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 Group I (claims 1-13) in the reply filed on 2/13/2026 is acknowledged.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/13/2026.
Claim Objections
Claims 12-13 are objected to because of the following informalities:
-Claim 12, Line 2: “a” before “introducer” should be corrected to “an”.
-Claim 13, Line 2: “an” before “fluid” should be corrected to “a”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 1 and 6-13 are rejected under 35 U.S.C. 103 as being unpatentable over
US 2022/0257975 Al to Croll et al. (hereinafter 'Croll') in view of US 2003/0153865 Al to Connell et al. (hereinafter 'Connell').
Regarding claim 1, Croll discloses a multifunctional transfer set having enhanced capability to receive an elongate member insertably/retractably therethrough and allowing fluid to flow therethrough (see 148 with capability to receive an elongate fiber optic cable through line 150 and allowing fluid flow therethrough via tubing 156, Fig 12-13; 148 facilitates flow of fluids and the delivery of electromagnetic radiation (EMR) for radial emission, optical fiber 98 advanced through line 150 and 148 connected to PD catheter 166, para [0131]), the multifunctional transfer set comprising:
a transfer set body assembly having a transfer set body (see Fig 12) and a luer connector (see connector 152 with cap 162; port 152 with cap 162, para [0129]; see how 152 couples to a female luer adapter 118 as a coupling adapter; para [0127]; hence a coupling end of 152 is a luer connector, Fig 11, Fig 13), the transfer set body assembly having a passageway and a longitudinal axis each extending through the transfer set body and the luer connector (see a passageway connected within line 150 and longitudinal axis extending through for receiving an optical fiber as shown in Fig 13 when the cap 162 is removed; Fig 12, Fig 13; main line 150 between port 152 and 154, para [0129]; optical fiber 98 advanced into and through main line 150, para [0131]);
a Y-adapter with an access port (see Y-adapter with an access port of connected tubing 156 leading into main line 150; Fig 12), the Y-adapter being connected to the transfer set body assembly such that the longitudinal axis extends through a longitudinal portion of the Y-adapter and not through the access port (see how the Y-adapter is connected to the assembly such that the longitudinal axis extends through a longitudinal portion 150; Fig 12), the connected transfer set body assembly and longitudinal portion of the Y-adapter defines a longitudinal length for the multifunctional transfer set (see a longitudinal length of 150 and 152; Fig 12); and,
an extension sub-assembly connected to the access port (see branch tubing 156, clamp 160, and coupling port 158 connected to the access port into 150; Fig 12), the extension sub-assembly comprises branch tubing (see 156, Fig 12; branching line 156, para [0129]), a flow-control device (see 160, Fig 12, clamp 160 for selectively opening and closing 156, para [0129]), and a coupling assembly (see coupling port 158, Fig 12, side port 158, para [0129]) with a cap (see 162 on 158, Fig 12; sealing cap 162 for sealing 158, para [0129]), the extension sub-assembly allows fluid to flow therethrough into and out of the transfer set body assembly if the flow-control device is open and prevents fluid from flowing therethrough if the flow-control device is closed (clamp 160 for selectively opening and closing 156, para [0129]).
Croll teaches wherein different types of caps may be used for sealing ports/connectors of the device (differing types of sealing caps 162 for sealing ports 152, 154, 158, para [0129]), wherein the caps are used to protect the ports/connectors during transport or storage (para [0129]) but does not explicitly teach a ring cap.
Connell teaches a transfer set allowing fluid to flow therethrough for use with a dialysis catheter (see 10 with passage 26 and connected tube 40 to allow fluid to flow, Fig 1A, Fig 2-3; passage 26 that enables fluid such as dialysate to move from one end of 12 to another, para [0079]; tube 40 connects to a tube that runs to a dialysate container, para [0085]; 10 to attach to a transfer set, para [0096]) comprising a coupling assembly with a ring cap (see coupling assembly comprising threads 22 with a ring cap 42 to couple to 60, Fig 1A, Fig 2; tip protector 42 defines a ring 44, para [0087]; 10 threads onto a connector 60 using threads 22 which are exposed when 42 is removed, para [0098]) in order to provide a cap with a ring/handle allowing a user to easily remove the cap when ready to use the transfer set (para [0087]-[0088]).
