DETAILED ACTION
The RCE filed 3 February 2026 has been entered. Claims 1-2, 4-8, 10-12, 14-16, 18-20, and 23-26 are pending, with claims 24-26 being new. Claims 3, 9, 13, 17, 21-22 have been cancelled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 February 2026 has been entered.
Response to Arguments
Applicant's arguments filed 3 February 2026 have been fully considered but they are not persuasive for the following reasons in view of prior art references – Ira et al. (US 9,752,714) and Fitzgibbons (US 4,834,139).
The applicant argues with respect to claims 1, 19, and 20 on pgs. 9-14 of the Response that it wouldn’t be obvious to modify the second connector 9 in Ira to include a protruding ring to restrict the output portion of the second connector 9 from being inserted through the second end of the first connector 2 because the second connector 9 already fits inside the first connector 2, and “such a modification would change Ira’s principle of operation by inhibiting the ability of a user to ‘insert[] the coupler (9) into a tubular chamber (15) of the coupler body (2).” However, Fitzgibbons teaches in Figs. 1-2 a similar second connector 14 that fits inside a first connector 12, wherein the second connector 14 includes a protruding ring 50 with which the first connector 12 abuts when the connectors 12, 14 are coupled together (col. 3, lines 33-37), such that the output portion of the second connector 14 is restricted from being inserted through the second end of the first connector 12. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second connector disclosed by Ira to include a protruding ring disposed between the coupling portion and the output portion to restrict the output portion from being inserted through the second end of the first connector, as Fitzgibbons teaches (col. 3, lines 33-37), wherein the protruding ring also provides a clear limit stop and indication of the relative positions of the connectors for securing them together.
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).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the plurality of grooves on the mating portion of the first connector, claimed in claim 25 as corresponding to plural positions at which the coupling portion on the second connector is secured within the mating portion, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 25 is objected to because of the following informalities: In claim 25, line 2, it is suggested that “comprising” be changed to --corresponding to-- to more accurately describe the relationship of the grooves and the relative positions of the connectors.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 26 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 26, it is unclear how “the protruding ring 157 abuts an outer edge of the channel 164 [antecedently recited as being on the second connector 140] when the first connector 102 is coupled to the second connector 140.” As understood from paragraph 80, the recited channel is meant to recite a channel 134 on the first connector 102.
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.
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 1-2, 4-8, 10-12, 14-16, 18-20, 23-24, and 26 (as understood: 26) are rejected under 35 U.S.C. 103 as being unpatentable over Ira et al. (US 9,752,714) in view of Raines et al. (US 2004/0195538) and Fitzgibbons (US 4,834,139).
Regarding claim 1, Ira discloses in Figs. 10A-B a coupler comprising:
a first connector 2 having a first end (with tubular member 30);
a second end (toward second connector 9) opposite the first end;
a first opening 8; and
a first valve 3 disposed between the first end and the second end, the first valve 3 having a compressed state (when the biasing spring 24 is compressed) and an expanded state (when the biasing spring 24 is naturally expanded to seat valve element 3 onto seat 5 to close the first opening 8), the first valve 3 extending at least partially through the first opening 8 when the first valve 3 is in the expanded state; and
a second connector 9 having:
a coupling portion (that fits inside the first connector 2) configured to be disposed within at least a portion of the first connector 2,
a second opening 14;
an output portion comprising a tube 50;
and
a second valve 10 disposed at least partially within the coupling portion, the second valve 10 having a compressed state (when the biasing spring 48 is compressed) and an expanded state (when the biasing spring 48 is naturally expanded to seat valve element 10 onto seat 12 to close the second opening 14), the second valve 10 extending at least partially through the second opening 14 when the second valve 10 is in the expanded state,
wherein when the first connector 2 receives at least the portion of the coupling portion, the first connector 2 detachably couples to the second connector 9 such that the coupling portion of the second connector 9 extends through the second end of the first connector 2, and the first valve 3 and the second valve 10 are in the compressed state when the first connector 2 is coupled to the second connector 9 such that a fluid pathway is formed through the first connector 2 and the second connector 9 (Fig. 10A),
wherein the first connector 2 is configured to decouple from the second connector 9 in response to a pullout force exceeding a predetermined threshold force (because the detent 68 comprising groove 69 in the first connector 2 is for “releasable fixed axial positioning of the coupler insert (9) inside of the tubular chamber (15),” as disclosed in col. 8, lines 58-67, via radially extending members 70 on the second connector 9 fitting into the groove 69 on the first connector 2, as disclosed in col. 9, lines 1-18).
