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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/6/2026 has been entered.
Response to Amendment
The amendment filed on 7/6/2026 has been entered. Claims 1-6, 10-11, 13-16, and 18-20 are pending in the application. Claims 7-9, 12, and 17 are cancelled.
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 1, 10-11, 13, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nordquist et al. (US 2016/0067148 A1) in view of Breitweiser (US 2020/0282135 A1) and further in view of Koelper et al. (US 2016/0143815 A1).
Regarding claim 1, Nordquist discloses a bolus feed delivery system for enteral feeding (see Fig. 2A, par. [0046]) comprising:
a reusable nutrition container (feeding container 246) including a volume configured to hold a source of nutrition (see par. [0046]-[0047]) and enable gravity feeding (see par. [0046], [0036], fluid from feeding container 246 can be delivered via pump 248 or simply gravity);
a first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047]);
an inline access port (Y-connector 220) attached to the first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047]);
a second tube (fluid delivery tubing 244) coupled to the inline access port (Y-connector 220) (see Fig. 2A, par. [0046]-[0047]);
a feeding tube adapter (proximal portion of connector apparatus 235) coupled to the second tube (fluid delivery tubing 244) and including a stem sized to be received in a receiving port (distal portion of connector apparatus 235) of an indwelling feeding tube (feeding tube 238) (see Fig. 2A and par. [0046]-[0047] which state that fluid delivery tubing 244 connects to feeding tube 238 via a standard enteral feeding connector apparatus 235 which appears to show a proximal “stem” portion inserted into a distal “receiving port” having a tethered cap; see further Fig. 1 and par. [0038] and [0045] which shows the standard enteral feeding connector apparatus as element 135 in Fig. 1 having two triangular portions with a proximal “stem” received in a distal “receiving port”);
a first clamp (roller clamp or other clamping mechanism 231) comprising a first clamp aperture sized to receive the first tube (administration tubing 242) and configured to restrict flow of fluid through the first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047], roller clamp or other clamping mechanism 231 is positioned over the administration tubing 242 such that it has an opening for receiving the administration tubing 242); and
a second clamp (clamping mechanism 139) comprising a second clamp aperture sized to receive the second tube (fluid delivery tubing 244) and configured to restrict flow of fluid through the second tube (fluid delivery tubing 244) (see Fig. 2A, par. [0038], [0054]-[0055], clamping mechanism 139 is positioned over the fluid delivery tubing 244 such that it has an opening for receiving the fluid delivery tubing 244).
However, Nordquist fails to expressly state how the reusable nutrition container connects to the first tube. Specifically, Nordquist fails to state the reusable nutrition container including a rigid container connector defining external threads; a nutrition adapter including a collar including internal threads sized to directly engage the external threads of the rigid container connector to enable gravity feeding; the first tube coupled to the nutrition adapter. Further, Nordquist fails to expressly state wherein the nutrition adapter, the first tube, the inline access port, the second tube, and the feeding tube adapter are permanently coupled together.
Breitweiser teaches a bolus feed delivery system (see Figs. 1 and 7-9, par. [0036]) comprising: a reusable nutrition container (syringe 14) including a rigid container connector (female tip 24) defining external threads (external thread 26) (see Figs. 1 and 7-8, par. [0039], [0041]-[0042], [0045]-[0046]); a nutrition adapter (syringe connector 30) including a collar (outer skirt 44) including internal threads (internal thread 46) sized to directly engage the external threads (external thread 26) of the rigid container connector (female tip 24) (see Figs. 1 and 9, par. [0046]); the first tube (tubing 77) coupled to the nutrition adapter (syringe connector 30) (see Fig. 1, par. [0045]-[0046]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Nordquist to include the reusable nutrition container including a rigid container connector defining external threads; a nutrition adapter including a collar including internal threads sized to directly engage the external threads of the rigid container connector; the first tube coupled to the nutrition adapter, as taught by Breitweiser, in order to provide the structure which fluidly connects the reusable nutrition container to the first tube (see Breitweiser par. [0045]-[0046]). Since Nordquist already teaches that the system is capable of gravity feeding (see Nordquist par. [0046], [0036], fluid from feeding container 246 can be delivered via pump 248 or simply gravity) and the modification in view of Breitweiser would simply add connection structures between the nutrition container and the first tube, the modification would still enable gravity feeding in the manner claimed.
