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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/01/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment and argument filed on 10/01/2025. As directed by the amendment: claims 2-3, 5, 8-11, and 19 have been amended, claims 4, 6-7, 12-14, and 16-18 have been cancelled, and claims 22-25 have been added. Thus, claims 1-3, 5, 8-11, 15, and 19-25 are presently pending in this application, with no claims being withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Regarding claim 1, the phrase “and an unlocked conditions” in lines 16-17 should read “and an unlocked condition” for proper grammar,
Regarding claim 1, the phrase “by resilient abutment of the at least one flexible wing of the at least one ramp” in lines 19-21 should read “by resilient abutment of the at least one flexible wing with the at least one ramp” for clarity,
Regarding claim 5, the phrase “progressively up each the at least one ramp” in lines 2-3 should read “progressively up the at least one ramp” for clarity as the “each” is improper grammar and redundant,
Appropriate correction is required.
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.
Claim(s) 1-3, 8, 10-11, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Yalcin et al. (EP Patent No. 2174053, “Yalcin”) in view of Daimon et al. (U.S Patent Pub. No. 20130154255 A1, “Daimon”).
Regarding claim 1, Yalcin discloses the limitations of (Claim 1) a dialyser connector (1, see at least Fig. 1-3a and para. 0001 – the connector element 1 is capable of being configured as a connector used for a dialyser) comprising: a main body (11, see Fig. 3a), and a sliding clip (12, see Fig. 4a-4c), wherein: the main body (11) includes a tube end (112) and a dialyser end (111, see Fig. 3b, para. 0011 and 0014 – the two ends of the main body 11 are capable of being configured to couple with a tube and a dialyser), the main body (11) defines a cavity (cavity formed by 120), at least one aperture (120) and at least one ramp (118, see Fig. 3a-3c, see para. 0012 – apertures 120 form a cavity extending external the main body 11 to internal the main body 11, see para. 0026 – ears 118 have an inclined surface along which wings 124 travel and are thus interpreted as a ramp), the sliding clip (12) includes a tube end and a dialyser end (see Fig. 4a and 5a and annotated Yalcin drawing 1 below for sliding clip ends – the axes show the positive and negative “010” direction, the end of clip 12 oriented in the “010” direction is the tube end and the end oriented in the “-010” direction is the dialyser end as is consistent with the ends of the
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main body 11),
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the sliding clip (12) includes a spine (121) connecting the tube end and the dialyser end (see Fig. 4a and para. 0015), the sliding clip (12) includes at least one flexible wing (124) and at least one arm (122, see Fig. 4a-4c and para. 0015), the at least one flexible wing (124) extending in an arc from the spine (121, see annotated Yalcin drawing 2 below for arc, see Fig. 4b and para 0015 – wing 124 including portion 122c together form an arc shape as annotated below that extends from spine 121), the at least one arm (122) extending in an arc from the spine (121, see annotated Yalcin drawing 2 below for arc, see Fig. 4c and para. 0015 – arm 122 formed from portions 122c and 122b together form an arc shape as annotated below that extends from spine 121),
the at least one arm (122) includes at least one first projection (122a) extending radially inward (see Fig. 4a and 4c and para. 0018), the dialyser connector (1) includes a locked condition in which the at least one first projection (122a) extends into the cavity (cavity formed by 120) of the main body (11) and an unlocked conditions in which the at least one first projection (122a) is withdrawn from the cavity (cavity formed by 120) of the main body (11, see Fig. 5c-5d for locked position, see para. 0021 and 0023 – the assembled position is interpreted as the locked position with projection 122a extending into cavity of aperture 120, see Fig. 8d-8e for unlocked position, see para. 0024), the at least one first projection (122a) is biased to the locked condition by resilient abutment of the at least one flexible wing (124) of the at least one ramp (118, see Fig. 5d and 8e and para. 0021 – wing 124 resiliently abuts the inclined surface of ramp 118 as the projection 122a is within cavity formed by 120 and requires a force to overcome the biasing force).
