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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/8/2026 has been entered.
Response to Amendment
The amendment filed on 7/8/2026 has been entered. Claims 1-9 and 14-20 are pending in the application. Claims 10-13 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, 9, 14, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of Nordquist et al. (US 2016/0067148 A1) and further in view of Koelper et al. (US 2016/0143815 A1).
Regarding claim 1, Breitweiser discloses an enteral feeding system (see Figs. 1-9, par. [0036]-[0037]) comprising:
a reusable nutrition container (syringe 14) including a volume configured to hold a source of nutrition (see par. [0039]), and a rigid container connector (female tip 24) defining external threads (external thread 26) (see Figs. 1 and 7-8, par. [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 7-9, par. [0045]-[0046]);
a first tube (inlet tubing 77) coupled to the nutrition adapter (syringe connector 30) (see Fig. 1, par. [0037], [0046]-[0047]);
a cartridge (cassette 5) configured to be inserted into a peristaltic pump (pump 1) (see Figs. 1-2, par. [0036]-[0037]) and including a cartridge tube (tube 45) defining a cartridge inlet coupled to the first tube (inlet tubing 77) and a cartridge outlet (see Figs. 3 and 6, par. [0039]-[0041], tube 45 includes an inlet coupled to inlet tubing 77 and an outlet coupled to outlet tubing 83 via fitting 65);
a second tube (outlet tubing 83) coupled to the cartridge outlet (see Figs. 2-3 and 5-6, par. [0041]).
While Breitweiser teaches that the second tube (outlet tubing 83) leads to a patient for delivering fluid for enteral feeding (see par. [0036], [0039], [0048], [0066]), Breitweiser fails to state how exactly the second tube (outlet tubing 83) engages with the patient. Specifically, Breitweiser fails to state an inline access port coupled to the second tube; a third tube coupled to the inline access port; a feeding tube adapter coupled to the third tube and including a stem sized to be received in a receiving port of an indwelling feeding tube; a first clamp comprising a first clamp aperture sized to receive the second tube and configured to restrict flow of fluid through the second tube; and a second clamp comprising a second clamp aperture sized to receive the third tube and configured to restrict flow of fluid through the third tube, wherein the nutrition adapter, the first tube, the cartridge, the second tube, the inline access port, the third tube, and the feeding tube adapter are permanently coupled together.
Nordquist teaches an enteral feeding system (see Fig. 2A, par. [0046]) comprising an inline access port (Y-connector 220) coupled to the second tube administration tubing 242) (see Fig. 2A, par. [0046]-[0047]); a third 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 third 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 second tube (administration tubing 242) and configured to restrict flow of fluid through the second 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 third tube (fluid delivery tubing 244) and configured to restrict flow of fluid through the third 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).
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 enteral feeding system of Breitweiser to include an inline access port coupled to the second tube; a third tube coupled to the inline access port; a feeding tube adapter coupled to the third tube and including a stem sized to be received in a receiving port of an indwelling feeding tube; a first clamp comprising a first clamp aperture sized to receive the second tube and configured to restrict flow of fluid through the second tube; and a second clamp comprising a second clamp aperture sized to receive the third tube and configured to restrict flow of fluid through the third tube, as taught by Nordquist, in order to provide the structures for connecting the enteral feeding system to the patient for enteral feeding, allow connection to additional tubings, and assist in regulating flow through the tubing (see Nordquist par. [0046]-[0047]).
However, modified Breitweiser still fails to state wherein the nutrition adapter, the first tube, the cartridge, the second tube, the inline access port, the third tube, and the feeding tube adapter are permanently coupled together.
Koelper teaches an enteral feeding 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 Breitweiser 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 Breitweiser teaches each of the nutrition adapter (Breitweiser, syringe connector 30), the first tube (Breitweiser, inlet tubing 77), the cartridge (Breitweiser, cassette 5), the second tube (Breitweiser, outlet tubing 83), the inline access port (Nordquist, Y-connector 220), the third 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 9, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. Breitweiser further teaches wherein the cartridge tube (tube 45) extends in a U-shape from the cartridge inlet to the cartridge outlet (see Figs. 3 and 6, par. [0040]-[0042]), and wherein the cartridge comprises at least one securing portion (fitting 65) formed along the U-shape of the cartridge tube (tube 45) (see Figs. 3 and 6, par. [0040]-[0042]).
