DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 10/06/2025. As directed by the amendment: Claims 1-53 were previously cancelled. Claims 54 has been amended.
Thus, claims 54-74 are still pending in this application.
Applicant’s amendments to the drawings and specification have overcome each and every objection previously set forth in the Non-final Office Action mailed on 05/06/2025.
Applicant’s amendments to the claims have overcome each and every 112(b) claim rejection previously set forth in the Non-final Office Action mailed on 05/06/2025.
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.
Claims 54-67 are rejected under 35 U.S.C. 103 as being unpatentable over Mangelberger et al (US 20140212833 A1) in view of Colman (US 20150265828 A1) and further in view of Pananen et al (US 20160015885 A1).
Regarding claim 54, Mangelberger et al disclose a connecting piece (see fig 1) for fluidic coupling of medical appliances and/or medical lines (para 0010 and 0015), comprising: a connector (5), wherein the connecting piece: is designed for coupling to a correspondingly designed counter-connecting piece (4, see fig 2 and para 0038); has a fluid channel (31 and lumen of 5) surrounded by a conduction section (para 0012-sleeves made of material metals which are excellent conductors, see fig 2) for circumferentially tight coupling in a plug-in direction to the counter-connecting piece and for subsequent exchange of liquids and/or gases with the counter-connecting piece (para 0010, 0037-38 and 0040); and has a transmission device (12) for data transmission and/or for transmission of electrical energy with the counter-connecting piece (para 0016 and 0039-41); wherein the transmission device (12) has at least one coil (coil 18, para 0019 and see fig 3).
Mangelberger et al fail to disclose said connecting piece is in the form of one of: a connector of the ISO 80369 family of standards, or a plug for an infusion bottle according to ISO 8536-2 comprising a crimp cap for an infusion bottle according to ISO 8536-3 or comprising a piercing spike according to ISO 8536-4 for connection to an infusion bottle or a bag, or a subcutaneous implanted port according to ISO 10555-6, or a non-coring cannula for coupling to an implanted port according to ISO 10555-6, or a conical connector for anesthetic and respiratory equipment according to ISO 5356-1, or a connector according to ISO 5367, or a connecting piece for surgical wound drainage systems according to ISO 20697, or a connecting piece of an extracorporeal circuit of a hemodialysis system, hemodiafiltration system or hemofilter system as a blood port according to ISO 8637-1, or a connecting piece for connection to blood ports for dialysis systems according to ISO 8637-2, or a connecting piece for internal connection of a dialysis system as a port for dialysis liquid according to ISO 8637-1.
However, Colman discloses a connecting piece (see fig 1A-B, connector 15) comprising a connector of the ISO 80369 family of standards (para 0004 and 0092).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mangelberger et al and incorporate the teachings of Colman to have said connecting piece comprising a connector of the ISO 80369 family of standards. This would provide the benefit of having a medical connector that ensures the safety and reliability of small-bore connectors used in medical devices for delivering liquids and gases in healthcare applications (para 0037 and 0047).
Mangelberger et al fail to teach said coil is at least one planar or helical coil surrounds the fluid channel.
Pananen et al disclose a connector (30, fig 8) comprising a transmission device (para 0106, RF detection) comprising a helical coil (93, note a coil is inherently a helical shape) surrounds the fluid channel (32, fig 8).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coil of Mangelberger et al to surround the fluid channel as taught by Pananen et al. This would provide the benefit of having a ring-shaped transmitter coils for wireless power transfer that offer uniform magnetic fields, which helps minimize resistive losses and this allows an ease of manufacturing such as the coil can be made separately from said connector and then assembled with the connector during or after manufacture of the connector to provide aesthetic advantages over bulkier, less visually appealing coil designs (see para 0534).
Regarding claim 55, Mangelberger et al in view of Colman and Pananen et al disclose the connecting piece as claimed in claim 54,
Pananen et al further teach wherein: the at least one planar or helical coil comprises at least one planar coil, and the at least one planar coil is spiral shaped (see figs 9-11); or the at least one planar or helical coil comprises at least one helical coil (fig 8, coil 93), and the at least one helical coil is cylindrical or conical (fig 8, coil 93 is cylindrical).
Regarding claim 56, Mangelberger et al in view of Colman and Pananen et al disclose the connecting piece as claimed in claim 54,
Pananen et al further teach wherein: the at least one planar or helical coil comprises at least one planar coil (see figs 9-11), the connecting piece has a circumferential collar (94), and the at least one planar coil is provided on or in the circumferential collar (see fig 8).