However, Yalcin fails to disclose (Claim 1) the spine defining a notch, the main body includes a second projection, and the second projection extends through the notch and is visible along the spine with the dialyser connector in the locked condition.
Daimon discloses a pipe fitting (10) having one end coupled to a connector (13) and the other coupled to a pipe (100), wherein the pipe fitting (10) comprises a main body portion (15) and a sliding clip (14, see Fig. 1 and para. 0046 and 0050-0051). Daimon teaches (Claim 1) the spine (14A) defining a notch (54, see Fig. 3A-3B), the main body (15) includes a second projection (34, see Fig. 1), and the second projection (34) extends through the notch (54) and is visible along the spine (14A) with the dialyser connector (10) in the locked condition (see Fig.1, 3A, and para. 0062 – upon insertion of the clip 14 into the main body 15 to be fully mounted and thus in the locked condition, the projection 34 would extend through the notch 54 and be visible along spine 14A as seen from the top view in Fig. 3A).
Therefore, 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 spine of the safety clip and the main body taught by Yalcin to have a notch and a second projection, respectively, such that the second projection extends through the notch and is visible along the spine when the connector is in the locked condition as taught by Daimon. This modification is motivated as Daimon teaches the notch and second projection prevent the sliding clip from being inserted in the wrong orientation (see para. 0062). In combination, the spine (121) of the safety clip (12) of Yalcin would be modified to have a notch and the main body (11) of Yalcin would be modified to have a second projection, such that in the locked position (see Fig. 5a), the second projection would extend through the notch and be visible along the spine (121) of Yalcin.
Regarding claim 2, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Yalcin discloses (Claim 2) wherein the at least one first projection (122a) comprises a pair of first projections and wherein the at least one aperture (120) comprises a pair of apertures (see Fig. 4a-4c for pair of projections 112a, see Fig. 3a and 8d for pair of apertures 120).
Regarding claim 3, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Yalcin discloses (Claim 3) wherein the at least one arm (122) includes a hook configured to abut a shoulder of the main body (11) to prevent detachment of the sliding clip (12) from the main body when assembled (see Fig. 5c and annotated Yalcin drawing 3 below – the upper limit of the aperture 120 of main body 11 forms a shoulder in which the hook of arm 122 is capable of being configured to abut if the clip 12 was pulled in the upwards “001” direction and thus prevent detachment of clip 12 from main body 11).
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Regarding claim 8, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Yalcin discloses (Claim 8) further comprising a seal (14, see Fig. 2 and see para. 0009).
Regarding claim 10, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Yalcin discloses (Claim 10) wherein the dialyser connector (1) is symmetrical about a centered vertical plane (see Fig. 4a-4c).
Regarding claim 11, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Yalcin discloses (Claim 11) wherein the dialyser connector (1) is single use, and comprises plastic (see para. 0011 for plastic, examiner notes the connector 1 may be capable of being configured for single-use).
Regarding claim 20, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Daimon discloses (Claim 20) wherein the notch (54) circumscribes the second projection (34) with the dialyser connector (10) in the locked condition (see Fig.1, 3A, and para. 0062 – upon insertion of the clip 14 into the main body 15 to be fully mounted and thus in the locked condition, the notch 54 would circumscribe the projection 34 as they are a key and lock fit).
Regarding claim 21, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Yalcin discloses the main body (11) is symmetric about a centered, vertical plane (see Fig. 3a-3c).
In modified Yalcin, Daimon discloses the second projection (34) centered on the top surface of the main body (15, see Fig. 2A).
Thus, in combination, the second projection would be centered on the top surface of the main body of Yalcin, and modified Yalcin would disclose (Claim 21) wherein the main body is symmetric about a plane extending through the second projection of the main body.
