DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed on 3/10/2026 has been entered. Claims 1-20 are pending in the application. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 12/10/2025.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 7-9, 14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of McMichael et al. (US 2003/0225369 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]); and
wherein the nutrition adapter (syringe connector 30), the first tube (inlet tubing 77), the cartridge (cassette 5), and the second tube (outlet tubing 83), are formed as one piece (see Figs. 1-3, par. [0042], [0046]-[0047]).
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 a feeding tube adapter coupled to the second tube and including a stem sized to be received in a receiving port of an indwelling feeding tube, wherein the feeding tube adapter is formed as one piece with the nutrition adapter, the first tube, the cartridge, and the second tube.
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) coupled to the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) and including a stem (leg 98) sized to be received in a receiving port (head 62) of an indwelling feeding tube (catheter 60) (see par. [0044], [0053]-[0055]), wherein the feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) is formed as one piece with the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) (see Figs. 7-7A, par. [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 Breitweiser to include a feeding tube adapter coupled to the second tube and including a stem sized to be received in a receiving port of an indwelling feeding tube, wherein the feeding tube adapter is formed as one piece with the second tube, as taught by McMichael, in order to provide the structure for the system to engage with a feeding tube for enteral feeding for the patient (see McMichael par. [0001], [0044], and [0053]-[0055]). Since Breitweiser teaches that the nutrition adapter (syringe connector 30), the first tube (inlet tubing 77), the cartridge (cassette 5), and the second tube (outlet tubing 83), are formed as one piece (see Figs. 1-3, par. [0042], [0046]-[0047]) and McMichael teaches that the feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) is formed as one piece with the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) (see Figs. 7-7A, par. [0053]-[0055]), this modification further teaches that the nutrition adapter, the first tube, the cartridge, the second tube, and the feeding tube adapter are formed as one piece.
Regarding claim 7, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. Modified Breitweiser further teaches wherein the feeding tube adapter (McMichael, adapter at distal end 94, see Figs. 7-7A) comprises a male coupling configured to be received within a female coupling of the receiving port (McMichael, head 62), wherein the male coupling comprises at least one rib (McMichael, finger 100) protruding from an external surface of the stem (McMichael, leg 98) (see McMichael Figs. 3, 4C, and 7-7A, par. [0044] and [0053]-[0055], see previous modifications in rejection of claim 1 above).
Regarding claim 8, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. Modified Breitweiser further teaches wherein the feeding tube adapter (McMichael, adapter at distal end 94, see Figs. 7-7A) includes a feeding tube adapter body (McMichael, portion of adapter at distal end 94 which receives the tube and from which the leg 98 extends) arranged parallel to the second tube (McMichael, tube connecting proximal end 92 and distal end 94 of adapter 90), and wherein the stem (McMichael, leg 98) is arranged at an angle of about 70 degrees to about 110 degrees relative to the feeding tube adapter body (McMichael, portion of adapter at distal end 94 which receives the tube and from which the leg 98 extends) (see McMichael 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, see previous modifications in rejection of claim 1 above).
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 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. 1-3) 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 (see Fig. 3) 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]); and
wherein the nutrition adapter (syringe connector 30), the first tube (inlet tubing 77), the cartridge (cassette 5), and the second tube (outlet tubing 83), are formed as one piece (see Figs. 1-3, par. [0042], [0046]-[0047]); and
a support (pump support 16 and syringe holder 62) engaging the reusable nutrition container (syringe 14) in proximity to a patient (see Fig. 1, par. [0039], [0044]).
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 a feeding tube adapter coupled to the second tube and including a stem sized to be received in a receiving port of an indwelling feeding tube, wherein the feeding tube adapter is formed as one piece with the nutrition adapter, the first tube, the cartridge, and the second tube.
McMichael teaches a kit for enteral feeding (see Figs. 3, 4C, and 7-7A, par. [0001], [0053]) comprising a feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) coupled to the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) and including a stem (leg 98) sized to be received in a receiving port (head 62) of an indwelling feeding tube (catheter 60) (see par. [0044], [0053]-[0055]), wherein the feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) is formed as one piece with the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) (see Figs. 7-7A, par. [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 kit of Breitweiser to include a feeding tube adapter coupled to the second tube and including a stem sized to be received in a receiving port of an indwelling feeding tube, wherein the feeding tube adapter is formed as one piece with the second tube, as taught by McMichael, in order to provide the structure for the system to engage with a feeding tube for enteral feeding for the patient (see McMichael par. [0001], [0044], and [0053]-[0055]). Since Breitweiser teaches that the nutrition adapter (syringe connector 30), the first tube (inlet tubing 77), the cartridge (cassette 5), and the second tube (outlet tubing 83), are formed as one piece (see Figs. 1-3, par. [0042], [0046]-[0047]) and McMichael teaches that the feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) is formed as one piece with the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) (see Figs. 7-7A, par. [0053]-[0055]), this modification further teaches that the nutrition adapter, the first tube, the cartridge, the second tube, and the feeding tube adapter are formed as one piece.