Regarding claim 14, Breitweiser discloses a kit for enteral feeding (see Figs. 1-9, par. [0036]-[0037]) comprising:
a reusable nutrition container (syringe 14) including a fixed volume configured to hold a source of nutrition (see par. [0039]), and a container connection (female tip 24) (see Figs. 1 and 7-8, par. [0045]-[0046]);
a feed extension set (see Figs. 1 and 7-9) including:
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 7-9, par. [0045]-[0046]);
a first tube (inlet tubing 77) coupled to the nutrition adapter (syringe connector 30) (see Fig. 1, par. [0037], [0046]-[0047]);
a cartridge (cassette 5) configured to be inserted into a peristaltic pump (pump 1) (see Figs. 1-2, par. [0036]-[0037]) and including a cartridge tube (tube 45) extending in a U-shape from a cartridge inlet coupled to the first tube (inlet tubing 77) and a cartridge outlet (see Figs. 3 and 6, par. [0039]-[0041], tube 45 includes an inlet coupled to inlet tubing 77 and an outlet coupled to outlet tubing 83 via fitting 65);
a second tube (outlet tubing 83) coupled to the cartridge outlet (see Figs. 2-3 and 5-6, par. [0041]).
While Breitweiser teaches that the second tube (outlet tubing 83) leads to a patient for delivering fluid for enteral feeding (see par. [0036], [0039], [0048], [0066]), Breitweiser fails to state how exactly the second tube (outlet tubing 83) engages with the patient. Specifically, Breitweiser fails to state an inline access port coupled to the second tube; a third tube coupled to the inline access port; a feeding tube adapter coupled to the third tube and including a stem sized to be received in a receiving port of an indwelling feeding tube; a first clamp comprising a first clamp aperture sized to receive the second tube and configured to restrict flow of fluid through the second tube; and a second clamp comprising a second clamp aperture sized to receive the third tube and configured to restrict flow of fluid through the third tube, wherein the nutrition adapter, the first tube, the cartridge, the second tube, the inline access port, the third tube, and the feeding tube adapter are permanently coupled together; and a support engaging the reusable nutrition container in proximity to a patient.
Nordquist teaches a kit for enteral feeding (see Fig. 2A, par. [0046]) comprising an inline access port (Y-connector 220) coupled to the second tube administration tubing 242) (see Fig. 2A, par. [0046]-[0047]); a third 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 third 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 second tube (administration tubing 242) and configured to restrict flow of fluid through the second 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 third tube (fluid delivery tubing 244) and configured to restrict flow of fluid through the third 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 proximity to a patient (see Fig. 2A, par. [0038], [0046], [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 Breitweiser to include an inline access port coupled to the second tube; a third tube coupled to the inline access port; a feeding tube adapter coupled to the third tube and including a stem sized to be received in a receiving port of an indwelling feeding tube; a first clamp comprising a first clamp aperture sized to receive the second tube and configured to restrict flow of fluid through the second tube; and a second clamp comprising a second clamp aperture sized to receive the third tube and configured to restrict flow of fluid through the third tube; and a support engaging the reusable nutrition container in proximity to a patient, as taught by Nordquist, in order to provide the structures for connecting the kit to the patient for enteral feeding, allow connection to additional tubings, assist in regulating flow through the tubing, and suspend the reusable nutrition container in a position (see Nordquist par. [0046]-[0047], [0053]).
However, modified Breitweiser still fails to state wherein the nutrition adapter, the first tube, the cartridge, the second tube, the inline access port, the third tube, and the feeding tube adapter are permanently coupled together.