It would have been obvious to a person having ordinary skill in the art to modify the cap of Croll such that it is a ring cap as taught by Connell in order to provide a cap with a ring/handle allowing a user to easily remove the cap when ready to use the transfer set.
Regarding claim 6, Croll teaches that the passageway insertably/retractably receives the elongate member therethrough (see how when coupled to 116, the passageway insertably/retractably receives the elongate member therethrough, Fig 13; see elongate member 98 within 116, Fig 9; elongate structure comprising optical fiber 98, para [0122]; barrel 116 with female luer coupling adapter 118, para [0127]; fiber optic 98 advanced through into and through main line 150 and into extension set 164, para [0131]).
Regarding claim 7, Croll teaches that the multifunctional transfer set facilitates the delivery of disinfecting/sterilizing light for preventing, reducing, and/or eliminating infectious agents within a dialysis system (see how 148 is used for delivery of disinfecting light within a dialysis system including catheter 166 and extension set 164, Fig 13, Fig 17-18; embodiment of peritoneal dialysis system 206, para [0153]; optical fiber to deliver and emit radially sterilizing EMR into extension set 164 and 208, para [0131], para [0153]) comprising an extension line (see extension line 208, Fig 18; fluid extension line 208, para [0153]), dialysate bags (see how dialysate bags 212 and 214 are coupled to 208 via dialysate exchange switch 210, Fig 17-18; fluid extension line 208, dialysate exchange switch 210, supply bag 212, waste retrieval bag 214, para [0147], para [0153]), and a dialysis catheter (see 166, Fig 18, PD catheter 166 for peritoneal dialysis, para [0148], para [0131]), wherein the extension line is connectable to and intermediate of the dialysate bags and the luer connector (see how 208 is connectable to and intermediate of 212, 214 and the luer connector of 148, Fig 13, Fig 17-18) and the dialysis catheter is connectable to the coupling assembly of the extension sub-assembly (see how 166 is connectable to the coupling assembly 158, Fig 13, Fig 18), such that dialysate flowing between the dialysate bags and the dialysis catheter passes through the extension line, at least a portion of the longitudinal portion of the Y-adapter, the access port, the branch tubing, and the dialysis catheter (see how dialysate flowing from the bag flows through switch 210, line 208, line 164, at least a portion of the longitudinal portion of the Y-adapter of 148, the side access port of 148, the branch tubing 156, and the catheter 166, Fig 13, Fig 17-18, dialysate within 148 and 164, para [013l]; para [0147], para [0153]);
wherein the elongate member comprises a connector assembly (see how the elongate member comprises a connector assembly 96 including 116, Fig 9, Fig 12; barrel 116 with luer adapter 118 that serves as a coupling adapter, para [0127]; optical fiber 98 is advanced into barrel 116, para [0131]) and a fiber optic (see fiber optic 98, Fig 9, optical fiber 98, para [0131]), the connector assembly is connectable to the longitudinal portion of the Y-adapter such that the fiber optic extends into the longitudinal portion of the Y-adapter (see how 116 is connectable to the longitudinal portion of the Y-adapter such that the fiber optic extends into the longitudinal portion, Fig 12, para [0131]), the fiber optic for receiving disinfecting/ sterilizing light and delivering disinfecting/sterilizing light to prevent, reduce, and/or eliminate infectious agents (for delivery of sterilizing EMR to prevent infection agents from populating, para [0131]).
Regarding claim 8, Croll teaches that the fiber optic has a length that extends into the extension line and is disposed to deliver disinfecting/sterilizing light by emission within the extension line (see how with 96 connected to 148, 98 extends into 208, Fig 18; 98 is advanced through 148 and into the extension set 164 for delivery of EMR for radial emission, para [131]; EMR light at a treatment location within the fluid extension line 208, para [0153]).
Regarding claim 9, Croll teaches that the flow control device is a pinch clamp disposed on the branch tubing (see pinch clamp 160 disposed on the branch tubing 156, Fig 12-13; clamp 160 for selectively closing branching line 156, para [0129]).