Ira lacks the second connector comprising: a channel that extends through the tube of the output portion; and a protruding ring disposed between the coupling portion and the output portion to restrict the output portion from being inserted through the second end.
With regard to the channel, Raines teaches Figs. 1-3 (specifically the embodiment in Fig. 3) a second connector 10 having a coupling portion 12, a second opening 24, an output portion 18 comprising a tube 70, and a channel 60 that extends through the tube 70.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the output portion of the second connector disclosed by Ira to comprise a tube and a channel that extends through the tube so that output portion comprises a standard medical luer that allows the coupler to be used with common medical devices, as Raines teaches (paragraph 27).
With regard to the protruding ring, Fitzgibbons teaches in Figs. 1-2 a protruding ring 50 disposed between the coupling portion (with port 60 that fits into the first connector 12) and the output portion (with port 58) to restrict the output portion from being inserted through the second end of the first connector 12.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second connector in the combination of Ira and Raines to include a protruding ring disposed between the coupling portion and the output portion to restrict the output portion from being inserted through the second end, as Fitzgibbons teaches (col. 3, lines 33-37), wherein the protruding ring also provides a clear limit stop and indication of the relative positions of the connectors for securing them together.
Regarding claim 2, Ira discloses in Figs. 10A-B that the first valve 3 seals the first opening 8 when the first valve 3 is in the expanded state (Fig. 10B), and the second valve 10 seals the second opening 14 when the second valve 10 is in the expanded state (Fig. 10B).
Regarding claim 4, Ira discloses in Figs. 10A-B that the first connector 2 includes a first biasing element 24 coupled to the first valve 3, the first biasing element 24 having an expanded state and a compressed state (corresponding to the expanded and compressed states of the first valve 3, respectively).
Regarding claim 5, Ira discloses in Figs. 10A-B that the first biasing element 24 being in the expanded state results in the first valve 3 being in the expanded state and the first biasing element 24 being in the compressed state results in the first valve 3 being in the compressed state.
Regarding claim 6, Ira discloses in Figs. 10A-B that the second connector 9 includes a second biasing element 48 coupled to the second valve 10, the second biasing element 48 having an expanded state and a compressed state (corresponding to the expanded and compressed states of the second valve 10, respectively).
Regarding claim 7, Ira discloses in Figs. 10A-B that the second biasing element 48 being in the expanded state results in the second valve 10 being in the expanded state and the second biasing element 48 being in the compressed state results in the second valve 10 being in the compressed state.
Regarding claim 8, Ira discloses in Figs. 10A-B that the pullout force is a force applied to the first connector 2 along a central axis of the first connector 2 and the central axis extends at least along a length of the first connector 2 (because one having ordinary skill in the art would recognize such a method of use would be able to be performed on the prior art structure) and extends through the first connector 2 and the second connector 9 when the first connector is 2 coupled to the second connector 9.
Regarding claim 10, Ira discloses in Figs. 10A-B that the first valve 3 includes a first substantially planar surface (at the end of tip 7) and the second valve 10 includes a second substantially planar surface (at the end of tip 13), the first substantially planar surface configured to contact the second substantially planar surface when the first connector 2 is coupled to the second connector 9 (Fig. 10A).
Regarding claim 11, Ira discloses in Figs. 10A-B that the first valve 3 exerts a pressure on the second valve 10 causing the second valve 10 to be in the compressed state when the first connector 2 is coupled to the second connector 9 (Fig. 10B).