Koelper teaches kit for enteral feeding (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 Breitweiser 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 Breitweiser teaches each of the nutrition adapter (Breitweiser, syringe connector 30), the first tube (Breitweiser, inlet tubing 77), the cartridge (Breitweiser, cassette 5), the second tube (Breitweiser, outlet tubing 83), the inline access port (Nordquist, Y-connector 220), the third 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 20, Breitweiser discloses a method for delivering enteral feed to a patient (see Figs. 1-9, par. [0036]-[0037]), the method comprising:
providing a reusable nutrition container (syringe 14) including a fixed volume configured to hold the enteral feed (see par. [0039]), and a rigid container connector (female tip 24) defining external threads (external thread 26) (see Figs. 1 and 7-8, par. [0045]-[0046]);
providing an enteral feeding system (see Figs. 1 and 7-8) comprising:
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 7-9, par. [0045]-[0046]);
a first tube (inlet tubing 77) coupled to the nutrition adapter (syringe connector 30) (see Fig. 1, par. [0037], [0046]-[0047]);
a cartridge (cassette 5) configured to be inserted into a peristaltic pump (pump 1) (see Figs. 1-2, par. [0036]-[0037]) and including a cartridge tube (tube 45) extending in a U-shape from a cartridge inlet coupled to the first tube (inlet tubing 77) and a cartridge outlet (see Figs. 3 and 6, par. [0039]-[0041], tube 45 includes an inlet coupled to inlet tubing 77 and an outlet coupled to outlet tubing 83 via fitting 65);
a second tube (outlet tubing 83) coupled to the cartridge outlet (see Figs. 2-3 and 5-6, par. [0041]);
threading the collar (outer skirt 44) of the nutrition adapter (syringe connector 30) to the rigid container connector (female tip 24) ((see Figs. 1 and 7-9, par. [0045]-[0046]));
arranging the cartridge (cassette 5) within the peristaltic pump (see Figs. 1-2, par. [0036]-[0037]); and
operating the peristaltic pump such that the enteral feed is delivered to the patient from the reusable nutrition container (syringe 14) through the enteral feeding system (see Figs. 1-2, par. [0036]-[0037]).
While Breitweiser teaches that the second tube (outlet tubing 83) leads to a patient for delivering fluid for enteral feeding (see par. [0036], [0039], [0048], [0066]), Breitweiser fails to state how exactly the second tube (outlet tubing 83) engages with the patient. Specifically, Breitweiser fails to state an inline access port coupled to the second tube; a third tube coupled to the inline access port; a feeding tube adapter coupled to the third tube and including a stem sized to be received in a receiving port of an indwelling feeding tube; a first clamp comprising a first clamp aperture sized to receive the second tube and configured to restrict flow of fluid through the second tube; and a second clamp comprising a second clamp aperture sized to receive the third tube and configured to restrict flow of fluid through the third tube, wherein the nutrition adapter, the first tube, the cartridge, the second tube, the inline access port, the third tube, and the feeding tube adapter are permanently coupled together; and inserting the stem of the feeding tube adapter into the receiving port.
Nordquist teaches a method for delivering enteral feed to a patient (see Fig. 2A, par. [0046]) comprising an inline access port (Y-connector 220) coupled to the second tube administration tubing 242) (see Fig. 2A, par. [0046]-[0047]); a third 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 third 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 second tube (administration tubing 242) and configured to restrict flow of fluid through the second 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 third tube (fluid delivery tubing 244) and configured to restrict flow of fluid through the third 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 inserting the stem of the feeding tube adapter (proximal portion of connector apparatus 235) into the receiving port (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”).
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 enteral feeding system of Breitweiser to include an inline access port coupled to the second tube; a third tube coupled to the inline access port; a feeding tube adapter coupled to the third tube and including a stem sized to be received in a receiving port of an indwelling feeding tube; a first clamp comprising a first clamp aperture sized to receive the second tube and configured to restrict flow of fluid through the second tube; and a second clamp comprising a second clamp aperture sized to receive the third tube and configured to restrict flow of fluid through the third tube; and inserting the stem of the feeding tube adapter into the receiving port, as taught by Nordquist, in order to provide the structures for connecting the enteral feeding system to the patient for enteral feeding, allow connection to additional tubings, and assist in regulating flow through the tubing (see Nordquist par. [0046]-[0047]).
However, modified Breitweiser still fails to state wherein the nutrition adapter, the first tube, the cartridge, the second tube, the inline access port, the third tube, and the feeding tube adapter are permanently coupled together.
Koelper teaches a method for delivering enteral 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 Breitweiser 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 Breitweiser teaches each of the nutrition adapter (Breitweiser, syringe connector 30), the first tube (Breitweiser, inlet tubing 77), the cartridge (Breitweiser, cassette 5), the second tube (Breitweiser, outlet tubing 83), the inline access port (Nordquist, Y-connector 220), the third 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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of Nordquist et al. (US 2016/0067148 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 2, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. However, modified Breitweiser fails to expressly state a solvent or adhesive bond between the first tube and the nutrition adapter.
Frederick teaches an enteral feeding system (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 system of modified Breitweiser 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 tube to the nutrition adapter (see Frederick col. 3 lines 49-54, col. 4 lines 12-17).
Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of Nordquist et al. (US 2016/0067148 A1) and further in view of Koelper et al. (US 2016/0143815 A1), as applied to claims 1 and 14 above, and further in view of Morris, Jr. et al. (US 2021/0236717 A1).
Regarding claim 3, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. However, modified Breitweiser fails to expressly state a solvent or adhesive bond between the first tube and the cartridge inlet and a solvent or adhesive bond between the second tube and the cartridge outlet.
Morris, Jr. teaches a feeding system (see Fig. 8D, abstract) comprising a solvent or adhesive bond between the first tube (one of tubings 64) and the cartridge inlet (one end of cassette 20) and a solvent or adhesive bond between the second tube (other of tubings 64) and the cartridge outlet (other end of cassette 20) (see Fig. 8D, par. [0165]-[0166]).
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 enteral feeding system of modified Breitweiser to include a solvent or adhesive bond between the first tube and the cartridge inlet and a solvent or adhesive bond between the second tube and the cartridge outlet, as taught by Morris, Jr. in order to eliminate the need for manually coupling the parts of the system, minimize stress on the parts of the system, and provide a sterilized, disposable system for the customer (see Morris, Jr. par. [0165]-[0166]).
Regarding claim 16, modified Breitweiser teaches the kit of claim 14 substantially as claimed. However, modified Breitweiser fails to expressly state a solvent or adhesive bond between the first tube and the cartridge inlet and a solvent or adhesive bond between the second tube and the cartridge outlet.
Morris, Jr. teaches a kit for feeding (see Fig. 8D, abstract) comprising a solvent or adhesive bond between the first tube (one of tubings 64) and the cartridge inlet (one end of cassette 20) and a solvent or adhesive bond between the second tube (other of tubings 64) and the cartridge outlet (other end of cassette 20) (see Fig. 8D, par. [0165]-[0166]).
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 Breitweiser to include a solvent or adhesive bond between the first tube and the cartridge inlet and a solvent or adhesive bond between the second tube and the cartridge outlet, as taught by Morris, Jr. in order to eliminate the need for manually coupling the parts of the system, minimize stress on the parts of the system, and provide a sterilized, disposable system for the customer (see Morris, Jr. par. [0165]-[0166]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of Nordquist et al. (US 2016/0067148 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 4, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. However, modified Breitweiser fails to expressly state a solvent or adhesive bond between the third tube and the feeding tube adapter.
Becker teaches an enteral feeding system (see Fig. 1, par. [0047]) comprising a solvent or adhesive bond between the third 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 system of modified Breitweiser to include a solvent or adhesive bond between the third 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]).
Claims 5-6 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of Nordquist et al. (US 2016/0067148 A1) and further in view of Koelper et al. (US 2016/0143815 A1), as applied to claims 1 and 14 above, and further in view of MacHold et al. (US 2003/0135252 A1).
Regarding claim 5, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. Breitweiser further teaches wherein the cartridge tube (tube 45) is formed from a first material (see Fig. 3, par. [0003], [0039]), wherein at least one of the first tube (inlet tubing 77) or the second tube (outlet tubing 83) is formed from a second material (see Figs. 1-3, inlet tubing 77, outlet tubing 83, and tube 45 are separate pieces of material).
However, modified Breitweiser fails to expressly state wherein the first material and the second material are different materials.
MacHold teaches a system (see Fig. 9) wherein the different tubings (lines 428 and 426) can be made of different flexible materials (see par. [0115]).
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 Breitweiser to include wherein the first material and the second material are different materials, as suggested by MacHold, because MacHold teaches that different materials are suitable for fluid delivery as long as they are flexible and compressible (see MacHold par. [0115]).
Regarding claim 6, modified Breitweiser teaches the enteral feeding system of claim 5 substantially as claimed. Modified Breitweiser further teaches wherein the first material (see MacHold par. [0115], see previous modifications in rejection of claim 5 above) and the second material (see MacHold par. [0115], see previous modifications in rejection of claim 5 above) are each flexible materials (see MacHold Fig. 9, par. [0115], see previous modifications in rejection of claim 5 above).
Regarding claim 17, modified Breitweiser teaches the kit of claim 14 substantially as claimed. Breitweiser further teaches wherein the cartridge tube (tube 45) is formed from a first material (see Fig. 3, par. [0003], [0039]), wherein at least one of the first tube (inlet tubing 77) or the second tube (outlet tubing 83) is formed from a second material (see Figs. 1-3, inlet tubing 77, outlet tubing 83, and tube 45 are separate pieces of material).