Regarding claim 10, Croll and Connell teach the multifunctional transfer set of claim 1, but do not explicitly teach that the multifunctional transfer set is packaged within a pre-packaged kit along with the elongate member, contents of the prepackaged kit being sterilized and compatibly matched in size and structure to operate together with the elongate member to accomplish a designed purpose, the elongate member being selected from the group of elongate members consisting of a guide wire, an endoscope, an angioscope, a hysteroscope, a gastroscope, a flexible telescope for colonoscopies, bronchoscope, a cystoscope, probes for illumination, probes for pinpoint medication or treatment delivery, probes for
inflation gas delivery, and fiber optics, wherein dimensions of the multifunctional transfer set compatibly match the elongate member selected such that a maximum diameter of the elongate member is less than a minimum diameter of the multifunctional transfer set.
Croll teaches that the multifunctional transfer set may be part of a kit along with the elongate member (see how 148 is part of a kit comprising dialysis system 206 and light engine system 10 which includes the elongate member 98, Fig 17-18; the peritoneal dialysis system 206 has been enhanced by adding light engine system 10 and this may be part of a kit that includes 206 and 10, para [0149], para [0153]), wherein the elongate member is pre-packaged within a pre-packaged kit (see packaging 106 of the elongate member 98, Fig 10; packaging 106 for the fiber optic disposable 96, para [0124]) in order to maintain the sterility of the elongate member during transport and storage (para [0124]), contents of the prepackaged
kit being sterilized (packaging 106 to maintain the sterility of the fiber optic disposable during transport and storage, para [0124]), contents of the kit compatibly matched in size and structure to operate together with the elongate member to accomplish a designed purpose (see how the contents are matched in size and structure to operate with 98 to accomplish a purpose of delivering sterilizing light, Fig 18, para [0153]), the elongate member consisting of fiber optics (optical fiber 98, para [0153]), wherein dimensions of the multifunctional transfer set compatibly match the elongate member selected such that a maximum diameter of the elongate member is less than a minimum diameter of the multifunctional transfer set (see how a diameter of 98 is less than a minimum diameter of 148 such that it can be advanced into and through 148, Fig 18, para [0131], para [0153]), however Croll does not explicitly teach wherein the multifunctional transfer set is also packaged within the pre-packaged kit along with the elongate member.
However, it would have been obvious to a person having ordinary skill in the art to modify the kit of Croll in view of Connell such that the multifunctional transfer set is also packaged within the pre-packaged kit along with the elongate member in order to provide a protective packaging to maintain the sterility of the entire kit during transport and storage.
Regarding claim 11, Croll teaches that the elongate member is a fiber optic (optical fiber 98, para [0153]).
Regarding claim 12, Croll teaches that the contents of the pre-packaged kit further comprises a introducer assembly (see introducer assembly comprising 100 and 116, Fig 9-10; optical fiber 98 enclosed within sleeve 100, para [0122]; sleeve 100 secured against barrel 116, para [0127]), the introducer assembly disposed in a ready mode (100 is collapsed to nest within barrel 116 placing it into its collapsed mode, para [0127]) and having a length to receive and hold the fiber optic in position for introduction into the multifunctional transfer set (optical fiber 98 enclosed within sleeve 100 which may have various overall lengths to accommodate the desired length of 98, para [0122]; 148 is connected to the fully collapsed fiber optic disposable (i.e. in its collapsed mode) with 98 advanced through 148, para [0131]).
Regarding claim 13, Croll teaches that the contents of the pre-packaged kit further comprises a fluid extension line for connection to the multifunctional transfer set (see how the kit further comprises a fluid extension line 164 and 208 for connection to 148, Fig 18; kit includes peritoneal dialysis system 206, para [0149]; 206 includes fluid extension line 208, para [0153]), the fiber optic having a length to extend through the multifunctional transfer set and into the fluid extension line (see how 98 has a length to extend through 148 and into 208, Fig 18, para [0153]).
Allowable Subject Matter
Claims 2-5 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
3/4/26