Regarding claim 12, Ira discloses in Figs. 10A-B that the first valve 3 at least partially extends through the first opening 8 to seal the first opening 8 and the second valve 10 at least partially extends through the second opening 14 to seal the second opening 14 when the first connector 2 is decoupled from the second connector 9 (Fig. 10B).
Regarding claim 14, Ira discloses in Figs. 10A-B that the first connector 2 includes a mating portion (comprising the second end facing the second connector 9 and/or a portion thereof, such as chamber 15) opposite the first end and configured to receive the coupling portion of the second connector 9 when the first connector 2 is coupled to the second connector 9.
Regarding claim 15, Ira discloses in Figs. 10A-B that the first valve 3 and the second valve 10 are in the expanded state when the first connector 2 is disconnected from the second connector 9 (Fig. 10B).
Regarding claim 16, Ira discloses in Figs. 10A-B that the first connector 2 is configured to remain coupled to the second connector 9 when the pullout force does not exceed the predetermined threshold force (because the detent 68 comprising groove 69 in the first connector 2 is for “releasable fixed axial positioning of the coupler insert (9) inside of the tubular chamber (15),” as disclosed in col. 8, lines 58-67, via radially extending members 70 on the second connector 9 fitting into the groove 69 on the first connector 2, as disclosed in col. 9, lines 1-18).
Regarding claim 18, Ira discloses in Figs. 1A-B and 10A-B that the first connector 2 is coupled to a first portion of tubing 37 at the first end and the second connector 9 is coupled to a second portion of tubing 57 at an output portion (because one having ordinary skill in the art would recognize that the end of the second connector 9 to which the tubing 57 is attached can be the outlet or the inlet, and the coupler would function the same, regardless of the direction of flow).
Regarding claim 19, Ira discloses in Figs. 1A-B and 10A-B a coupler comprising:
a first connector 2 having a first end (with tubular member 30), a second end (toward second connector 9) opposite the first end, a mating portion (comprising the second end facing the second connector 9 and/or a portion thereof, such as chamber 15) disposed proximate the second end, a first opening 8 disposed between the first end and the second end, a biasing element 24 disposed within the first connector 2, and a first valve 3 coupled to the biasing element 24 and disposed between the first end and the first opening 8, the first valve 3 and the first biasing element 24 having a compressed state and an expanded state, the first biasing element 24 being in the expanded state causes the first valve 3 to be in the expanded state resulting in the first valve 3 at least partially extending through the first opening 8 to seal the first opening 8 (Fig. 10A); and
a second connector 9 having a coupling portion (that fits inside the first connector 2) configured to be disposed within at least a portion of the first connector 2, a biasing element 48 disposed within the second connector 9, a second opening 14, an output portion 50 (because one having ordinary skill in the art would recognize that the end of the second connector 9 to which the tubing 57 is attached can be the outlet or the inlet, and the coupler would function the same, regardless of the direction of flow) comprising a tube, and a second valve 10 coupled to the biasing element 48 and disposed at least partially within the coupling portion, the second valve 10 and the second biasing element 48 having a compressed state and an expanded state, the second biasing element 48 being in the expanded state causes the second valve 10 to be in the expanded state resulting in the second valve 48 at least partially extending through the second opening 14 to seal the second opening 14 (Fig. 10A),
wherein when the mating portion of first connector 2 receives the coupling portion of the second connector 9, the first connector 2 detachably couples to the second connector 9 such that the coupling portion of the second connector 9 extends through the second end of the first connector 2, and the first biasing element 24 being in the compressed state causes the first valve 3 to be in the compressed state and the second biasing element 48 being in the compressed state causes the second valve 10 to be in the compressed state such that a fluid pathway is formed through the first connector 2 and the second connector 9 via the first opening 8 and the second opening 14 (Fig. 10A),
wherein the first connector 2 is configured to decouple from the second connector 9 in response to a pullout force exceeding a predetermined threshold force (because the detent 68 comprising groove 69 in the first connector 2 is for “releasable fixed axial positioning of the coupler insert (9) inside of the tubular chamber (15),” as disclosed in col. 8, lines 58-67, via radially extending members 70 on the second connector 9 fitting into the groove 69 on the first connector 2, as disclosed in col. 9, lines 1-18).
