) is configurable at least from an unlocked condition (Fig. 4) to a locked condition (Fig. 8-9);
wherein the first male connector 22 (Fig. 4) and the second female connector 21 (Fig. 4) are separated from each other (Fig. 4 – prior to connection) and the collar 28 (Fig. 4) is axially constrained to the first male connector 22 (Fig. 4, and Par. 25 – “male connector 22 is structured with… a luer-locking fitting member 28 that is attached to the outer circumference of joint part 27”) and wherein in the unlocked condition (Fig. 4): (i) the collar 28 (Fig. 4) is movable by rotation with respect to the first male connector 22 (Fig. 4 – “…a luer-locking fitting member 28 that is attached to the outer circumference of joint part 27 and can rotate circumferentially about the axis of joint part 27”) and (ii) the at least one first locking projection 35 (Fig. 4) and the at least one second locking projection 26 (Fig. 4) are in an uncoupled configuration (Fig. 4 – projection 35 and 26 are not engaged yet), in the unlocked condition (Fig. 4) the locking projection 35 (Fig. 4) of the collar 28 (Fig. 4) being not engaged with, and separated from, the locking projection 26 (Fig. 4) of the second female connector 21 (Fig. 4); and
wherein in the locked condition (Fig. 9 – already engaged and connected): (i) the at least one first locking projection 35 (Fig. 9) and the at least one second locking projection 26 (Fig. 9) are in the coupled configuration (Fig. 9 – projection 35 and 26 are engaged), (ii) the first hooking portion 34 (Fig. 9) and the second hooking portion 25 (Fig. 9) are in the engaged configuration (Fig. 9 – female threads 34 screw to the male threads 25), and (iii) the collar 28 (Fig. 9) is engaged to the second female connector 21 (Fig. 9) through said engagement rotation (Par. 33 – “The luer-locking fitting member 28 is then rotated further such that a suitable screwed together condition of male threads 25 and female threads 34 is achieved”) and the at least one second locking projection 26 (Fig. 9) and the second hooking portion 25 (Fig. 9) respectively cooperating with the at least one first locking projection 35 (Fig. 9) and the first hooking portion 34 (Fig. 9) thereby preventing disengagement of the first male connector 22 (Fig. 9) from the second female connector 21 (Fig. 9, and Par. 33 – “Also, in this case, the engagement projection 26 of female connector 21 is prevented from retreating backward with respect to male connector 22 by projecting member 35a of passive engagement member 35. Therefore, a suitable screwed together condition of male threads 25 and female threads 34 is maintained without this screwed together state of male threads 25 and female threads 34 becoming looser”),
However, Kitani does not disclose wherein the collar is irremovably engaged to the second female connector, wherein the at least one locking projection of the second female connector comprises a plurality of socket teeth and the at least one locking projection of the collar comprises a plurality of socket teeth so that when the plurality of socket teeth of the collar face the plurality of socket teeth of the second female connector, the plurality of socket teeth of the second female connector irremovably engage the plurality of socket teeth of the collar and the engagement rotation is allowed and the disengagement rotation is prevented,
wherein the plurality of socket teeth of the locking projection of the second female connector are arranged on the external lateral wall of the second female connector and the plurality of socket teeth of the locking projection of the collar are arranged on the internal wall of the collar whereby the plurality of socket teeth of the locking projection of the second female connector, the plurality of socket teeth of the locking projection of the collar are directly interposed between the second female connector and the collar, and each of the plurality of socket teeth include a slide surface and a lock surface, wherein the lock surface engages a collar projection to prevent disengagement rotation.