Regarding claim 19, modified Breitweiser teaches the kit of claim 14 substantially as claimed. Modified Breitweiser further teaches wherein the feeding tube adapter (McMichael, adapter at distal end 94, see Figs. 7-7A) includes a feeding tube adapter body (McMichael, portion of adapter at distal end 94 which receives the tube and from which the leg 98 extends) arranged parallel to the second tube (McMichael, tube connecting proximal end 92 and distal end 94 of adapter 90), and wherein the stem (McMichael, leg 98) is arranged at an angle of about 70 degrees to about 110 degrees relative to the feeding tube adapter body (McMichael, portion of adapter at distal end 94 which receives the tube and from which the leg 98 extends) (see McMichael 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, see previous modifications in rejection of claim 14 above).
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 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. 1-3) 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 (see Fig. 3) 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]); and
wherein the nutrition adapter (syringe connector 30), the first tube (inlet tubing 77), the cartridge (cassette 5), and the second tube (outlet tubing 83), are formed as one piece (see Figs. 1-3, par. [0042], [0046]-[0047]);
threading the collar (outer skirt 44) of the nutrition adapter (syringe connector 30) to the rigid container connector (female tip 24) (see par. [0046]);
arranging the cartridge (cassette 5) within the peristaltic pump (pump 1) (see par. [0036]-[0037]); and
operating the peristaltic pump (pump 1) such that the enteral feed is delivered to the patient from the reusable nutrition container (syringe 14) through the enteral feeding system (see Figs. 1-3, par. [0036]-[0037], [0039], [0042]).
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 a feeding tube adapter coupled to the second tube and including a stem sized to be received in a receiving port of an indwelling feeding tube, wherein the feeding tube adapter is formed as one piece with the nutrition adapter, the first tube, the cartridge, and the second tube; and inserting the stem of the feeding tube adapter into the receiving port.
McMichael teaches method for delivering enteral feed to a patient (see Figs. 3, 4C, and 7-7A, par. [0001], [0053]) comprising a feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) coupled to the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) and including a stem (leg 98) sized to be received in a receiving port (head 62) of an indwelling feeding tube (catheter 60) (see par. [0044], [0053]-[0055]), wherein the feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) is formed as one piece with the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) (see Figs. 7-7A, par. [0053]-[0055]); and inserting the stem (leg 98) of the feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) into the receiving port (head 62) (see Figs. 4C and 7-7A, par. [0044], [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 method of Breitweiser to include a feeding tube adapter coupled to the second tube and including a stem sized to be received in a receiving port of an indwelling feeding tube, wherein the feeding tube adapter is formed as one piece with the second tube; and inserting the stem of the feeding tube adapter into the receiving port, as taught by McMichael, in order to provide the structure for the method to engage with a feeding tube for enteral feeding for the patient (see McMichael par. [0001], [0044], and [0053]-[0055]). Since Breitweiser teaches that the nutrition adapter (syringe connector 30), the first tube (inlet tubing 77), the cartridge (cassette 5), and the second tube (outlet tubing 83), are formed as one piece (see Figs. 1-3, par. [0042], [0046]-[0047]) and McMichael teaches that the feeding tube adapter (adapter at distal end 94, see Figs. 7-7A) is formed as one piece with the second tube (tube connecting proximal end 92 and distal end 94 of adapter 90) (see Figs. 7-7A, par. [0053]-[0055]), this modification further teaches that the nutrition adapter, the first tube, the cartridge, the second tube, and the feeding tube adapter are formed as one piece.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of McMichael et al. (US 2003/0225369 A1), as applied to claim 1 above, 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, 10, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of McMichael et al. (US 2003/0225369 A1), as applied to claims 1 and 14 above, 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 10, modified Breitweiser teaches the enteral feeding system of claim 1. Modified Breitweiser further teaches an inline access port (Breitweiser, second attachment portion 75B and other inlet tubing 77 with flushing source) (Breitweiser, see Figs. 1 and 6, par. [0041]), wherein 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 feeding tube adapter (McMichael, adapter at distal end 94, see Figs. 7-7A), and the inline access port (Breitweiser, second attachment portion 75B and other inlet tubing 77 with flushing source) are formed as one piece (Breitweiser, see par. [0041]-[0042], see previous modifications in rejection of claim 1 above).