However, modified Nordquist still fails to expressly state wherein the nutrition adapter, the first tube, the inline access port, the second tube, and the feeding tube adapter are permanently coupled together.
Koelper teaches a bolus feed delivery system (see Figs. 1B-2, par. [0023]) having multiple ports/adapters and tubing segments which are permanently coupled together (see par. [0022], [0032]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Nordquist to include permanently connecting the ports/adapters and the tubing segments of the system to each other, as taught by Koelper, in order to provide an alternative, fixed connection between the structures since both removable and permanent connections between ports/adapters and tubing segments are appropriate for these types of feeding systems (see Koelper par. [0022], [0032]). Since modified Nordquist teaches each of the nutrition adapter (Breitweiser, syringe connector 30), the first tube (Nordquist, administration tubing 242), the inline access port (Nordquist, Y-connector 220), the second tube (Nordquist, fluid delivery tubing 244), and the feeding tube adapter (Nordquist, proximal portion of connector apparatus 235), the modification would include that each of these structures would be permanently connected to each other in the manner claimed.
Regarding claim 10, modified Nordquist teaches the bolus feed delivery system of claim 1 substantially as claimed. Modified Nordquist further teaches wherein the inline access port (Nordquist, Y-connector 220) is formed as one piece with the nutrition adapter (Breitweiser, syringe connector 30), the first tube (Nordquist, administration tubing 242), the second tube (Nordquist, fluid delivery tubing 244), and the feeding tube adapter (Nordquist, proximal portion of connector apparatus 235) (see Koelper par. [0022], [0032], see previous modifications in rejection of claim 1 above in view of Breitweiser and Koelper).
Regarding claim 11, modified Nordquist teaches the bolus feed delivery system of claim 1 substantially as claimed. Modified Nordquist further teaches wherein the nutrition adapter (Breitweiser, syringe connector 30) includes: the collar (Breitweiser, outer skirt 44) extending distally from a top deck (Breitweiser, connector body 34) of the nutrition adapter (Breitweiser, syringe connector 30) (see previous modifications in view of Breitweiser in rejection of claim 1 above, see Breitweiser Fig. 9 and par. [0046], outer skirt 44 extends distally from the outer cylindrical surface of connector body 34); and a first inlet port (Breitweiser, valve portion 41) extending through the top deck (Breitweiser, connector body 34) and in fluid communication with the reusable nutrition container (see previous modifications in view of Breitweiser in rejection of claim 1 above, see Breitweiser Fig. 9 and par. [0046]).
However, modified Nordquist fails to expressly state that the nutrition adapter includes a second inlet port configured to couple with a secondary fluid source, the second inlet port extending through the top deck of the nutrition adapter and in fluid communication with the first inlet port and the reusable nutrition container; and a tethered cap configured to seal the second inlet port.
Koelper teaches a bolus feed delivery system for enteral feeding (see Figs. 1B-2, par. [0023]) comprising a nutrition adapter (Y-connector 104) comprising a second inlet port (connector 144) configured to couple with a secondary fluid source (see Figs. 1B-2, par. [0022]-[0023], [0028], [0036]-[0037]), the second inlet port (connector 144) extending through the top deck (outer cylindrical surface of Y-connector 104) of the nutrition adapter (Y-connector 104) and in fluid communication with the first inlet port (connector 124) and the reusable container (bag 40) (see Figs. 1B-2, par. [0022]-[0023], [0028], [0036]-[0037]); and a tethered cap (cap 150) configured to seal the second inlet port (connector 144) (see Figs. 1B-3, par. [0036]-[0039]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the bolus feed delivery system of modified Nordquist to include that the nutrition adapter includes a second inlet port configured to couple with a secondary fluid source, the second inlet port extending through the top deck of the nutrition adapter and in fluid communication with the first inlet port and the reusable nutrition container; and a tethered cap configured to seal the second inlet port, as taught by Koelper, in order to allow additional fluids to be supplied to or removed from the patient (see Koelper par. [0004]-[0005] and [0022]), and to seal the second inlet port to prevent ingress of unwanted materials when not in use (see Koelper par. [0038]).