Ira lacks a channel that extends through the tube of the output portion, and a protruding ring disposed between the coupling portion and the output portion to restrict the output portion from being inserted through the second end.
With regard to the channel, Raines teaches Figs. 1-3 (specifically the embodiment in Fig. 3) a second connector 10 having a coupling portion 12, a second opening 24, an output portion 18 comprising a tube 70, and a channel 60 that extends through the tube 70.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the output portion of the second connector disclosed by Ira to comprise a tube and a channel that extends through the tube so that output portion comprises a standard medical luer that allows the coupler to be used with common medical devices, as Raines teaches (paragraph 27).
With regard to the protruding ring, Fitzgibbons teaches in Figs. 1-2 a protruding ring 50 disposed between the coupling portion (with port 60 that fits into the first connector 12) and the output portion (with port 58) and the output portion to restrict the output portion from being inserted through the second end of the first connector 12.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second connector in the combination of Ira and Raines to include a protruding ring disposed between the coupling portion and the output portion to restrict the output portion from being inserted through the second end, as Fitzgibbons teaches (col. 3, lines 33-37), wherein the protruding ring also provides a clear limit stop and indication of the relative positions of the connectors for securing them together.
Regarding claim 20, Ira discloses in Figs. 1A-B and 10A-B a coupler comprising:
a first connector 2 having a first end (with tubular member 30), a second end (toward second connector 9) opposite the first end, an inlet portion disposed proximate the first end (because one having ordinary skill in the art would recognize that the end of the first connector 2 to which the tubing 37 is attached can be the inlet or the outlet, and the coupler would function the same, regardless of the direction of flow), a mating portion (comprising the second end facing the second connector 9 and/or a portion thereof, such as chamber 15) in fluid communication with the inlet portion and disposed proximate the second end, a first opening 8 disposed between the first end and the second end, a first interior space disposed between the first end and the first opening 8, a biasing element 24 disposed within the interior space, and a first valve 3 coupled to the biasing element 24 and disposed between the first end and the first opening 8, the first valve 3 and the first biasing element 24 having a compressed state and an expanded state, the first biasing element 24 being in the expanded state causes the first valve 3 to be in the expanded state resulting in the first valve 3 at least partially extending through the first opening 8 to seal the first opening 8 (Fig. 10A); and
a second connector 9 having a coupling portion (that fits inside the first connector 2) configured to be disposed within at least a portion of the first connector 2, an output portion 50 (because one having ordinary skill in the art would recognize that the end of the second connector 9 to which the tubing 57 is attached can be the outlet or the inlet, and the coupler would function the same, regardless of the direction of flow) extending from the coupling portion and comprising a tube, an interior space disposed within the coupling portion, a biasing element 48 disposed within the interior space, a second opening 14, and a second valve 10 coupled to the biasing element 48 and disposed at least partially within the coupling portion, the second valve 10 and the second biasing element 48 having a compressed state and an expanded state, the second biasing element 48 being in the expanded state causes the second valve 10 to be in the expanded state resulting in the second valve 10 at least partially extending through the second opening 14 to seal the second opening 14 (Fig. 10A),
wherein when the mating portion of the first connector 2 receives the coupling portion of the second connector 9, the first connector 2 detachably couples to the second connector 9 such that the coupling portion of the second connector 9 extends through the second end of the first connector 2 (Fig. 10B), and the first biasing element 24 being in the compressed state causes the first valve 3 to be in the compressed state and the second biasing element 48 being in the compressed state causes the second valve 10 to be in the compressed state such that a fluid pathway is formed through the first connector 2 and the second connector 9 via the first opening 8 and the second opening 14,
wherein the first valve 3 includes a first substantially planar surface (at the end of tip 7), and the second valve 10 includes a second substantially planar surface (at the end of tip 13), the first substantially planar surface configured to contact the second substantially planar surface when the first connector 2 is coupled to the second connector 9 (Fig. 10A),
wherein the first connector 2 is configured to decouple from the second connector 9 in response to a pullout force exceeding a predetermined threshold force (because the detent 68 comprising groove 69 in the first connector 2 is for “releasable fixed axial positioning of the coupler insert (9) inside of the tubular chamber (15),” as disclosed in col. 8, lines 58-67, via radially extending members 70 on the second connector 9 fitting into the groove 69 on the first connector 2, as disclosed in col. 9, lines 1-18), the pullout force being a force applied to the first connector 2 along a central axis of the first connector 2 and the central axis extends at least along a length of the first connector 2.
