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 .
Claim Rejections - 35 USC § 102
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.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-18, 21, 23-25, and 31-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (US 20190015241 A1), hereinafter referred to as “Lin”.
Regarding Claim 16, Lin teaches an ostomy bag device (see Abstract; Figure 3), comprising:
an expandable reservoir (1) extending from a first end (base 110) to a second end (upper member 140) and defining a space therewithin (see Figure 1);
a first connector connected to the first end of the reservoir (connector 300 connected to base 110) and configured to engage an opening extending through a wall at an end of an intestine so that intestinal contents flowing from the end of the intestine are received and collected within the reservoir (see Paragraph [0034]); and
a second connector connected to the second end of the reservoir (connection 240) and configured to engage an exit location via which contents collected within the reservoir are to be drained to an exterior of a patient body (a second aperture to connect to an external connection 240 arranged to connect to a tube 410 through which the contents of inner bag 200 are removed, see Paragraph [0031]), the second connector including a control element movable between a closed configuration, in which contents of the reservoir are prevented from flowing there past (a cover 170 covers upper external tube 410 preventing flow, see Paragraph [0039]; Figure 10), and an open configuration, in which contents of the reservoir are permitted to flow there past to drain the reservoir (such that when cover 170 is removed, the contents of inner bag 200 or container 100 may be removed, preferably by applying pressure onto container 100, see Paragraph [0039]).
Regarding Claim 17, Lin further teaches a sensor positioned along the reservoir and configured to detect a level of fill thereof (device 1 may include one or more sensors to detect the fullness, pressure, and/or weight of the inner bag 200 or container 100, see Paragraph [0040]).
Regarding Claim 18, Lin further teaches wherein the sensor includes one of a pressure sensor and a deformation sensor (pressure sensor, see Paragraph [0040]).
Regarding Claim 21, Lin further teaches wherein one of the first and second connectors is connected to the first and second ends of the reservoir, respectively, via a tubing (base 110 is connected to the connector 300 via outer tubing 350, see Figure 3).
Regarding Claim 23, Lin further teaches wherein the reservoir is formed of a biocompatible and expandable material (container 100 may be manufactured from a variety of material. A preferred material is silicone. Other non-limiting examples include nylon, polypropylene, and titanium. Preferably, at least for a device 1 being implanted in a user's body, container 100 is made of a material stable as an implant. Furthermore, container 100 is preferably flexible enough to bend inward and squeeze an inner bag 200 therein when pressured is applied inward onto container 100, for example, when emptying inner bag 200, see Paragraph [0030]).
Regarding Claim 24, Lin further teaches wherein the biocompatible and expandable material includes silicone (a preferred material is silicone, see Paragraph [0030]).
Regarding Claim 25, Lin further teaches wherein the reservoir is deformable from an initial, unexpanded configuration toward an expanded configuration as the intestinal contents are received therein (preferably, inner bag 200 is collapsible, expanding as contents enter it, see Paragraph [0031]).
Regarding Claim 31, Lin teaches a method for treating an intestine (using an ostomy pouching device for the removal of biological waste from a patient, see Abstract), comprising:
engaging a first connector (300) connected to a first end (base 110) of a reservoir (device 1) with an opening extending through a wall at an end of the intestine so that intestinal contents flowing from the end of the intestine are received and collected within the reservoir (bowel connector 300 to connect to the user's bowel through which contents enter inner bag 200 from the user's bowels, see Paragraph [0034]); and
engaging a second connector (connection 240) connected to a second end of the reservoir (upper member 140) to an exit location (upper aperture 150), the second connector including a control element (cover 170) movable between an open configuration, in which contents of the reservoir are permitted to flow through the control element, through the exit location, to an exterior of a user body (such that when cover 170 is removed, the contents of inner bag 200 or container 100 may be removed, preferably by applying pressure onto container 100, see Paragraph [0039]), and a closed configuration, in which contents of the reservoir are prevented from flowing through the control element (a cover 170 covers upper external tube 410 preventing flow, see Paragraph [0039]; Figure 10).
Regarding Claim 32, Lin further teaches detecting a level of fill of the reservoir to determine whether to drain the reservoir (device 1 may include one or more sensors to detect the fullness, pressure, and/or weight of the inner bag 200 or container 100, see Paragraph [0040]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19-20 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 20190015241 A1) in view of Scanlon (US 20070207186 A1).