Regarding claim 13, Nordquist discloses a kit for delivery of a bolus feed via enteral feeding (see Fig. 2A, par. [0046]), the kit comprising:
a reusable nutrition container (feeding container 246) including a fixed volume configured to hold a source of nutrition (see par. [0046]-[0047]) (see par. [0046], [0036]);
a bolus feed extension set (see Fig. 2A) comprising:
a first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047]);
an inline access port (Y-connector 220) attached to the first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047]);
a second tube (fluid delivery tubing 244) coupled to the inline access port (Y-connector 220) (see Fig. 2A, par. [0046]-[0047]);
a feeding tube adapter (proximal portion of connector apparatus 235) coupled to the second tube (fluid delivery tubing 244) and including a stem sized to be received in a receiving port (distal portion of connector apparatus 235) of an indwelling feeding tube (feeding tube 238) (see Fig. 2A and par. [0046]-[0047] which state that fluid delivery tubing 244 connects to feeding tube 238 via a standard enteral feeding connector apparatus 235 which appears to show a proximal “stem” portion inserted into a distal “receiving port” having a tethered cap; see further Fig. 1 and par. [0038] and [0045] which shows the standard enteral feeding connector apparatus as element 135 in Fig. 1 having two triangular portions with a proximal “stem” received in a distal “receiving port”);
a first clamp (roller clamp or other clamping mechanism 231) comprising a first clamp aperture sized to receive the first tube (administration tubing 242) and configured to restrict flow of fluid through the first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047], roller clamp or other clamping mechanism 231 is positioned over the administration tubing 242 such that it has an opening for receiving the administration tubing 242); and
a second clamp (clamping mechanism 139) comprising a second clamp aperture sized to receive the second tube (fluid delivery tubing 244) and configured to restrict flow of fluid through the second tube (fluid delivery tubing 244) (see Fig. 2A, par. [0038], [0054]-[0055], clamping mechanism 139 is positioned over the fluid delivery tubing 244 such that it has an opening for receiving the fluid delivery tubing 244); and
a support (support stand 130) engaging the reusable nutrition container (feeding container 246) in a position vertically above the receiving port to enable gravity feeding (see par. [0046], [0036], fluid from feeding container 246 can be delivered via pump 248 or simply gravity).
However, Nordquist fails to expressly state how the reusable nutrition container connects to the first tube. Specifically, Nordquist fails to state the reusable nutrition container including a container connection; the bolus feed extension set comprising a nutrition adapter including a collar configured to directly couple to the container connection; the first tube coupled to the nutrition adapter. Further, Nordquist fails to expressly state wherein the nutrition adapter, the first tube, the inline access port, the second tube, and the feeding tube adapter are permanently coupled together.
Breitweiser teaches a kit for delivery of a bolus feed (see Figs. 1 and 7-9, par. [0036]) comprising: a reusable nutrition container (syringe 14) including a container connection (female tip 24) (see Figs. 1 and 7-8, par. [0039], [0041]-[0042], [0045]-[0046]); a bolus feed extension set comprising a nutrition adapter (syringe connector 30) including a collar (outer skirt 44) configured to directly couple to the container connection (female tip 24) (see Figs. 1 and 9, par. [0046]); the first tube (tubing 77) coupled to the nutrition adapter (syringe connector 30) (see Fig. 1, par. [0045]-[0046]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of Nordquist to include the reusable nutrition container including a container connection; the bolus feed extension set comprising a nutrition adapter including a collar configured to directly couple to the container connection; the first tube coupled to the nutrition adapter, as taught by Breitweiser, in order to provide the structure which fluidly connects the reusable nutrition container to the first tube (see Breitweiser par. [0045]-[0046]).
However, modified Nordquist still fails to expressly state wherein the nutrition adapter, the first tube, the inline access port, the second tube, and the feeding tube adapter are permanently coupled together.