Regarding claim 57, Mangelberger et al in view of Colman and Pananen et al disclose the connecting piece as claimed in claim 54,
Pananen et al further teach wherein: the at least one planar or helical coil comprises at least one helical coil (coil 93), the connecting piece has a sleeve-shaped ring section (94), on the inner side of which, on the outer side of which or within which the at least one helical coil is provided (see fig 8).
Regarding claim 58, Mangelberger et al in view of Colman and Pananen et al disclose the connecting piece as claimed in claim 54,
Mangelberger et al further teach wherein the connecting piece: is made from plastic at least in part, and/or has at least one metallic or polymeric conductor for conducting electrical energy or for conducting data (para 0012).
Regarding claim 59, Mangelberger et al in view of Colman and Pananen et al disclose the connecting piece as claimed in claim 54,
Mangelberger et al further teach the connecting piece including: at least one output device (para 0042- Light Emitting Diode on board 22 on connector 5).
Regarding claim 60, Mangelberger et al in view of Colman and Pananen et al disclose the connecting piece as claimed in claim 54,
Mangelberger et al further teach the connecting piece including: an integrated circuit (22) which is supplied with power by the transmission device for transmission of electrical energy and/or which is connected to the transmission device for data transmission (para 0042).
Regarding claim 61, Mangelberger et al in view of Colman and Pananen et al disclose the connecting piece as claimed in claim 54,
Mangelberger et al further teach the connecting piece including: a sensor for capturing a property of a fluid flowing through or for capturing a volumetric flow rate of the fluid flowing through, or for capturing a coupling state of the connecting piece on the counter-connecting piece (para 0048).
Regarding claim 62, Mangelberger et al in view of Colman and Pananen et al disclose a set of at least two connecting pieces (see figs 1-2), wherein: each of the two connecting pieces comprises the connecting piece as claimed in claim 54
Mangelberger et al further teach the connecting pieces are for mechanical coupling to one another (fig 2); the two connecting pieces being designed in such a way that, through mechanical coupling, respective fluid channels thereof are brought into communicating and circumferentially- tight connection with one another (para 0010); and the two connecting pieces being designed in such a way that, through mechanical coupling, respective transmission devices thereof are brought into a position relative to one another that allows data transmission or transmission of electrical energy (see figures and para 0014-16 and 0026).
Regarding claim 63, Mangelberger et al in view of Colman and Pananen et al disclose a medical fluid line for transferring liquids and/or gases (see figures and para 0015), comprising: a conduction body (protrusion 7, para 0012-material made of metal) comprising a rigid pipe body (metal body) or a flexible tube body that surrounds a fluid channel (see figs 1-2); and the connecting piece as claimed in Claim 54 at a proximal end of the conduction body (see fig 1, protrusion 7 is at proximal end of connector 5).
Regarding claim 64, Mangelberger et al in view of Colman and Pananen et al disclose the medical fluid line as claimed in claim 63,
Mangelberger et al further teach the connecting piece further including: a second connecting piece (connector 4) at a distal end of the fluid line (see figures); and/or an electrically conductive conductor for conducting digital data and/or for conducting electrical energy along the conduction body; and/or a wall of the conduction body within which the conductor is arranged (transfer unit 12, see figures 1 and 2, para 0012).
Regarding claim 65, Mangelberger et al in view of Colman and Pananen et al disclose a fluid-guiding medical appliance (abstract, para 0010 and 0037),
Mangelberger et al further teach wherein: the appliance is designed for receiving, conducting and/or delivering fluids (para 0037-38); the appliance is designed for receiving, conducting and/or delivering data and/or electrical energy (para 0014-16); and the appliance has the connecting piece as claimed in Claim 54 for combined receiving, conduction and/or delivery of data and/or electrical energy and of a fluid (see figures and para 0037-39).
Regarding claim 66, Mangelberger et al in view of Colman and Pananen et al disclose the fluid-guiding medical appliance as claimed in claim 65,
Mangelberger et al further teach the medical appliance further including: at least one actuator for controlling the fluid and/or applying pressure thereto; and/or at least one sensor for capturing a property of the fluid or for capturing a volumetric flow rate of the fluid; and/or at least one integrated circuit which is supplied with power by the transmission device for transmission of electrical energy and/or is connected to the transmission device (12) for data transmission (para 0042 and 0048).
Regarding claim 67, Mangelberger et al in view of Colman and Pananen et al disclose the fluid-guiding medical appliance as claimed in Claim 66,
Mangelberger et al further teach wherein: the appliance is designed as a conveying unit (see figures and abstract, the system is designed to receive data, to evaluate said data and to respond accordingly to said data).