Regarding Claim 19, Lin teaches all of the limitations as discussed above in claim 16. However, Lin does not explicitly disclose wherein one of the first connector and the second connector includes a self-expanding mesh coil.
Scanlon teaches a more durable expanded material that enables thinner wall thicknesses and a more flexible reinforcement suitable for stenting. The present invention is especially useful in the construction of grafts, stents, and stent-grafts which are used in colostomy or ostomy procedures, see Paragraph [0161]) wherein one of the first connector and the second connector includes a self-expanding mesh coil (expanded material 12, see Figure 1).
Lin and Scanlon are analogous art because both teach an ostomy device having material configured to be implanted in the body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first connector and the second connector and further include a self-expanding mesh coil, as taught by Scanlon. Scanlon teaches its beneficial for a reinforcement material suitable for stenting that has improved flexibility; a less complex manufacturing process; a wall thickness of varying thickness to reduce stress concentrations at the juncture between the stent and the passageway in which it is installed; and an ability to be easily produced in a large variety of sizes so that less stents are required by procedure (see Paragraph [0019]).
Regarding Claim 20, Lin and Scanlon teach all of the limitations as discussed above in claim 19 and Scanlon further teaches wherein the self-expanding mesh coil includes a first flange at a first end thereof (first end 20, see Figure 3) and a second flange at a second end thereof (second end 22), the first and second flanges configured to receive a portion of the wall of the intestine therebetween (to extend in a ostomy device/procedure, see Paragraph [0161]).
Regarding Claim 34, Lin teaches all of the limitations as discussed above in claim 31. However, Lin does not explicitly disclose wherein engaging the first connector with the opening extending through the wall of the intestine includes deploying a self-expanding mesh coil.
Scanlon teaches a more durable expanded material that enables thinner wall thicknesses and a more flexible reinforcement suitable for stenting; the present invention is especially useful in the construction of grafts, stents, and stent-grafts which are used in colostomy or ostomy procedures, see Paragraph [0161]), and deploying a self-expanding mesh coil (expanded material 12, see Figure 1).
Lin and Scanlon are analogous art because both teach an ostomy device having material configured to be implanted in the body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first connector and the second connector and further include wherein engaging the first connector with the opening extending through the wall of the intestine includes a self-expanding mesh coil, as taught by Scanlon. Scanlon teaches its beneficial for a reinforcement material suitable for stenting that has improved flexibility; a less complex manufacturing process; a wall thickness of varying thickness to reduce stress concentrations at the juncture between the stent and the passageway in which it is installed; and an ability to be easily produced in a large variety of sizes so that less stents are required by procedure (see Paragraph [0019]).
Claims 22, 26-28, 30, 33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (US 20190015241 A1) in view of Forsell (US 20230201583 A1).
Regarding Claim 22, Lin teaches all of the limitations as discussed above in claim 16. However, Lin does not explicitly disclose wherein the control element includes one of a valve and an artificial sphincter.
Forsell teaches a system is provided that acts on an intestinal reservoir (140, see Figure 1A) having a second connector (non-modified terminate section 80) including a control element (valve section 61,62, and 63) wherein the control element includes one of a valve and an artificial sphincter (valves 61,62, and 63).
Lin and Forsell are analogous art because both teach a system and method for treating a patient having a disorder related to the patient’s intestine.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the control element of Lin and further include wherein the control element includes one of a valve and an artificial sphincter, as taught by Forsell. Forsell teaches it is beneficial for an exit valve should be provided at the downstream end of the intestinal reservoir, which has to be closed while the reservoir is filling up, to prevent that intestinal contents may escape from the reservoir unintentionally (see Paragraph [0027]).
Regarding Claim 26, Lin teaches a system (ostomy pouching device for the removal of biological waste. see Abstract), comprising:
a bag device (see Figure 3) including an expandable reservoir (1), a first end of the expandable reservoir (base 110) configured to be connected to an end of an intestine via a first connector (bowel connector 300 connected to base 110, see Paragraph [0034]) so that intestinal contents flowing from the end of the intestine are received and collected within the expandable reservoir (see Paragraph [0034]), and a second end of the expandable reservoir (upper member 140) configured to be connected to an exit location via a second connector so that the intestinal contents collected within the expandable reservoir are to be drained to an exterior of a patient body (a second aperture to connect to an external connection 240 arranged to connect to a tube 410 through which the contents of inner bag 200 are removed, see Paragraph [0031]), the second connector including a control element movable between a closed configuration, in which contents of the reservoir are prevented from flowing there past (a cover 170 covers upper external tube 410 preventing flow, see Paragraph [0039]; Figure 10), and an open configuration, in which contents of the reservoir are permitted to flow there past to drain the expandable reservoir (such that when cover 170 is removed, the contents of inner bag 200 or container 100 may be removed, preferably by applying pressure onto container 100, see Paragraph [0039]).