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Annotated Fig. 4 of Kitani
Carrez, in the same field of endeavor of medical connection system (Par. 1 in the provided translation), teaches wherein the collar 30 (Fig. 4a-4b – housing 30) is irremovably engaged to the second female connector 20 (Fig. 3a, Fig. 5c, and Par. 36, 38 in the provided translation), wherein the at least one locking projection 25a (Par. 43 in the provided translation – overthickness 25a) of the second female connector 20 (Fig. 5c-5d, and Fig. 3a – female fitting 20) comprises a plurality of socket teeth 25 (Fig. 3a, Fig. 5c-5d – teeth 25 of female fitting 20) and the at least one locking projection 33 (Fig. 4a-4c – notch 33) of the collar 30 (Fig. 4a-4c and Fig. 5c-5d – housing 30) comprises a plurality of socket teeth 33 (Fig. 4b, Fig. 5c-5d – notches 33 of housing 30) so that when the plurality of socket teeth 33 (Fig. 4a-4c) of the collar 30 (Fig. 4a-4c) face the plurality of socket teeth 25 (Fig. 3a, Fig. 5c-5d) of the second female connector 20 (Fig. 5c-5d), the plurality of socket teeth 25 (Fig. 3a, Fig. 5c-5d) of the second female connector 20 (Fig. 5c-5d) irremovably engage the plurality of socket teeth 33 (Fig. 4b, Fig. 5c-5d) of the collar 30 (Fig. 4a-4c, Par. 52 in the provided translation – “…prevents an operator from holding it fixed in rotation in order to unscrew the device connected to it”, and Par. 53 in the provided translation – “the housing 30 can for example be fitted onto one of the fittings 10, 20, say the female fitting 20, by positioning the teeth 25 of the female fitting 20 opposite the corresponding notches 33 of the housing 30”) and the engagement rotation is allowed and the disengagement rotation is prevented (Par. 39 in the provided translation – “the means for locking the housing 30 against rotation each include at least one notch 33, adapted to cooperate with a tooth 15, 25 made in the corresponding fitting 10, 20”, and Par. 52 in the provided translation – “the male fitting 10 and the female fitting 20, coupled so as to be mobile in rotation relative to each other, and substantially fixed in translation, housed in the casing 30”)
wherein the plurality of socket teeth 25 (Fig. 3a) of the locking projection 25a (Fig. 3a) of the second female connector 20 (Fig. 3a) are arranged on the external lateral wall of the second female connector 20 (Fig. 3a – teeth 25 are disposed on the exterior of the female fitting 20) and the plurality of socket teeth 33 (Fig. 4b) of the locking projection 33 (Fig. 4b) of the collar 30 (Fig. 4b) are arranged on the internal wall of the collar 30 (Fig. 4b-4c – notches 33 are disposed on the interior of housing 30) whereby the plurality of socket teeth 25 of the locking projection 25a (Fig. 5c-5d) of the second female connector 20 (Fig. 5c-5d), the plurality of socket teeth 33 (Fig. 5c-5d) of the locking projection 33 (Fig. 5c-5d) of the collar 30 (Fig. 5c-5d) are directly interposed between the second female connector 20 (Fig. 5c-5d) and the collar 30 (Fig. 5c-5d, and Par. 53 in the provided translation), and each of the plurality of socket teeth 25 (Fig. 3a-3b) include a slide surface 25c (Fig. 3a – guide edge 25c) and a lock surface 25b (Fig. 3a – locking edge 25b), wherein the lock surface 25b (Fig. 3a) engages a collar projection 33b (Fig. 4a-4b – locking edge 33b) to prevent disengagement rotation (Par. 39 in the provided translation – “the means for locking the housing 30 against rotation each include at least one notch 33, adapted to cooperate with a tooth 15, 25 made in the corresponding fitting 10, 20”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the locking projections of Kitani, which are currently the protrusions 26 and 35a, that allows the collar and the female connector to engage, for the plurality of socket teeth of Carrez, since these mechanisms perform the same function of enforcing engagement between two components. Simply substituting one engagement mechanism for another would yield the predicable result of allowing two connecting members to couple to each other. See MPEP 2143. Furthermore, 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 locking projections of Kitani to have the locking projections as taught by Carrez, in order to provide a medical connection system that is not possible to extract/unscrew any of female/male fitting when in a coupled configuration (Par. 48 of Carrez in the provided translation).