Claims 68 and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Mangelberger et al (US 20140212833 A1) in view of Colman (US 20150265828 A1) and Pananen et al (US 20160015885 A1) and further in view of Hyde et al (US 20160114104 A1).
Regarding claim 68, Mangelberger et al in view of Colman and Pananen et al disclose the limitations of claims 54, 65-66 as discussed above but fail to teach said fluid-guiding medical appliance, wherein: the appliance is designed as a central venous catheter or as a peripheral venous catheter.
Mangelberger et al disclose a coupling device for detachably connecting a medical instrument (see abstract).
However, Hyde et al disclose coupling elements designed as a venous catheter (see fig 2 and 0037).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mangelberger et al in view of Colman and Pananen et al and incorporate the teachings of Hyde et al to have said system designed as a central venous catheter or as a peripheral venous catheter. This would provide the benefit of using said device for venous infusion which has a data transmitter that communicates via an optical signaling apparatus and smart connectors, a medicament source connector and a patient recipient connector to verify the patient's identity, the prescribed medication/medicament, and the status of drug delivery (para 0061).
Regarding claim 74, Mangelberger et al in view of Colman and Pananen et al disclose the limitations of claims 54 but fail to teach a medical fluid conduction and transfer system comprising: an access unit for a patient for administrating a fluid or a fluid mixture into the patient and/or for withdrawing a fluid from the patient; and at least one liquid container for providing or accommodating the fluid; wherein the access unit and/or the liquid container has the connecting piece.
Mangelberger et al disclose a coupling device for detachably connecting a medical instrument (see abstract).
However, Hyde et al disclose a medical fluid conduction and transfer system (see fig 1A) comprising: an access unit for a patient for administrating a fluid or a fluid mixture into the patient and/or for withdrawing a fluid from the patient (catheter 147, para 0031); and at least one liquid container (source reservoir 190) for providing or accommodating the fluid (para 0031); wherein the access unit and/or the liquid container has an connecting piece (see fig 1A).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mangelberger et al in view of Colman and Pananen et al and incorporate the teachings of Hyde et al to have an access unit for a patient for administrating a fluid or a fluid mixture into the patient and/or for withdrawing a fluid from the patient; and at least one liquid container for providing or accommodating the fluid; wherein the access unit and/or the liquid container has the connecting piece. This would allow data transmission from the medicament source connector to the patient recipient connector (para 0006).
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Mangelberger et al (US 20140212833 A1) in view of Colman (US 20150265828 A1) and Pananen et al (US 20160015885 A1) and further in view of Nelson (US 20160279404 A1).
Regarding claim 69, Mangelberger et al in view of Colman and Pananen et al disclose the limitations of claims 54, 65-66 but fail to teach said fluid-guiding medical appliance, wherein: the appliance is designed as a valve bank or a multi-way valve.
However, Nelson discloses a fluid-guiding medical appliance designed as a valve bank or a multi-way valve (fig 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mangelberger et al in view of Colman and Pananen et al and incorporate the teachings of Nelson to have said connectors designed as a valve bank or a multi-way valve. This would provide the benefit of having multiway valve medical connectors on one end of a flow line to allow for periodic access to a flow line or for application of different inputs to the flow line. Generally, these structures require valves to allow fluid to enter the main flow line while preventing retrograde flow (para 0006).
Claims 70 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Mangelberger et al (US 20140212833 A1) in view of Colman (US 20150265828 A1) and Pananen et al (US 20160015885 A1) and further in view of Labib et al (US 20160375188 A1).
Regarding claim 70, Mangelberger et al in view of Colman and Pananen et al disclose the limitations of claims 54, 65-66 but fail to teach said fluid-guiding medical appliance, wherein: the appliance is designed as a hemodialysis cartridge, a hemodiafilter cartridge, a hemofilter or a hemoconcentrator cartridge.
However, Labib et al disclose a fluid-guiding medical appliance designed as a hemodialysis cartridge, a hemodiafilter cartridge, a hemofilter or a hemoconcentrator cartridge (para 0095-96, figs 1-3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mangelberger et al in view of Colman and Pananen et al and incorporate the teachings of Labib et al to have said appliance designed as a hemodialysis cartridge, a hemodiafilter cartridge, a hemofilter or a hemoconcentrator cartridge to perform hemodialysis and related extracorporeal blood treatment modalities and therapies, in which blood flows in the inter fiber space and dialysate flows in the lumens of hollow fibers (see abstract).
Regarding claim 72, Mangelberger et al in view of Colman and Pananen et al disclose the limitations of claims 54, 65-66 but fail to teach said fluid-guiding medical appliance as claimed in Claim 66, wherein: the appliance is designed as a filter appliance.