However, modified Breitweiser fails to expressly state wherein the first material and the second material are different materials.
MacHold teaches a kit (see Fig. 9) wherein the different tubings (lines 428 and 426) can be made of different flexible materials (see par. [0115]).
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 Breitweiser to include wherein the first material and the second material are different materials, as suggested by MacHold, because MacHold teaches that different materials are suitable for fluid delivery as long as they are flexible and compressible (see MacHold par. [0115]).
Regarding claim 18, modified Breitweiser teaches the kit of claim 17 substantially as claimed. Modified Breitweiser further teaches wherein the first material (see MacHold par. [0115], see previous modifications in rejection of claim 17 above) and the second material (see MacHold par. [0115], see previous modifications in rejection of claim 17 above) are each flexible materials (see MacHold Fig. 9, par. [0115], see previous modifications in rejection of claim 17 above).
Claims 7-8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of Nordquist et al. (US 2016/0067148 A1) and further in view of Koelper et al. (US 2016/0143815 A1), as applied to claims 1 and 14 above, and further in view of McMichael et al. (US 2003/0225369 A1).
Regarding claim 7, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. However, modified Breitweiser 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.
McMichael teaches an enteral feeding system (see Figs. 3, 4c, and 7-7A, par. [0001], [0053]) comprising a feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) comprising a male coupling configured to be received within a female coupling of the receiving port (head 62), wherein the male coupling comprises at least one rib (finger 100) protruding from an external surface of the stem (leg 98) (see Figs. 3, 4C, and 7-7A, par. [0044] and [0053]-[0055]).
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 enteral feeding system of modified Breitweiser 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 McMichael, in order to provide the structure for receiving and aligning the feeding tube adapter within the receiving port (see McMichael par. [0055]).
Regarding claims 8 and 19, modified Breitweiser teaches the enteral feeding system of claim 1 and the kit of claim 14, respectively, substantially as claimed. However, modified Breitweiser fails to expressly state wherein the feeding tube adapter includes a feeding tube adapter body arranged parallel to the third tube, and wherein the stem is arranged at an angle of about 70 degrees to about 110 degrees relative to the feeding tube adapter body.
McMichael teaches an enteral feeding system and a kit for enteral feeding (see Figs. 3, 4c, and 7-7A, par. [0001], [0053]) wherein the feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) includes a feeding tube adapter body (portion of adapter at distal end 94 which receives the tube and from which the leg 98 extends) arranged parallel to the third tube (tube connecting proximal end 92 and distal end 94 of adapter 90), and wherein the stem (leg 98) is arranged at an angle of about 70 degrees to about 110 degrees relative to the feeding tube adapter body (portion of adapter at distal end 94 which receives the tube and from which the leg 98 extends) (see Figs. 7-7A, the leg 98 extends 90 degrees relative to the portion of the adapter at the distal end 94 which receives the tube).
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 enteral feeding system and the kit of modified Breitweiser to include wherein the feeding tube adapter includes a feeding tube adapter body arranged parallel to the third tube, and wherein the stem is arranged at an angle of about 70 degrees to about 110 degrees relative to the feeding tube adapter body, as taught by McMichael, in order to provide the structure for receiving and aligning the feeding tube adapter within the receiving port (see McMichael par. [0055]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of Nordquist et al. (US 2016/0067148 A1) and further in view of Koelper et al. (US 2016/0143815 A1), as applied to claim 14 above, and further in view of Hudson et al. (US 2005/0224534 A1).
Regarding claim 15, modified Breitweiser teaches the kit of claim 14 substantially as claimed. However, modified Breitweiser fails to state wherein the support comprises a bag wearable by the patient.
Hudson teaches a kit for enteral feeding (see Figs. 1-4, par. [0043]) comprising a support (apparatus 20) engaging the reusable nutrition container (enteral feeding container 42) in proximity to a patient (see Figs. 1-4, par. [0043]-[0044], [0059]), wherein the support (apparatus 20) comprises a bag wearable by the patient (see Fig. 1, par. [0010]-[0011]).
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 Breitweiser to include that the support comprises a bag wearable by the patient, as taught by Hudson, in order to create an ergonomically designed system that facilitates ease of use by the patient and increases patient comfort (see Hudson par. [0010]).
Response to Arguments
Applicant’s arguments with respect to claims 1, 14, 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
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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