Regarding claim 21, Kintani in view of Carrez discloses the invention of claim 20. Kintani in view of Carrez further discloses wherein:
the first coupling portion 32 (Fig. 4 of Kitani) of the first male connector 22 (Fig. 4 of Kitani) extends in length along a first fluid flow axis (see annotated Fig. 4 of Kitani above);
the second coupling portion 23 (Fig. 4 of Kitani) of the second female connector 21 (Fig. 4 of Kitani) extends in length along a second fluid flow axis (see annotated Fig. 4 of Kitani above);
wherein the first fluid flow axis is aligned, at least when the first coupling portion 32 (Fig. 4 of Kitani) is connected to the second coupling portion 23 (Fig. 4 of Kitani), to the second fluid flow axis (see annotated Fig. 4 of Kitani above, and Fig. 9 of Kitani – first and second fluid flow axis is coaxial when connector 21 and 22 are connected); and
wherein the engaged configuration (Fig. 9 of Kitani) determines an axial constraint between the first male 22 and second female connectors 21 (Fig. 9 of Kitani, and Par. 33 of Kitani – “Also, in this case, the engagement projection 26 of female connector 21 is prevented from retreating backward with respect to male connector 22…”), said axial constraint being along the first fluid flow axis or the second fluid flow axis (see annotated Fig. 4 of Kitani above, and Par. 33 of Kitani – no retreating backward of female connector 21 with respect to male connector 22 indicates no axial movement along the first/second flow axis).
Regarding claim 22, Kitani in view of Carrez discloses the invention of claim 20. Kitani in view of Carrez further discloses wherein the first male connector 22 (Fig. 4 of Kitani) comprises a main abutment portion MA (see annotated Fig. 8 of Kitani below) and the collar 28 (Fig. 4 of Kitani) comprises collar abutment portion CA (see annotated Fig. 8 of Kitani below) configured to contact the main abutment portion MA (see annotated Fig. 8 of Kitani below) of the first male connector 22 (Fig. 4 of Kitani) when disposed in an abutment configuration (Fig. 9 of Kitani shows an abutment configuration where the annotated main abutment portion MA is in contact with the collar abutment portion), wherein in said abutment configuration (Fig. 9 of Kitani) the collar 28 (Fig. 9 of Kitani) is axially constrained with respect to the first male connector 22 (Fig. 9 of Kitani) at least along one axial direction (Fig. 9 of Kitani – the collar 28 abuts the main abutment portion MA of the male connector 22 in the axial direction), so that, at least when the non-removable connection system 20 (Fig. 1 of Kitani) is disposed in the engaged configuration (Fig. 9 of Kitani), the collar 28 (Fig. 9 of Kitani) axially engages the first male connector 22 to the second female connector 21 (Fig. 9 of Kitani – collar 28 provides engagement with the female connector 21 via threads and engagement with the male connector 22 via the annotated abutment portions), and
wherein the coupled configuration (Fig. 9 of Kitani) is defined at least at an end stage of the engagement rotation between the collar 28 and the second female connector 21 (Fig. 9 of Kitani – the collar 28 fully engages with the collar 28 via threads).