However, Labib et al disclose a fluid-guiding medical appliance designed as a filter appliance (para 0008).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mangelberger et al in view of Colman and Pananen et al and incorporate the teachings of Labib et al to have said appliance designed as a filter appliance. This makes the treatment modality safer as it provides a single use solution filter that does not add additional cost or the need for disposables (para 0008).
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Mangelberger et al (US 20140212833 A1) in view of Colman (US 20150265828 A1) and Pananen et al (US 20160015885 A1) and further in view of Hilaire (US 7335182 B1).
Regarding claim 71, Mangelberger et al in view of Colman and Pananen et al disclose the limitations of claims 54, 65-66 but fail to teach said fluid-guiding medical appliance, wherein: the appliance is designed as an auxiliary port device and has a fluid line provided with a connecting piece on both sides, between which there is provided an auxiliary port for ad hoc addition of a fluid.
However, Hilaire discloses a fluid-guiding medical appliance (see fig 5) wherein: the appliance is designed as an auxiliary port device and has a fluid line (attachment 310) provided with a connecting piece on both sides, between which there is provided an auxiliary port for ad hoc addition of a fluid (see fig 5, col 5, lines 65-67).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mangelberger et al in view of Colman and Pananen et al and incorporate the teachings of Hilaire to have said appliance designed as an auxiliary port device and has a fluid line provided with a connecting piece on both sides, between which there is provided an auxiliary port for ad hoc addition of a fluid. This would provide the benefit of attaching to another device, such as a syringe or a connector tube for addition of a fluid (col 5, lines 65-67).
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over Mangelberger et al (US 20140212833 A1) in view of Colman (US 20150265828 A1) and Pananen et al (US 20160015885 A1) and further in view of Weiss et al (US 20160073929 A1).
Regarding claim 73, Mangelberger et al in view of Colman and Pananen et al disclose the limitations of claims 54, 65-66 but fail to teach said fluid-guiding medical appliance, wherein: the appliance is designed as a ventilation tube.
However, Weiss et al disclose a fluid-guiding medical appliance designed as a ventilation tube (para 0016).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Mangelberger et al in view of Colman and Pananen et al and incorporate the teachings of Weiss et al to have said appliance designed as a ventilation tube. This would provide the benefit of having a device operable to analyze gas (para 0021).
Response to Arguments
Applicant’s arguments with respect to claim(s) 54-74 have been considered but they are not persuasive.
With the regards to the arguments that the Mangelberger et al. '833 publication is drawn to a coupling device that includes an instrument 2 that is specifically configured to be non-rotatably connected to a drive unit 3. The drive unit 3 includes a coupling element 5 in the form of a protrusion 7 that is configured to be inserted into a coupling recess 6 of the instrument 2. The coupling protrusion 7 and the coupling recess 6 are not disclosed as performing any function other than the protrusion 7 being received into the recess 6.
Examiner respectfully disagrees as connector 5 and recess 6 are free to rotate until position element 8 and indentation 9 are coupled (para 0010), thus said fluid channel is rotatable until the connecting piece and counter connecting piece are coupled .
With regards to the arguments, the Mangelberger et al. '833 publication does not disclose any fluid passing through the coupling protrusion 7. The Mangelberger et al. '833 publication only discloses fluid potentially passing through the media line 31. No conduction section of the Mangelberger et al. '833 publication surrounds the media line 31.
Applicant is reminded that even if fluid passes through the media line 31, it will also pass the protrusion 7 since the connecting piece 5 is hollow and connector sleeve is made of metal, thus it surrounds the fluid channel.
With regards to the arguments that the Office Action in a first step combines the Colman '828 publication with the Mangelberger et al. '833 publication to result in the form of the connecting piece as claimed. The Colman '828 publication discloses a Luer connection system including a female Luer connector 11 and a male Luer connector 15. As set forth in the background of the Colman '828 publication, a Luer connection system is "a standardized system of small-scale fluid fittings and the connector of the Mangelberger et al. '833 publication as the coupling element 5. The coupling element 5 of the Mangelberger et al. '833 publication does not have any liquid or gas passing therethrough."
Examiner respectfully disagrees as Mangelberger et al disclose in para 0010 is an outer sleeve and a second coupling element of a coupling device for supplying the instrument with media, in particular with water, compressed air or light. Thus it is obvious to make said connecting piece comprises an ISO 80369 family of standards to ensure the safety and reliability of small-bore connectors used in medical devices for delivering liquids and gases in healthcare applications as taught by Colman.
Conclusion
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.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /DUNG T ULSH/Examiner, Art Unit 3783