Koelper teaches a kit for delivery of a bolus feed (see Figs. 1B-2, par. [0023]) having multiple ports/adapters and tubing segments which are permanently coupled together (see par. [0022], [0032]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of modified Nordquist to include permanently connecting the ports/adapters and the tubing segments of the system to each other, as taught by Koelper, in order to provide an alternative, fixed connection between the structures since both removable and permanent connections between ports/adapters and tubing segments are appropriate for these types of feeding systems (see Koelper par. [0022], [0032]). Since modified Nordquist teaches each of the nutrition adapter (Breitweiser, syringe connector 30), the first tube (Nordquist, administration tubing 242), the inline access port (Nordquist, Y-connector 220), the second tube (Nordquist, fluid delivery tubing 244), and the feeding tube adapter (Nordquist, proximal portion of connector apparatus 235), the modification would include that each of these structures would be permanently connected to each other in the manner claimed.
Regarding claim 18, modified Nordquist teaches the kit of claim 13 substantially as claimed. Modified Nordquist further teaches wherein the nutrition adapter (Breitweiser, syringe connector 30) includes: the collar (Breitweiser, outer skirt 44) extending distally from a top deck (Breitweiser, connector body 34) of the nutrition adapter (Breitweiser, syringe connector 30) (see previous modifications in view of Breitweiser in rejection of claim 13 above, see Breitweiser Fig. 9 and par. [0046], outer skirt 44 extends distally from the outer cylindrical surface of connector body 34); and a first inlet port (Breitweiser, valve portion 41) extending through the top deck (Breitweiser, connector body 34) and in fluid communication with the reusable nutrition container (see previous modifications in view of Breitweiser in rejection of claim 13 above, see Breitweiser Fig. 9 and par. [0046]).
However, modified Nordquist fails to expressly state that the nutrition adapter includes a second inlet port configured to couple with a secondary fluid source, the second inlet port extending through the top deck of the nutrition adapter and in fluid communication with the first inlet port and the reusable nutrition container; and a tethered cap configured to seal the second inlet port.
Koelper teaches a kit for delivery of a bolus feed (see Figs. 1B-2, par. [0023]) comprising a nutrition adapter (Y-connector 104) comprising a second inlet port (connector 144) configured to couple with a secondary fluid source (see Figs. 1B-2, par. [0022]-[0023], [0028], [0036]-[0037]), the second inlet port (connector 144) extending through the top deck (outer cylindrical surface of Y-connector 104) of the nutrition adapter (Y-connector 104) and in fluid communication with the first inlet port (connector 124) and the reusable container (bag 40) (see Figs. 1B-2, par. [0022]-[0023], [0028], [0036]-[0037]); and a tethered cap (cap 150) configured to seal the second inlet port (connector 144) (see Figs. 1B-3, par. [0036]-[0039]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of modified Nordquist to include that the nutrition adapter includes a second inlet port configured to couple with a secondary fluid source, the second inlet port extending through the top deck of the nutrition adapter and in fluid communication with the first inlet port and the reusable nutrition container; and a tethered cap configured to seal the second inlet port, as taught by Koelper, in order to allow additional fluids to be supplied to or removed from the patient (see Koelper par. [0004]-[0005] and [0022]), and to seal the second inlet port to prevent ingress of unwanted materials when not in use (see Koelper par. [0038]).
