DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 08/22/2025. As directed by the amendment: Claims 1 and 6-7 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-14 are presently pending in the application.
Response to Arguments
Applicant's arguments filed 08/22/2025 have been fully considered but they are not persuasive.
Applicant argues, pages 5-6, that Durham discloses it is advantageous to provide a removable connection on a gastrostomy tube and therefore teaches away from the examiner’s combinations to add the adhesive connections disclosed in Booth and Russo. Examiner disagrees, Durham does not disclose it is advantageous to provide a removable connection. Durham discloses having a connector that may be removably coupled with an extension tube (parag. [0021]). There is no mention of advantageously having a removable connection. Examiner is still using Durham as the primary reference and a new ground of rejection is made in view of Flaherty (US 5312337) to teach the amendments to claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 6, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Durham (US 2014/0114259); in view of Flaherty (US 5312337).
Regarding Claim 1, Durham discloses a gastrostomy tube (second gastric feeding tube (200); Fig.2) for enteral nutrition or medication of a subject, comprising: a first flexible tube (tubular member (210)) (parag. [0018]) having an internal end positionable in vivo within the stomach of the subject and an external end positionable ex vivo (Figs.3 and 9), wherein the first flexible tube (210) has a main longitudinal channel (lumen along the tubular member (210) where the nourishment (such as food) is introduced through the feeding port (220)) (parag. [0014]) and a secondary longitudinal channel (lumen along the inflation tube that is inserted within the tubular member) (parag. [0014]), and wherein the main and secondary longitudinal channels are not in fluid communication with each other (the lumen along the tubular member (210) is different than the lumen along the inflation tube, so the lumen within the tubular member is not in fluid communication with the lumen within the inflation tube) (parag. [0014]) and run parallel to each other in a side-by-side spaced arrangement (the feeding lumen extend along the length of the tubular member and the inflation tube extend from a proximal end to the distal end of the lumen wall wherein the lumen wall surrounds the feeding lumen (parags. [0013]-[0014]); an internal retention device (balloon (230)) attached at or towards the internal end of the first flexible tube (the balloon (230) is located at the internal end of the tubular member (210) as seen in Figs.2-3 and 9) and in fluid communication with the secondary longitudinal channel (parag. [0014]); a substantially Y-shaped connector (balloon port (250) and feeding port (220)) attached to the external end of the first flexible tube (Fig.9), wherein the substantially Y-shaped connector has a first port (see annotated figure below), a second port (feeding port (220)) and a third port (balloon port (250)), wherein the external end of the first flexible tube is connected to the first port (Figs.2-3), the second port (220) is in fluid communication with the main longitudinal channel (parag. [0014]) and the third port (250) is in fluid communication with the secondary longitudinal channel (lumen along the inflation tube that is inserted within the tubular member) (parag. [0014]); and a second flexible tube (extension tube (410)) having a first end (where connector (420) is located; Fig.4) and a second end (where the feeding syringe interface is attached to the extension tube (410) as seen in Fig.6) and a conduit extending between the first end and the second end (a conduit extends within the extension tube (410) where food is delivered to the patient) (parag. [0034]), wherein the first end (421) of the second flexible tube (410) terminates inside the substantially Y-shaped connector (220) (the distal end (421) of the extension tube (410) terminates/is inserted inside the feeding port (220)) (parag. [0028]), wherein the first end (where connector (420) is located) of the second flexible tube (410) and the second port (220) of the substantially Y-shaped connector define a delivery channel extending between the internal end of the first flexible tube (210) and the second end of the second flexible tube (410) for delivering a nutrient or medicine to the subject (parag. [0034]), wherein the second end of the second flexible tube is attachable to a nutrient or medicine source (feeding syringe) (parag. [0029]).
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Durham does disclose a substantially Y-shaped connector has a wedge-shaped surface inside a first port that corresponds with and abuts a diagonally cut surface on an external end of a first flexible tube to ensure correct alignment of the external end of the first flexible tube in the first port so that a secondary longitudinal channel is aligned and arranged in fluid communication with a third port and a main longitudinal channel is aligned in fluid communication with a second port.