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Annotated Fig. 8 of Kitani
Regarding claim 23, Kitani in view of Carrez discloses the invention of claim 22. Kitani in view of Carrez further discloses wherein the first male connector 22 (Fig. 4 of Kitani) comprises an auxiliary abutment portion “AA” (see annotated Fig. 8 of Kitani above – auxiliary abutment portion “AA”), said auxiliary abutment portion “AA” (see annotated Fig. 8 of Kitani above) being configured to block an axial sliding of the collar 28 along a direction opposite to said axial direction (Fig. 9 of Kitani and annotated Fig. 8 of Kitani above – the auxiliary abutment portion “AA” is capable of preventing axial sliding of collar 28 toward tube 17), and wherein the collar 28 (Fig. 4 of Kitani) is:
axially constrained to the first male connector 22 (Fig. 9 of Kitani) through said main “MA” and auxiliary abutment portions “AA” of the first male connector 22 (see annotated Fig. 8 of Kitani above and Fig. 9 of Kitani – collar 28 is constraint between the main abutment portion Ma and auxiliary abutment portion AA), so that an axial movement of the collar 28 (Fig. 8-9 of Kitani) with respect to the first male connector 22 (Fig. 8-9 of Kitani) is substantially prevented (see annotated Fig. 8 of Kitani above and Fig. 9 of Kitani – collar 28 is constraint between the main abutment portion MA and auxiliary abutment portion AA)
Regarding claim 24, Kitani in view of Carrez discloses the invention of claim 22. Kitani in view of Carrez further discloses wherein the first male connector 22 (Fig. 4 of Kitani) comprises a main body 27 (Fig. 4 of Kitani – joint part 27) having a tubular shape (Par. 25 of Kitani – “male connector 22 is structured with an approximately tubular joint part 27”) defining an internal channel (Fig. 4 of Kitani – the hollow space in center of the joint part 27) for passage of the fluid (Par. 2 of Kitani – the intended use of the invention is for medicinal solution or blood flow), said main “MA” and auxiliary abutment portions “AA” radially extending away from said main body 27 (see annotated Fig. 8 of Kitani above – portion MA and AA protrude outward from the joint part 27), the first male connector 21 (Fig. 4 of Kitani) further comprising a recess 31a (Fig. 4-5 of Kitani – concavity 31a) interposed between the main “MA” and the auxiliary abutment portions “AA” (see annotated Fig. 8 of Kitani above),
wherein the collar abutment portion CA (see annotated Fig. 8 of Kitani above) is arranged between the main “MA” and the auxiliary abutment portions “AA” (see annotated Fig. 8 of Kitani above) of the first male connector 22 (Fig. 8 of Kitani) into said recess 31a (see annotated Fig. 8 of Kitani above – the collar abutment portion CA is located within the cavity 31a, which is between the main abutment portion MA and the auxiliary abutment portion AA), and
wherein the collar 28 (Fig. 8 of Kitani) is axially movable with respect to the first male connector 21 (Fig. 8 of Kitani) by an amount proportional to the distance “D” (see annotated Fig. 3 of Kitani above – distance “D”) between the main “MA” and the auxiliary abutment portions “AA” of the first male connector 22 (see annotated Fig. 8 of Kitani above, and Par. 28 of Kitani – “More specifically, the size of luer-locking fitting member 28 is provided so that… the base 28a is engaged in concavity 31a of main joint part 31 such that it can slide in contact with it”).
Regarding claim 25, Kitani in view of Carrez discloses the invention of claim 20. Kitani in view of Carrez further discloses wherein the first fluid coupling portion 32 (Fig. 4 of Kitani) of the first male connector 22 (Fig. 4 of Kitani) includes a tip portion 32 (Fig. 4 of Kitani) defining an internal channel (Fig. 4 of Kitani – the hollow center of main connector unit 32) for fluid transport (Par. 2 of Kitani – the intended use of the invention is for medicinal solution or blood flow), said tip portion 32 (Fig. 4 of Kitani) having a tapered external surface (Par. 25 of Kitani – “The outer circumferential surface of luer member 32 is formed as a gently tapering surface”),
wherein the second fluid coupling portion 23 (Fig. 4 of Kitani) of the second female connector 21 (Fig. 4 of Kitani) includes a terminal portion (Fig. 4 of Kitani – right-most end of female connector 21) defining an internal channel 23a (Fig. 4 of Kitani – internal circumferential surface 23a) for fluid transport (Par. 2 of Kitani – the intended use of the invention is for medicinal solution or blood flow), said terminal portion of the second female connector 21 (Fig. 4 of Kitani – the right-most end of female connector 21) having a tapered internal surface counter shaped (Par. 24 of Kitani – “The internal circumferential surface 23a of main connector unit 23 is formed in a gently tapered shape such that the diameter on the aperture side is large and gets smaller as it progresses inward”) to the tapered external surface of the tip portion 32 of the first male connector 22 (Fig. 4 of Kitani, and Par. 25 of Kitani – “The outer circumferential surface of luer member 32 is formed as a gently tapering surface with a large diameter at the base that grows smaller moving toward the tip, such that it can be engaged with the internal circumferential surface 23a of main connector unit 23”), and
wherein at least part of the tip portion 32 (Fig. 4 of Kitani) of the first male connector 22 (Fig. 4 of Kitani) is configured to enter into the terminal portion of the second female connector 21 (Fig. 8 of Kitani, and Par. 32 of Kitani – “the tip aperture of female connector 21 and the tip aperture of male connector 22 are caused to face each other and are then brought close together. Then the luer member 32 of male connector 22 is placed inside female connector 21”),
wherein said tapered external surface coupling to said tapered internal surface 23a (Fig. 8-9 of Kitani) connects the first male 22 and second female connectors 21 (Fig. 8-9 of Kitani) in a fluid tight manner (Par. 33 of Kitani – “female connector 21 and male connector 22 are linked to form a passage in a suitably connected condition that will not give rise to liquid leakage”).