Regarding claim 22, modified Yalcin discloses the dialyser connector of claim 21, as discussed above. In modified Yalcin, the second projection (34) of Damion would be centered on the top surface of the main body (11) of Yalcin, and the sliding clip (12) of Yalcin is centered over the main body (11) of Yalcin (see Fig. 5a-5d). Thus, in combination, modified Yalcin discloses (Claim 22) the sliding clip (12) is symmetric about the plane extending through the second projection of the main body (11) with the dialyser connector (1) in the locked condition (see Fig. 5c-5d for locked condition).
Regarding claim 23, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Daimon discloses (Claim 23) wherein the notch (54) is defined along the dialyser end of the sliding clip (14, see Fig. 1, examiner is interpreting the end of clip 14 oriented towards the connector 13 as the tube end and the end of clip 14 oriented towards the pipe 100 as the dialyser end).
Claim(s) 5 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Yalcin in view of Daimon as applied to claim 1 above, and further in view of Daoud et al. (U.S Patent Pub. No. 20180238479 A1, “Daoud”).
Regarding claim 5, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Yalcin discloses (Claim 5) the at least one flexible wing (124) movable progressively up each the at least one ramp (118) such that the sliding clip (14) moves downward relative to the main body (11) in response to pressure on the spine (121) with the dialyser connector (1) in the locked condition (see Fig. 5d and 8e and para. 0024 – when the connector 1 is in the locked condition, a pressure may be applied to spine 121 which progressively moves the wings 124 up the incline surface of the ramp 118 to thus move the clip 12 downward relative to main body 11).
However, modified Yalcin fails to disclose (Claim 5) wherein the spine includes a depression, where pressure is applied to the depression of the spine.
Daoud discloses a quick connector (2) having a tube end (7) and an opposite end for coupling with a connector (see Fig. 5-8 and para. 0003), wherein the connector (2) comprises a main body (2) and a sliding clip (60). Daoud teaches (Claim 5) wherein the spine (64) includes a depression, where pressure is applied to the depression of the spine (64, see Fig. 12 and para. 0044 – spine 64 of clip 60 comprises a plurality of ridges and depressions where a pressure is applied to the clip 60).
Therefore, 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 spine of the safety clip taught by Yalcin to have a plurality of depressions as taught by Daimon to thus indicate visually and tactically to the user the location for the pressure to be applied and provide more grip (see para. 0044).
Regarding claim 25, modified Yalcin discloses the dialyser connector of claim 5, as discussed above. In modified Yalcin, Yalcin discloses the dialyser connector (1) is in an unlocked position in response to a pressure on the spine (121, see para. 0024).
In modified Yalcin, Daimon discloses wherein the second projection (34) provides a visual indication that the dialyser connector (10) is in an unlocked condition (14A, see Fig. 1 and para. 0062 – when the clip 14 is in the unlocked position, the second projection 34 will be visible outside the notch 56 and thus indicate that the connector 10 is unlocked).
Thus, in combination, modified Yalcin discloses (Claim 25) when a user applies a pressure to the depressions of Daoud modified onto the spine (121) of modified Yalcin, the connector (1) of Yalcin will be moved to the unlocked position and the second projection taught by Daimon would thus be visible to indicate such.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yalcin in view of Daimon as applied to claim 8 above, and further in view of Packham (W.O Patent Pub. No. 2015103499 A1).
Regarding claim 9, modified Yalcin discloses the dialyser connector of claim 8, as discussed above. In modified Yalcin, Yalcin discloses the seal (14).
However, modified Yalcin fails to disclose (Claim 9) wherein the seal comprises an overmould on the main body.
Packham discloses a fluid coupler system comprising a connector (1), wherein the connector (1) comprises a seal in comprising an overmolded O-ring (79) on the main body (914, see Fig. 12A-12B, and p.16, lines 20-25).
Therefore, 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 O-ring taught by modified Yalcin to be an overmolded O-ring as taught by Packham. This modification is motivated as Packham teaches that an overmolded O-ring may provide improved sealing characteristics (see p.13, lines 15-17).