Flaherty teaches it was known in the art to have a connector 10 with a wedge-shaped surface 80 (see annotated figure below) inside a port of the connector 10, as seen in Fig.6, that corresponds and abuts an inclined/diagonally cut edge 97 of external sleeve 40 (lines 14-34 in column 8). Modifying the first port (see annotated figure above) of the Y-shaped connector of Durham with the wedge-shaped surface 80 of Flaherty and the external end of the tubular member 210 of Durham with the inclined/diagonally cut edge 97 of Flaherty would ensure alignment of the tubular member 210 and first port, since the wedge-shaped surface 80 corresponds and interacts with the inclined cut edge 97. The modification is fully capable of aligning the inflation lumen with the balloon port 250 (having fluid communication to inflate the balloon 230) (parag. [0014]) of Durham and aligning the feeding lumen with the feeding port 220 (having fluid communication with feeding syringe) (last sentence in parag. [0025]) of Durham. Therefore, the modification would be adding the wedge-shaped surface 80 and the inclined cut edge 97 of Flaherty to the first port (annotated in the figure above) of the Y-shaped connector and the tubular member 210 of Durham respectively. The connection between the wedge-shaped surface 80 and the inclined cut edge 97 would ensure alignment between the Y-shaped connector and the tubular member when Durham is modified with Flaherty.
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Durham to incorporate the teachings of Flaherty to have a substantially Y-shaped connector that has a wedge-shaped surface inside a first port that corresponds with and abuts a diagonally cut surface on an external end of a first flexible tube to ensure correct alignment of the external end of the first flexible tube in the first port so that a secondary longitudinal channel is aligned and arranged in fluid communication with a third port and a main longitudinal channel is aligned in fluid communication with a second port in order to provide an extra degree of leak-free compressive sealing between the connector and the catheter (lines 14-34 in column 8).
Regarding Claim 2, Durham as modified discloses the gastrostomy tube of claim 1, and further discloses comprising a feed connection port (feeding syringe interface (610); Fig.6) attached to the second end of the second flexible tube (Fig.6).
Regarding Claim 3, Durham as modified discloses the gastrostomy tube of claim 1, and further discloses comprising an external retention device (right-angle bolster (240)) adjustably mounted on the first flexible tube (Figs.2-3).
Regarding Claim 6, Durham as modified discloses the gastrostomy tube of claim 1, and further discloses wherein the main longitudinal channel and the secondary longitudinal channel are both surrounded by a single external tubing wall (feeding lumen wall (215)) that has a circular cross-section and a constant external diameter (the feeding lumen and the inflation lumen are surrounded by the feeding lumen wall 215 wherein the feeding lumen wall has a circular cross-section, as seen in the cross-section view of the second gastric feeding tube 200 in Fig.3, with a constant external diameter (no change in diameter length) as seen in Figs.2-3 and 5).
Regarding Claim 8, Durham as modified discloses the gastrostomy tube of claim 1, and further discloses wherein the internal retention device comprises a balloon (balloon (230)) having an elastic body with an interior void in fluid communication with the secondary longitudinal channel (parag. [0014]).
Regarding Claim 10, Durham as modified discloses a kit of parts comprising: a gastrostomy tube (200) according to claim 2; and a nutrient/medicine container attachable or attached to the gastrostomy tube (feeding syringe) via the second flexible tube (410) or the feed connection port (the feeding syringe is attached via the second gastric feeding tube (200) via the feeding syringe interface (610) attached on the extension tube (410)) (parag. [0029]).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Durham (US 2014/0114259) in view of Flaherty (US 5312337) and Millis (US 10426708).
Regarding Claim 4, Durham as modified discloses all the limitations of claim 1 above.
Durham does not appear to disclose the first flexible tube and the substantially Y-shaped connector are composed of a first material and the second flexible tube is composed of a second material which is different from the first material.
Millis teaches it was known in the art to have an inner tube (214; Fig.1) and head/connector (220) formed of the same material (e.g. silicone and/or polyurethane) (column 21, lines 22-29).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Durham to incorporate the teachings of Millis to have the first flexible tube and the substantially Y-shaped connector composed of a first material (same material) in order to form a stable connector (column 21, lines 22-29). Millis does not explicitly disclose the first material of the first flexible tube and the substantially Y-shaped connector is different from the second material of the second flexible tube.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have a first material of a first flexible tube and a substantially Y-shaped connector different from a second material of a second flexible tube, since selection of a known material on basis of its suitability for an intended use involves only routine skill in the art. The motivation for doing so would be to have a first material made to withstand in vivo conditions and a second material to withstand ex vivo conditions. See MPEP 2144.07.