Regarding claim 20, Nordquist discloses a method for delivering a bolus feed to a patient (see Fig. 2A, par. [0046]), the method comprising:
providing a reusable nutrition container (feeding container 246) including a fixed volume configured to hold a source of nutrition (see par. [0046]-[0047]) (see par. [0046], [0036]);
providing a bolus feed delivery system (see Fig. 2A) for enteral feeding (see Fig. 2A, par. [0046]) comprising:
a first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047]);
an inline access port (Y-connector 220) attached to the first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047]);
a second tube (fluid delivery tubing 244) coupled to the inline access port (Y-connector 220) (see Fig. 2A, par. [0046]-[0047]);
a feeding tube adapter (proximal portion of connector apparatus 235) coupled to the second tube (fluid delivery tubing 244) and including a stem sized to be received in a receiving port (distal portion of connector apparatus 235) of an indwelling feeding tube (feeding tube 238) (see Fig. 2A and par. [0046]-[0047] which state that fluid delivery tubing 244 connects to feeding tube 238 via a standard enteral feeding connector apparatus 235 which appears to show a proximal “stem” portion inserted into a distal “receiving port” having a tethered cap; see further Fig. 1 and par. [0038] and [0045] which shows the standard enteral feeding connector apparatus as element 135 in Fig. 1 having two triangular portions with a proximal “stem” received in a distal “receiving port”);
a first clamp (roller clamp or other clamping mechanism 231) comprising a first clamp aperture sized to receive the first tube (administration tubing 242) and configured to restrict flow of fluid through the first tube (administration tubing 242) (see Fig. 2A, par. [0046]-[0047], roller clamp or other clamping mechanism 231 is positioned over the administration tubing 242 such that it has an opening for receiving the administration tubing 242); and
a second clamp (clamping mechanism 139) comprising a second clamp aperture sized to receive the second tube (fluid delivery tubing 244) and configured to restrict flow of fluid through the second tube (fluid delivery tubing 244) (see Fig. 2A, par. [0038], [0054]-[0055], clamping mechanism 139 is positioned over the fluid delivery tubing 244 such that it has an opening for receiving the fluid delivery tubing 244);
inserting the stem of the feeding tube adapter (proximal portion of connector apparatus 235) into the receiving port (distal portion of connector apparatus 235) (see Fig. 2A and par. [0046]-[0047] which state that fluid delivery tubing 244 connects to feeding tube 238 via a standard enteral feeding connector apparatus 235 which appears to show a proximal “stem” portion inserted into a distal “receiving port” having a tethered cap; see further Fig. 1 and par. [0038] and [0045] which shows the standard enteral feeding connector apparatus as element 135 in Fig. 1 having two triangular portions with a proximal “stem” received in a distal “receiving port”); and
delivering the bolus feed to the patient from the reusable nutrition container (feeding container 246) through the bolus feed delivery system using only gravity (see par. [0046], [0036], fluid from feeding container 246 can be delivered via pump 248 or simply gravity).
However, Nordquist fails to expressly state how the reusable nutrition container connects to the first tube. Specifically, Nordquist fails to state the reusable nutrition container including a rigid container connector defining external threads; a nutrition adapter including a collar including internal threads sized to directly engage the external threads of the rigid container connector to enable gravity feeding; the first tube coupled to the nutrition adapter; and threading the collar of the nutrition adapter to the rigid container connector. Further, Nordquist fails to expressly state wherein the nutrition adapter, the first tube, the inline access port, the second tube, and the feeding tube adapter are permanently coupled together.
Breitweiser teaches a method for delivering a bolus feed to a patient (see Figs. 1 and 7-9, par. [0036]) comprising: a reusable nutrition container (syringe 14) including a rigid container connector (female tip 24) defining external threads (external thread 26) (see Figs. 1 and 7-8, par. [0039], [0041]-[0042], [0045]-[0046]); a nutrition adapter (syringe connector 30) including a collar (outer skirt 44) including internal threads (internal thread 46) sized to directly engage the external threads (external thread 26) of the rigid container connector (female tip 24) (see Figs. 1 and 9, par. [0046]); the first tube (tubing 77) coupled to the nutrition adapter (syringe connector 30) (see Fig. 1, par. [0045]-[0046]); and threading the collar (outer skirt 44) of the nutrition adapter (syringe connector 30) to the rigid container connector (female tip 24) (see Fig. 1, par. [0045]-[0046]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Nordquist to include the reusable nutrition container including a rigid container connector defining external threads; a nutrition adapter including a collar including internal threads sized to directly engage the external threads of the rigid container connector; the first tube coupled to the nutrition adapter, and threading the collar of the nutrition adapter to the rigid container connector, as taught by Breitweiser, in order to provide the structure which fluidly connects the reusable nutrition container to the first tube (see Breitweiser par. [0045]-[0046]).
However, modified Nordquist still fails to expressly state wherein the nutrition adapter, the first tube, the inline access port, the second tube, and the feeding tube adapter are permanently coupled together.