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Beden et al. (U.S Patent Pub. No. 20050230292 A1, “Beden”) in view of Yalcin in view of Daimon.
Regarding claim 15, Beden discloses the limitations of (Claim 15) a dialysate mixing and pumping cartridge (10, see Fig. 1) comprising dialyser connector (see Fig. 1 and para. 0027 – line 18 leads to the dialyser and has a tube connector not shown).
However, Beden fails to disclose the dialyser connecter of claim 1.
Yalcin in view of Daimon disclose the dialyser connector of claim 1, as discussed above.
Therefore, 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 connector taught by Beden to be substituted with the connector taught by modified Yalcin. Modified Yalcin teaches an improved quick connector for connecting two flexible conduits which is easily mountable when incorporating a siphon therebetween the conduits, lockable, and maintains an impermeable and sealed connection in the locked position (see para. 0001-0002).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Yalcin in view of Daimon as applied to claim 8 above, and further in view of Trotter et al. (U.S Patent Pub. No. 20170356581 A1, “Trotter”).
Regarding claim 19, modified Yalcin discloses the dialyser connector of claim 8, as discussed above. In modified Yalcin, Yalcin discloses the limitations of (Claim 19) the seal (14) comprises an O-ring seal adjacent the tube end (112) of the main body (11, see Fig. 3b and 7) and insertable into the connector (1) via the dialyser end (111) of the main body (11, see Fig. 3b and 7, and para. 0011 – O-ring 14 is insertable into the connector 1 via the end 111).
However, modified Yalcin fails to disclose (Claim 19) wherein an inside surface of the main body defines an annular recess adjacent the tube end of the main body, and the seal comprises an O-ring seal insertable into the annular recess via the dialyser end of the main body.
Trotter discloses a quick connector assembly (10) comprises a main body (14), wherein Trotter teaches (Claim 19) wherein an inside surface (inner surface of 14) of the main body (14) defines an annular recess (18, see Fig. 1 and para. 0015).
Therefore, 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 inner surface of the main body taught by modified Yalcin to have an annular recess for seating the O-ring as taught by Trotter. The modification is motivated as Trotter teaches that a groove in combination with a retaining ring substantially block the O-ring from axial movement, and the groove allows the O-ring to expand radially outward when the connector is in use (see para. 0015-0016).
In combination, modified Yalcin would be modified to have an annular recess at the location of the O-ring (14) seen in Fig. 7. Thus, modified Yalcin discloses an annular recess adjacent the tube end (112, see Fig. 3b and Fig. 7), and an O-ring (14) insertable into the annular recess.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Yalcin in view of Daimon as applied to claim 1 above, and further in view of Corbett et al. (U.S Patent No. 5683117, “Corbett”).
Regarding claim 24, modified Yalcin discloses the dialyser connector of claim 1, as discussed above. In modified Yalcin, Yalcin discloses the limitations of (Claim 24) the at least one wing (124) and the at least one arm (122) are separated from one another (see Fig. 4a-4c).
However, modified Yalcin fails to disclose (Claim 24) the at least one wing and the at least one arm are separated from another by a respective cut-out.
Corbett discloses a connector comprising a main body (46) and sliding clip (1, see Fig. 4-5), wherein Corbett teaches (Claim 24) the at least one wing and the at least one arm (3) are separated from another by a respective cut-out (12, see annotated Corbett drawing 1 below for wing, see Fig. 2 and Col.3, lines 30-42 for cut-out 12).
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Therefore, 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 at least one wing and the at least one arm taught by modified Yalcin to be separated by a respective cut-out as taught by Corbett. The modification is motivated as Corbett teaches that providing a recess between the wing and the arm allows for increased flexibility between the two (see Col.3, lines 38-42).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY B FREDRICKSON/Primary Examiner, Art Unit 3783