Regarding Claim 5, Durham as modified discloses the gastrostomy tube of claim 4, and Millis further teaches wherein the first flexible tube and the substantially Y-shaped connector are formed as a single continuous part (column 21, lines 22-29).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Durham (US 2014/0114259) in view of Flaherty (US 5312337) and O’Hara (US 2003/0009152).
Regarding Claim 7, Durham as modified discloses all the limitations of claim 6 above.
Durham does not appear to disclose the main longitudinal channel has a substantially D-shaped cross-section and the secondary channel has a substantially circular cross-section.
O’Hara teaches it was known in the art to have a feeding lumen 143 (Figs.6-7) with a substantially D-shaped cross-section and a longitudinal filling lumen 145 with a circular cross-section (parag. [0075]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Durham to incorporate the teachings of O’Hara to have a main longitudinal channel with a substantially D-shaped cross-section and a secondary channel with as a substantially circular cross-section in order to have the appropriate cross-sections for the intended purpose of the device (parag. [0065]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Durham (US 2014/0114259) in view of Flaherty (US 5312337) and Ciannella (US 4698056).
Regarding Claim 9, Durham as modified discloses all the limitations of claim 1 above.
Durham does not appear to disclose the second flexible tube is at least 5 cm in length.
Ciannella teaches it was known in the art to have a 75 cm long feeding tube (36; Fig.1) (column 3, lines 48-50).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Durham to have a second flexible tube is at least 5 cm in length in order to reach the patient’s body and applicant appears to have placed no criticality on the claimed type of catheter (page 6, lines 19-26 in specification).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Durham (US 2014/0114259); in view of Flaherty (US 5312337) and Moss (US 5520662).
Regarding Claim 11, Durham as modified discloses all the limitations of claim 10 above.
Durham does not appear to disclose a first syringe attachable to the third port to supply fluid to or to remove fluid from the internal retention device.
Moss teaches it was known in the art to have a water-filled syringe attached to an inflation attachment (30; Fig.1) to supply fluid to balloon (34) (column 4, lines 20-27).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Durham to incorporate the teachings of Moss to have a first syringe attachable to the third port to supply fluid to or to remove fluid from the internal retention device in order to inflate the balloon in the patient’s body to anchor the device within the body.
Regarding Claim 12, Durham as modified discloses the kit of parts of claim 11, and Moss further teaches wherein the first syringe is preloaded with a predetermined quantity of sterile fluid (column 4, lines 20-27).
Regarding Claim 13, Durham as modified discloses the kit of parts of claim 10, and Moss further teaches comprising a second syringe (water-filled syringe) attachable to the delivery channel via the second flexible tube or the feed connection port (the water-filled syringe of Moss is modified to Durham to attach to the tubular member (210) via the balloon port (250) to inflate balloon (23) with sterile water).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Durham (US 2014/0114259) in view of Flaherty (US 5312337) and Russo (US 4944732).
Regarding Claim 14, Durham as modified discloses all the limitations of claim 1 above.
Durham does not appear to disclose a first end of a second flexible tube is permanently bonded by adhesive to a second port of a substantially Y-shaped connector such that a delivery channel is permanent delivery channel for delivering a nutrient or medicine to a subject.
Russo teaches it was known in the art to have a tubular portion (16; Fig.1) permanently bonded by a silicone adhesive to a fitting portion (18) (column 3, lines 44-57). The silicone adhesive of Russo would be modified between the feeding port (220) and the distal end (421) of the extension tube (410) of Durham, therefore, the delivery channel (extends between the internal end of the tubular member (210) and the second end (where the feeding syringe interface is attached to the extension tube (410)) of the extension tube (410)) would be a permanent delivery channel for delivering nutrients) (parags. [0014] and [0029]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Durham to incorporate the teachings of Russo to have a first end of a second flexible tube is permanently bonded by adhesive to a second port of a substantially Y-shaped connector such that a delivery channel is permanent delivery channel for delivering a nutrient or medicine to a subject in order to permanently secure the connection between the fitting portion and the tubular sleeve (column 3, lines 44-57).
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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/T.I./ Examiner, Art Unit 3783 /BHISMA MEHTA/ Supervisory Patent Examiner, Art Unit 3783