Koelper teaches a method for delivering a bolus feed to a patient (see Figs. 1B-2, par. [0023]) having multiple ports/adapters and tubing segments which are permanently coupled together (see par. [0022], [0032]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Nordquist to include permanently connecting the ports/adapters and the tubing segments of the system to each other, as taught by Koelper, in order to provide an alternative, fixed connection between the structures since both removable and permanent connections between ports/adapters and tubing segments are appropriate for these types of feeding systems (see Koelper par. [0022], [0032]). Since modified Nordquist teaches each of the nutrition adapter (Breitweiser, syringe connector 30), the first tube (Nordquist, administration tubing 242), the inline access port (Nordquist, Y-connector 220), the second tube (Nordquist, fluid delivery tubing 244), and the feeding tube adapter (Nordquist, proximal portion of connector apparatus 235), the modification would include that each of these structures would be permanently connected to each other in the manner claimed.
Claims 2-3, 6, 14, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nordquist et al. (US 2016/0067148 A1) in view of Breitweiser (US 2020/0282135 A1) and further in view of Koelper et al. (US 2016/0143815 A1), as applied to claims 1 and 13 above, and further in view of Durham (US 2014/0114259 A1).
Regarding claims 2 and 14, modified Nordquist teaches the bolus feed delivery system of claim 1 and the kit of claim 13, respectively, substantially as claimed. However, modified Nordquist fails to expressly state wherein the feeding tube adapter includes a feeding tube adapter body arranged parallel to the second tube, and wherein the stem is arranged at an angle of about 165 degrees to about 195 degrees relative to the feeding tube adapter body.
Durham teaches a bolus feed delivery system or a kit for delivery of a bolus feed (see Figs. 4-9, par. [0002], [0013], [0019]) wherein the feeding tube adapter (connector 420) includes a feeding tube adapter body (proximal end 424 and lip 427) arranged parallel to the second tube (extension tube 410), and wherein the stem (distal end 421 and middle section 426) is arranged at an angle of about 165 degrees to about 195 degrees relative to the feeding tube adapter body (proximal end 424 and lip 427) (see Fig. 4, par. [0027], the distal end 421 and middle section 426 are arranged at 180 degrees relative to the proximal end 424 and lip 427).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/kit of modified Nordquist to include wherein the feeding tube adapter includes a feeding tube adapter body arranged parallel to the second tube, and wherein the stem is arranged at an angle of about 165 degrees to about 195 degrees relative to the feeding tube adapter body, as taught by Durham, in order to further provide the structure of the feeding tube adapter and the receiving port of the indwelling feeding tube, to limit insertion of the feeding tube adapter into the receiving port, and to prevent reflux from exiting the receiving port (see Durham par. [0027]-[0028]).
Regarding claim 3, modified Nordquist teaches the bolus feed delivery system of claim 2 substantially as claimed. Modified Nordquist further teaches wherein the angle is about 180 degrees (see Durham Fig. 4, Durham par. [0027], the distal end 421 and middle section 426 are arranged at 180 degrees relative to the proximal end 424 and lip 427, see previous modifications in rejection of claim 2 above).
Regarding claims 6 and 16, modified Nordquist teaches the bolus feed delivery system of claim 1 and the kit of claim 13, respectively, substantially as claimed. However, modified Nordquist fails to expressly state wherein the feeding tube adapter comprises a male coupling configured to be received within a female coupling of the receiving port, wherein the male coupling comprises at least one rib protruding from an external surface of the stem.
Durham teaches a bolus feed delivery system or a kit for delivery of a bolus feed (see Figs. 4-9, par. [0002], [0013], [0019]) wherein the feeding tube adapter (connector 420) comprises a male coupling configured to be received within a female coupling of the receiving port (feeding port 220), wherein the male coupling comprises at least one rib (plurality of conical ridges 422) protruding from an external surface of the stem (distal end 421 and middle section 426) (see Figs. 4-5, par. [0027]-[0028]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the system/kit of modified Nordquist to include wherein the feeding tube adapter comprises a male coupling configured to be received within a female coupling of the receiving port, wherein the male coupling comprises at least one rib protruding from an external surface of the stem, as taught by Durham, in order to further provide the structure of the feeding tube adapter and the receiving port of the indwelling feeding tube, to limit insertion of the feeding tube adapter into the receiving port, and to prevent reflux from exiting the receiving port (see Durham par. [0027]-[0028]).
Regarding claim 19, modified Nordquist teaches the kit of claim 13 substantially as claimed. However, modified Nordquist fails to state wherein the support comprises a garment to be worn by a patient.