Regarding claim 26, Kitani in view of Carrez discloses the invention of claim 20. Kitani in view of Carrez further discloses wherein the collar 28 (Fig. 4 of Kitani) comprises a main body 28 (Fig. 4 of Kitani) having a tubular shape (Par. 28 of Kitani – “The luer-locking fitting member 28 is formed in an approximately cylindrical shape”) extending between a first opening O1 and a second opening O2 (see annotated Fig. 5 of Kitani below),
wherein the first opening O1 (see annotated Fig. 5 of Kitani below) is configured to receive the second coupling portion 23 (Fig. 4 of Kitani), the second hooking portion 25 (Fig. 8-9 of Kitani) and the at least one second locking projection 25a (Fig. 3a of Carrez; Examiner notes that once the modification is made as discussed in claim 20, the locking projection 25a of Carrez will substitute the locking projection 26 of Kitani; thus, the limitation is met) of the second female connector 21 (see annotated Fig. 5 of Kitani below, and Fig. 8-9 of Kitani),
wherein the second opening O2 (see annotated Fig. 5 of Kitani below) is configured to receive the first male connector 22 (Fig. 4 of Kitani), wherein when the first male connector 22 (Fig. 4 of Kitani) is inserted within the second opening O2 (Fig. 4 of Kitani and see annotated Fig. 5 of Kitani below), the second opening O2 (see annotated Fig. 5 of Kitani below) is arranged at a recess 31a (Fig. 5 of Kitani – concavity 31a) of the first male connector 22 (Fig. 4-5 of Kitani) to allow coupling (Par. 28 of Kitani) and a collar abutment portion CA (see annotated Fig. 8 of Kitani above) that extends radially inwardly is arranged at the second opening O2 (see annotated Fig. 5 of Kitani below and annotated Fig. 8 of Kitani above – the collar abutment portion CA is at the second opening O2 and extends inward circumferentially), and
wherein the collar 28 (Fig. 4 of Kitani) externally surrounds at least part of the first male connector 22 (Fig. 4-5 of Kitani, and Par. 25 of Kitani – “male connector 22 is structured with an approximately tubular joint part 27, and a luer-locking fitting member 28 that is attached to the outer circumference of joint part 27”) and the main body 28 of the collar 28 is coaxial with the first male connector 22 (Fig. 4-5 of Kitani – both share the same axial axis).