Ira lacks a channel that extends through the tube of the output portion, and a protruding ring disposed between the coupling portion and the output portion to restrict the output portion from being inserted through the second end.
With regard to the channel, Raines teaches Figs. 1-3 (specifically the embodiment in Fig. 3) a second connector 10 having a coupling portion 12, a second opening 24, an output portion 18 comprising a tube 70, and a channel 60 that extends through the tube 70.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the output portion of the second connector disclosed by Ira to comprise a tube and a channel that extends through the tube so that output portion comprises a standard medical luer that allows the coupler to be used with common medical devices, as Raines teaches (paragraph 27).
With regard to the protruding ring, Fitzgibbons teaches in Figs. 1-2 a protruding ring 50 disposed between the coupling portion (with port 60 that fits into the first connector 12) and the output portion (with port 58) and the output portion to restrict the output portion from being inserted through the second end of the first connector 12.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the second connector in the combination of Ira and Raines to include a protruding ring disposed between the coupling portion and the output portion to restrict the output portion from being inserted through the second end, as Fitzgibbons teaches (col. 3, lines 33-37), wherein the protruding ring also provides a clear limit stop and indication of the relative positions of the connectors for securing them together.
Regarding claim 23, Raines teaches in Figs. 1-3 (specifically the embodiment in Fig. 3) a third opening in the channel (comprising any of passages 66 or the end of channel 62 adjacent to passages 66) that fluidly connects the coupling portion 12 to the output portion 18 when the second valve 14 is in the compressed state (i.e. opened/unseated).
Regarding claim 24, Ira discloses in Figs. 1A-B and 10A-B that the mating portion (of the first connector 2) comprises a groove 68/69 proximate the second end and configured to secure the coupling portion (of the second connector 9) within the mating portion (col. 8, lines 58-67).
Regarding claim 26, Fitzgibbons teaches in Figs. 1-2 that the protruding ring 50 abuts an outer edge 52 of a channel on the first connector 12 when the first connector 12 is coupled to the second connector 14 (col. 3, lines 33-37).
Allowable Subject Matter
Claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to disclose or render obvious, in combination with the other limitations recited in claim 25, the mating portion of the first connector comprises a plurality of grooves corresponding to a plurality of positions at which the coupling portion of the second connector is configured to be secured within the mating portion.
Cotter (US 5,762,646) teaches in Figs. 1-11 a coupler comprising a male/second connector 11-2 with a plurality of grooves 11-8, 11-9 corresponding to a plurality of positions at which the female/first connector 11-1 is configured to be secured over the second connector 11-2, but lacks the female/first connector having said plurality of grooves for securing the male/second connector therein in a plurality of positions. Friedman (US 8,388,603), Thomas et al. (US 5,269,771), Fuchs (US 6,032,926) similarly teach connectors that are held at a plurality of positions by the utilization of a plurality of grooves on the male/second connector rather than the female/first connector.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Jonathan Waddy, whose telephone number is 571-270-3146. The examiner can normally be reached on Monday-Friday (10:00AM-6:00PM EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisors can be reached by phone. Kenneth Rinehart can be reached at 571-272-4881 or Craig Schneider can be reached at 571-272-3607. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J. W./
Examiner, Art Unit 3753