However, modified Breitweiser fails to expressly state wherein the nutrition adapter, the first tube, the cartridge, the second tube, the feeding tube adapter, and the inline access port are irremovably formed as one piece.
Morris, Jr. teaches a feeding system (see Fig. 8D, abstract) wherein the first tube (one of tubings 64), the cartridge (cassette 20), the second tube (other of tubings 64) are irremovably formed as one piece with the other connectors/adapters/ports of the system (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 wherein the nutrition adapter, the first tube, the cartridge, the second tube, the feeding tube adapter, and the inline access port are irremovably formed as one piece, as suggested 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 13, modified Breitweiser teaches the enteral feeding system of claim 1. However, modified Breitweiser fails to expressly state the wherein the nutrition adapter, the first tube, the cartridge, the second tube, and the feeding tube adapter are irremovably formed as one piece.
Morris, Jr. teaches a feeding system (see Fig. 8D, abstract) wherein the first tube (one of tubings 64), the cartridge (cassette 20), the second tube (other of tubings 64) are irremovably formed as one piece with the other connectors/adapters of the system (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 wherein the nutrition adapter, the first tube, the cartridge, the second tube, and the feeding tube adapter are irremovably formed as one piece, as suggested 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 McMichael et al. (US 2003/0225369 A1), as applied to claim 1 above, further in view of Becker (US 2010/0036365 A1).
Regarding claim 4, modified Breitweiser teaches the enternal feeding system of claim 1 substantially as claimed. However, modified Breitweiser fails to expressly state a solvent or adhesive bond between the second 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 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 system of modified Breitweiser 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]).
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 McMichael et al. (US 2003/0225369 A1), as applied to claims 1 and 14 above, 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).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of McMichael et al. (US 2003/0225369 A1), further in view of Morris, Jr. et al. (US 2021/0236717 A1), as applied to claim 10 above, and further in view of Durham (US 2014/0114259 A1).
Regarding claim 11, modified Breitweiser teaches the enteral feeding system of claim 10 substantially as claimed. Breitweiser further teaches a first flow controller (pumping unit 23) positioned between the cartridge outlet (where tube 45 connects to fitting 65 and outlet tubing 83) and the inline access port (second attachment portion 75B and other inlet tubing 77 with flushing source) (see Figs. 1, 3, and 6, par. [0038]-[0039], [0041]).
However, modified Breitweiser fails to state a second flow controller positioned between the inline access port and the feeding tube adapter.
Durham teaches an enteral feeding system (see Figs. 4-9, par. [0002], [0013], [0019]) comprising a second flow controller (adjustable tube clamp 630) positioned between the inline access port (feeding syringe interface 610) and the feeding tube adapter (connector 420) (see Figs. 6 and 8, par. [0029], [0034]).
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 second flow controller positioned between the inline access port and the feeding tube adapter, as taught by Durham, in order to further adjustably control the flow through the system (see Durham par. [0029] and [0034]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Breitweiser et al. (US 2020/0282135 A1) in view of McMichael et al. (US 2003/0225369 A1), as applied to claim 1 above, further in view of Nordquist et al. (US 2016/0067148 A1).
Regarding claim 12, modified Breitweiser teaches the enteral feeding system of claim 1 substantially as claimed. However, modified Breitweiser fails to state a first flow controller positioned on the first tube, and a second flow controller positioned on the second tube.
Nordquist teaches an enteral feeding system (see Fig. 1, par. [0036], [0038]) comprising a first flow controller (administration tube set clamp 150) positioned on the first tube (see Fig. 1, tube between enteral feeding container 146 and enteral feeding pump 148) (see Fig. 1, par. [0036]), and a second flow controller (nutrient supply line clamping mechanism 139) positioned on the second tube (fluid delivery tubing 144) (see Fig. 1, par. [0038], [0054]-[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 system of modified Breitweiser to include a first flow controller positioned on the first tube, and a second flow controller positioned on the second tube, as taught by Nordquist, in order to selectively control the flow between different portions of the system (see Nordquist par. [0036], [0038], [0054]-[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 McMichael et al. (US 2003/0225369 A1), as applied to claim 14 above, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783