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Annotated Fig. 5 of Kitani
Regarding claim 27, Kitani in view of Carrez discloses the invention of claim 26. Kitani in view of Carrez further discloses wherein:
said at least first one locking projection 33 (Fig. 4b of Carrez) of the collar 28 (Fig. 4 of Kitani) is arranged at an inlet of the first opening O1 (see annotated Fig. 5 of Kitani above, Fig. 4 of Kitani, and Par. 29 of Kitani – “The passive engagement member 35 is structured with a projecting member 35a provided at the tip of internal circumferential surface of luer-locking fitting member 28”; Examiner notes that once the modification is made as discussed in claim 20, the locking projection 33 of Carrez will substitute the locking projection 35 of Kitani without locational changes; thus, the limitation is met), said first hooking portion 34 (Fig. 4 of Kitani) of the collar 28 (Fig. 4 of Kitani) is interposed between said at least one second locking projection 33 (Fig. 4b of Carrez) and the second opening O2 (see annotated Fig. 5 of Kitani above) of the collar 28 (see annotated Fig. 5 of Kitani above and Fig. 4 of Kitani – locking projection 33 of Carrez and second opening O2 sandwich the female threads 34 upon modification as discussed in claim 20); and
the second hooking portion 25 (Fig. 4 of Kitani) of the second female connector 21 (Fig. 4 of Kitani) is interposed between the at least one second locking projection 25a (Fig. 3a of Carrez) and a terminal portion of the second coupling portion 23 (Fig. 4 of Kitani; Examiner notes that once the modification is made as discussed in claim 20, the locking projection 25a of Carrez will substitute the locking projection 26 of Kitani without locational changes; thus, the limitation is met) of the second female connector 21 (Fig. 4 of Kitani – the annular engagement projection 26, now overthickness 25a of Carrez upon modificaiton, and the right-most end of main connector unit 23 sandwich the male threads 25);
wherein the first hooking portion 34 (Fig. 4 of Kitani) of the collar 28 (Fig. 4 of Kitani) and the second hooking portion 25 (Fig. 4 of Kitani) of the second female connector 21 (Fig. 4 of Kitani) both comprise:
respective threads 25, 34 (Fig. 4 of Kitani – male threads 25 and female threads 34) configured to engage each other, through the engagement rotation, to define the engaged configuration (Par. 29 of Kitani – “female threads 34 that can screw to the male threads 25 of female connector 21…”).
Regarding claim 31, Kitani in view of Carrez discloses the invention of claim 30. Kitani in view of Carrez further discloses wherein the socket teeth 25, 33 (Fig. 3a of Carrez, and Fig. 4b of Carrez) of both the second female connector 21 (Fig. 4 of Kitani) and the collar 28 (Fig. 4 of Kitani) radially define recesses 25c, 33c (Fig. 3a and Fig. 4b of Carrez – guide edges 25c, 33c) and protrusions 25b, 33b (Fig. 3a and Fig. 4b of Carrez – locking edges 25b, 33b) alternately (Fig. 3a and Fig. 4b of Carrez),
wherein the second female connector 21 (Fig. 4 of Kitani) defines a maximum external diameter of encumbrance (Fig. 3b and Fig. 5d of Carrez – the cross-sectional view shows the largest external diameter of teeth 25) measured at the protrusions 25b (Fig. 3a of Carrez) of the socket teeth 25 (Fig. 3a-3b and Fig. 5d of Carrez),
wherein the collar 28 (Fig. 4 of Kitani) has a tubular shape (Fig. 4 of Kitani) and presents a minimum internal diameter (Fig. 5c-5d of Carrez – the cross-sectional view shows the minimum internal diameter of notch 33 at edge 32a) measured at the protrusions 33b (Fig. 4b of Carrez) of the socket teeth 33 (Fig. 4b and Fig. 5d of Carrez) of the collar 28 (Fig. 4 of Kitani),
wherein the maximum external diameter of encumbrance is higher than said minimum internal diameter (Fig. 5d of Carrez – the external diameter is larger than the internal diameter) so that, when the socket teeth 25 (Fig. 3a of Carrez) of the second female connector 21 (Fig. 4 of Kitani) are in contact with the socket teeth 33 (Fig. 4b and Fig. 5d of Carrez) of the collar 28 (Fig. 4 of Kitani), the protrusions 25b (Fig. 3a of Carrez) of the socket teeth 25 (Fig. 3a of Carrez) of the second female connector 21 (Fig. 4 of Kitani) are inserted into the recesses 33c (Fig. 5d of Carrez) of the socket teeth 33 (Fig. 5d of Carrez) of the collar 28 (Fig. 4 of Kitani) and vice versa.