Durham teaches a kit for delivery of a bolus feed (see Figs. 4-9, par. [0002], [0013], [0019]) wherein the support (catheter securement device 700 and shirt 920) comprises a garment to be worn by a patient (see Fig. 9, par. [0029]-[0034], the catheter securement device 700 and shirt 920 are worn by the patient).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of modified Nordquist to include wherein the support comprises a garment to be worn by a patient, as taught by Durham, in order to secure the kit to the patient (see Durham par. [0032]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Nordquist et al. (US 2016/0067148 A1) in view of Breitweiser (US 2020/0282135 A1) and further in view of Koelper et al. (US 2016/0143815 A1), as applied to claim 1 above, and further in view of Frederick et al. (US 4,874,365 A).
Regarding claim 4, modified Nordquist teaches the bolus feed delivery system of claim 1 substantially as claimed. However, modified Nordquist fails to expressly state a solvent or adhesive bond between the first tube and the nutrition adapter.
Frederick teaches a bolus feed delivery system for enteral feeding (see Figs. 1-3, col. 1 lines 14-19, col. 3 lines 49-54) comprising a solvent or adhesive bond between the first tube (hollow tube 12) and the nutrition adapter (hollow adapter 16) (see Figs. 1-3, col. 3 lines 49-54, col. 4 lines 12-17).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the bolus feed delivery system of modified Nordquist to include a solvent or adhesive bond between the first tube and the nutrition adapter, as taught by Frederick, as a means to attach the first tube to the nutrition adapter (see Frederick col. 3 lines 49-54, col. 4 lines 12-17).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nordquist et al. (US 2016/0067148 A1) in view of Breitweiser (US 2020/0282135 A1) and further in view of Koelper et al. (US 2016/0143815 A1), as applied to claim 1 above, and further in view of Becker (US 2010/0036365 A1).
Regarding claim 5, modified Nordquist teaches the bolus feed delivery system of claim 1 substantially as claimed. However, modified Nordquist fails to expressly state a solvent or adhesive bond between the second tube and the feeding tube adapter.
Becker teaches a bolus feed delivery system for enteral feeding (see Fig. 1, par. [0047]) comprising a solvent or adhesive bond between the second tube (flexible connecting tube 3) and the feeding tube adapter (distal connecting piece 5) (see Figs. 1-3, par. [0053]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the bolus feed delivery system of modified Nordquist to include a solvent or adhesive bond between the second tube and the feeding tube adapter, as taught by Becker, as a means to attach the tube to the feeding tube adapter (see Becker par. [0053]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Nordquist et al. (US 2016/0067148 A1) in view of Breitweiser (US 2020/0282135 A1) and further in view of Koelper et al. (US 2016/0143815 A1), as applied to claim 13 above, further in view of Frederick et al. (US 4,874,365 A) and further in view of Becker (US 2010/0036365 A1).
Regarding claim 15, modified Nordquist teaches the kit of claim 13 substantially as claimed. However, modified Nordquist fails to expressly state a solvent or adhesive bond between the first tube and the nutrition adapter, and a solvent or adhesive bond between the second tube and the feeding tube adapter.
Frederick teaches a kit (see Figs. 1-3, col. 1 lines 14-19, col. 3 lines 49-54) comprising a solvent or adhesive bond between the first tube (hollow tube 12) and the nutrition adapter (hollow adapter 16) (see Figs. 1-3, col. 3 lines 49-54, col. 4 lines 12- 17).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of modified Nordquist to include a solvent or adhesive bond between the first tube and the nutrition adapter, as taught by Frederick, as a means to attach the first tube to the nutrition adapter (see Frederick col. 3 lines 49-54, col. 4 lines 12-17).
However, modified Nordquist still fails to expressly state a solvent or adhesive bond between the second tube and the feeding tube adapter
Becker teaches a kit (see Fig. 1, par. [0047]) comprising a solvent or adhesive bond between the second tube (flexible connecting tube 3) and the feeding tube adapter (distal connecting piece 5) (see Figs. 1-3, par. [0053]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the kit of modified Nordquist to include a solvent or adhesive bond between the second tube and the feeding tube adapter, as taught by Becker, as a means to attach the second tube to the feeding tube adapter (see Becker par. [0053]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 13, and 20 have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights