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 .
Election/Restrictions
Applicant’s election without traverse of Species II (claims 15-19, Figs. 6-8) in the reply filed on 26 February 2026 is acknowledged.
Claims 1-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species I (claims 1-14, Figs. 2-5), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 February 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
---At least Para. [0053] mentions reference number “214” and “218”. Notice that reference numbers “214” and “218” are not shown in the drawings. It is also noted that Figs. 6-8 shows instead references numbers “114” and “118” which appears to correlate to those used in Para. [0053] for “214” and “218” and notice that most of the reference numbers used for the second/elected embodiment of Figs. 6-8 uses the reference number series “2XX” (e.g. 200, 210, 250, etc.) which leads to the conclusion that a typo occurred in Figs. 6-8 and reference numbers “114” and “118” in Figs. 6-8 should be amended to “214” and “218” to be consistent with the specification.
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. 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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Phillips US-10315025 in view of Coambs US-20080197626 and Shi CN-107126621.
Regarding claims 15-19, Phillips US-10315025 teaches in Figs. 1-9 (see at least Figs. 4-5 and 8-9) of an auto-shutoff breakaway coupling 100 for supplying medical fluids to a patient. The coupling assembly 100 comprises at least a female coupling 200 with a compliant material check valve 502 and a male coupling 202 comprising a protrusion 210 and a compliant material check valve 500 and a break-away locking means (206 and 204) that allows the couplers to couple and selectively “break-away” once a predetermined pulling force is reached. When the couplers are coupled, the protrusion 210 of the male coupling displaces the check valve 502 of the female coupling and fluid pressure opens the check valve 500 of the male coupling, thus creating a continuous fluid pathway between the upstream end of the female coupling and the downstream end of the male coupling. When the couplings are uncoupled, such as in the case where the patient inadvertently and forcibly pulls the connection, the couplers break-away and the valves automatically closes, thus achieving a dry-disconnect while preventing harm to the patient in a similar manner as applicant’s general invention. Notice that Phillips fails to disclose the use of magnets as the break-away coupling between the two adapters as claimed. However, magnetic breakaway couplings are known in the art.
Coambs US-20080197626 teaches in Figs. 1-14 and at least Para. [0073] of yet another example of a medical valved coupling assembly 8 comprising at least a female coupler 10 and a male coupler 12 with a breakaway safety feature via the use of a snap-fit connection between protrusions 16 of the female coupler and groove 30 of the male coupler (notice that this is similar to the break-away feature as taught by Phillips). Para. [0073] of Coambs teaches that while the break-away feature shown in at least Fig. 1 of Coambs is a snap-fit breakaway connection, other alternative break-away arrangements are possible such as using a magnetic coupling.
It would have been obvious to one of ordinary skill in the art at the time that the invention was effectively filed to modify the break-away coupling of the device of Phillips to be a magnetic break-away coupling in a similar manner as taught by Coambs since such an arrangement is a known alternative method of providing a quick, easy and secure fluid coupling that provides a break-away safety feature once a predetermined amount of separating force is achieved. Notice that while the device of the combination of Phillips in view of Coambs teaches of a magnetic breakaway coupling, the device of the combination fails to disclose the particular structure of magnetic coupling such as being magnetic rings as claimed. However, magnetic rings couplings are well known in the art.
Shi CN-107126621 teaches in Figs. 1-12 (see at least Figs. 1-3B) of a medical tube coupling comprising pipelines 1 surrounded by a magnetic ring 2 and shell 3 that allows the pipelines 1 to be easily coupled using the magnetic attraction of the magnetic rings 2 while providing magnetic shielding to the outside.
It would have been obvious to one of ordinary skill in the art at the time that the invention was effectively filed to modify the magnetic coupling of the device of the combination of Phillips in view of Coambs to be a magnetic coupling similar to the one as taught by Shi which includes magnetic rings 2 and shell 3 surrounding the pipelines since such a modification allows the couplers to be quick and easily coupled using magnetic rings while providing magnetic shielding to the outside as taught by Shi while maintaining the magnetic break-away feature as taught by Coambs.
As such, the device of the combination of Phillips US-10315025 in view of Coambs US-20080197626 and Shi CN-107126621 teaches the limitations of:
---Claim 15. A coupling (100 of Phillips as modified by Coambs and Shi to include magnetic rings acting as the breakaway coupling) comprising: a first assembly (200 of Phillips as modified by Coambs and Shi to include at least magnet ring 2 of Shi acting as the magnetic breakaway coupling as taught by Coambs) comprising: an inlet port (the upstream port of 200 of Phillips that is fluidly connected to feeding source 102); a first valve chamber (the interior of 200 of Phillips) housing a first one-way valve (502 of Phillips) formed of a compliant material (see at least Figs. 4-5 and 8-9 of Phillips); and a first magnetic ring (see magnetic ring 2 of Shi which can act as a magnetic break-away coupling as taught by Coambs) circumferentially disposed about the first assembly; a second assembly (202 of Phillips as modified by Coambs and Shi to include at least magnet ring 2 of Shi acting as the magnetic breakaway coupling as taught by Coambs) comprising: an outlet port (see the downstream port of 202 of Phillips that is fluidly connected to patient 106); a second valve chamber (the interior of 202 of Phillips) housing a second one-way valve (500 of Phillips); a protrusion (210 of Phillips) extending from the second assembly toward the first assembly; and a second magnetic ring (see the other magnetic ring 2 of Shi which can act as a magnetic break-away coupling as taught by Coambs) circumferentially disposed about the second assembly; wherein, the coupling moves between a connected state, where the two assemblies are magnetically joined together (see at least Fig. 3A of Shi and Fig. 9 of Phillips), and a disconnected state (Fig. 5 of Phillips); wherein, when the coupling is in its connected state, the protrusion mechanically engages with and displaces the first one-way valve creating a continuous fluid pathway between the inlet port and the outlet port (see Fig. 9 of Phillips); and wherein, when the coupling is in its disconnected state, the first one-way valve automatically returns to a sealed position preventing fluid discharge (see Fig. 5 of Phillips).