Examiner notes that once the combination is made as discussed in claim 20, the construct of the first and second locking portions comprising the socket teeth with protrusions and recesses of Carrez will be incorporated into the device of Kitani. Thus, the limitation is met.
Regarding claim 32, Kitani in view of Carrez discloses the invention of claim 20. Kitani in view of Carrez further discloses wherein the first male connector 22 (Fig. 4 of Kitani) and the collar 28 (Fig. 4 of Kitani) are two separate pieces that may be subsequently axially coupled (cross-sectional Fig. 4 of Kitani shows no integral borders between the collar 28 and male connector 22), the collar 28 (Fig. 4 of Kitani) being free to rotate with respect to the first male connector 22 (Par. 25 of Kitani – “a luer-locking fitting member 28 that is attached to the outer circumference of joint part 27 and can rotate circumferentially about the axis of joint part 27”) at least when the female second connector 21 (Fig. 4 of Kitani) is not coupled to the collar 28 (Fig. 4 of Kitani – non-coupling configuration) and to the first male connector 22 (Fig. 4 of Kitani and Par. 28 of Kitani) and
wherein, when the non-removable connection system 20 (Fig. 1 of Kitani) is disposed in the engaged configuration (Fig. 9 of Kitani), at least part of the second coupling portion 23 (Fig. 9 of Kitani) of the second female connector 21 (Fig. 9 of Kitani) is interposed between the collar 28 (Fig. 9 of Kitani) and at least part of the first coupling portion 32 (Fig. 4 of Kitani and Fig. 9 of Kitani) of the first male connector 22 (Fig. 9 of Kitani – main connector unit 23 is sandwiched between the collar 28 and the luer member 32).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Kitani in view of Carrez as applied to claim 20 above, and further in view of Jensen et al. US 2014/0243797 A1 (previously cited, hereinafter Jensen), as cited in the IDS.
Regarding claim 33, Kitani in view of Carrez discloses the invention of claim 20. Kitani in view of Carrez further discloses comprising a fluid line 10 (Fig. 1 of Kitani – line set 10), wherein
the first male connector 22 (Fig. 1 of Kitani) extends in length between the first coupling portion 32 (Fig. 4 of Kitani) and a first connection port 17 (Fig. 1 – tube 17 of Kitani); and
the second female connector 21 (Fig. 1 of Kitani) extends in length between the second coupling portion 23 (Fig. 2 of Kitani) and a second connection port 16 (Fig. 1 of Kitani – tube 16).
However, Kitani in view of Carrez does not explicitly disclose a fluid line of a medical machine, wherein the first connection port is fixed to an end of said fluid line of the medical machine, wherein the second connection port is fixed to an end of said fluid line of the medical machine.
Jensen, in the same field of endeavor of fluid line connector (Title), teaches a fluid line 118, 122 (Fig. 1 – fluid line 118, catheter assembly 122) of a medical machine 100 (Fig. 1 – extracorporeal hemodialysis circuit 100), wherein the first connection port 22 (Fig. 2 – tubing connection portion 22) is fixed to an end of said fluid line 118 (Fig. 1-2) of the medical machine 100 (Fig. 1), wherein the second connection port 146 (Fig. 2 – tubing connection port 146) is fixed to an end of said fluid line 122 (Fig. 1-2) of the medical machine 100 (Fig. 1).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have applied the fluid line of Kitani in view of Carrez to be in use with a medical machine as taught by Jensen, as connectors are well-known to be used to connect fluid lines to needles, syringes, catheters, fluid reservoirs, laboratory instruments, and other medical devices, including hemodialysis treatments (Par. 3 of Jensen). Providing such connector of Kitani in view of Jensen will provide a leak-free connection in fluid lines (Par. 3 of Jensen), which improves safety and treatment quality for patients.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hallisey et al. US 2017/0036007 A1 teaches various medical connector assemblies with a female fitting, male fitting, and a collar.
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 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
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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