---Claim 16. The coupling of claim 15, wherein the first and second magnetic rings are oriented with opposite polarities to create an attractive force when the assemblies are brought into proximity (it is noted that while the device of the combination fails to explicitly disclose this limitation, this limitation is inherently met by the teachings of at least Shi and Coambs with both teaching of the use of magnetic attraction for coupling the fluid lines. In order for magnetic attraction to occur, the magnets require to have opposite polarities, N – S, otherwise if the polarities are the same, N – N or S – S, magnetic repulsion would occur which would hinder the fluidic coupling. As such, one of ordinary skill in the art can recognize that in order to provide the magnetic attraction for the magnets 2 to effectively couple the fluid lines 200 and 202, the magnetic rings 2 must be oriented with opposite polarities to create the attractive force when the assemblies are brought into proximity, otherwise the magnets would repulse each other and hinder the operation of the device).
---Claim 17. The coupling of claim 15, wherein the first valve chamber and second valve chamber are generally cylindrical in shape with diameters sufficient to accommodate their respective valves (see at least Figs. 4-5 and 8-9 of Phillips).
---Claim 18. The coupling of claim 15, wherein the first one-way valve is oriented to permit fluid flow toward the second assembly while preventing backflow toward the inlet port, and the second one-way valve is oriented to prevent backflow from the outlet port (see at least Figs. 4-5 and 8-9 of Phillips).
---Claims 19. The coupling of claim 15, wherein the magnetic rings separate when a predetermined tensile force is applied to prevent patient harm (Phillips teaches of a break-away coupling that aids in preventing harm to patient 106, Shi teaches of a magnetic coupling comprising magnetic rings 2 and at least Para. [0073] of Coambs teaches of using magnets as an alternative method of providing the break-away coupling feature).
Conclusion
The relevant/prior art made of record and considered pertinent to applicant's disclosure is as follows:
---References A (Enteral feeding systems relevant to applicant’s field of invention): Piper US-12017039 (not considered “prior art” under US laws) and Harr US-9852263.
---References B (valved couplings relevant to applicant’s overall disclosure): Jones US-12465742, Axelsson US-12442476, Bejhed US-12239813, Kumar US-12023462, Jones US-10864362, Rogier US-9717897, Whitley US-7645274, Huet US-6595981, Erskine US-5820614, Guala US-20190134378, Clawson US-20080128646 and Kust US-20030070273.
---References C (Magnetic couplings similar to a feature of the claimed invention): Breedon US-12472341, Lust US-12474002, Roundy US-12214154, Clever US-11603954, Zoe US-11549625, Chanclon US-10800102, Scott US-9803787, Cornett US-9604838, Wolff US-9322498, Davis US-9279527, Wolff US-9140393, Doherty US-8770190, Zimmermann US-7891637, Imler US-7252112, Arnold US-3586048, Sullivan US-20250177720, Horikawa US-20240159358, Parvaneh US-20230084777, Haubert US-20220040450, Ashida US-20200116284, Bernshtein US-20120011701, Paden US-20110084474, House US-20080208170, Coambs US-20080197626, Coambs US-20070066965, Frere EP-2781818, Feng CN-116906707 and Shi CN-107126621.
---References D (Check valved couplings similar to applicant’s main invention): Jadhav US-12403295, Dikeman US-11690993, Jones US-10655768, Bonnal US-10625071, Phillips US-10315025, Williams US-8974437, Diodati US-8899267, Grimm US-8758307, Fournie US-7955317, DiFiore US-7347853, Utterberg US-7025744, Fujuu US-6851448, Wesseler US-5534228, Somor US-4838875, Abramson US-4143853, Winnard US-3601151 and Dikeman US-20230022342.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID COLON-MORALES, whose telephone number 571-270-1741 and fax number is 571-270-2741. If the applicant has authorized internet communications via the filling of form PTO/SB/439, the examiner can be reached via email at david.colon-morales@uspto.gov , email communication is not permitted if the applicant has not filed an authorization for internet communication (see MPEP 502.03 for more details on internet communications). The examiner can normally be reached on Monday-Friday (7:30AM-3:30PM EST).
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/DAVID COLON-MORALES/Primary Examiner, Art Unit 3753