However, Lin does not explicitly disclose a delivery device extending longitudinally and including a channel extending therethrough, the bag device insertable through the channel to a target location within a user body.
Forsell teaches a system is provided that acts on an intestinal reservoir (140, see Figure 1A) comprising: a delivery device extending longitudinally (laparoscopic surgical method comprising inserting at least one dissecting instrument preferably through a second trocar, dissecting an area of the intestine, see Paragraph [0114]) and including a channel extending therethrough (making a small opening in the patient’s skin and abdominal wall, see Paragraph [0114]), the bag device insertable through the channel to a target location within a user body (implanting at least a pump as part of a flow control device so as to permanently reside inside the patient’s body, see Paragraph [0114]).
Lin and Forsell are analogous art because both teach a system and method for treating a patient having a disorder related to the patient’s intestine.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the system of Lin and further include a delivery device extending longitudinally and including a channel extending therethrough, the bag device insertable through the channel to a target location within a user body, as taught by Forsell. Forsell teaches its beneficial to act on said intestinal wall so as to reduce the reservoir’s volume in order to empty intestinal contents from the reservoir to outside the patient’s body (see Paragraph [0114]).
Regarding Claim 27, Lin and Forsell teach all of the limitations as discussed above in claim 26 and Forsell further teaches a puncturing device configured to form an opening through a wall of the intestine (at least one dissecting instrument preferably through a second trocar, dissecting an area of the intestine, see Paragraph [0114]-[0121]) to which one of the first and second connectors of the bag device is to be engaged (implanting a pump device, see Paragraph [0123]).
Regarding Claim 28, Lin and Forsell teach all of the limitations as discussed above in claim 26 and Lin further teaches wherein the bag device includes a sensor positioned along the reservoir, the sensor configured to detect a fill level of the reservoir (device 1 may include one or more sensors to detect the fullness, pressure, and/or weight of the inner bag 200 or container 100, see Paragraph [0040]).
Regarding Claim 30, Lin and Forsell teach all of the limitations as discussed above in claim 26 and Forsell further teaches a system is provided that acts on an intestinal reservoir (140, see Figure 1A) having a second connector (non-modified terminate section 80) including a control element (valve section 61,62, and 63) wherein the control element includes one of a valve and an artificial sphincter (valves 61,62, and 63).
Regarding Claim 33, Lin teaches all of the limitations as discussed above in claim 31. However, Lin does not explicitly disclose wherein the exit location includes one of an anus and an opening extending through an abdominal wall of the user body.
Forsell teaches a laparoscopic surgical method wherein the exit location includes one of an anus and an opening extending through an abdominal wall of the user body (the system may be surgically connected to a surgically created stoma or to the patient’s rectum or anus or to tissue adjacent the patient’s anus, see Paragraph [0114]).
Lin and Forsell are analogous art because both teach a system and method for treating a patient having a disorder related to the patient’s intestine.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the exit location of Lin and further include wherein the exit location includes one of an anus and an opening extending through an abdominal wall of the user body, as taught by Forsell. Forsell teaches its beneficial to act on said intestinal wall so as to reduce the reservoir’s volume in order to empty intestinal contents from the reservoir to outside the patient’s body (see Paragraph [0114]).
Regarding Claim 35, Lin teaches all of the limitations as discussed above in claim 31. However, Lin does not explicitly disclose forming the opening through the wall at the end of the intestine via an electrocautery device.
Forsell teaches a laparoscopic surgical method forming the opening through the wall at the end of the intestine via an electrocautery device (inserting at least one dissecting instrument preferably through a second trocar, dissecting an area of the intestine, see Paragraph [0114]).
Lin and Forsell are analogous art because both teach a system and method for treating a patient having a disorder related to the patient’s intestine.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the method of treating an intestine of Lin and further include forming the opening through the wall at the end of the intestine via an electrocautery device, as taught by Forsell. Forsell teaches it is beneficial to act on said intestinal wall so as to reduce the reservoir’s volume in order to empty intestinal contents from the reservoir to outside the patient’s body (see Paragraph [0114]).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Lin and Forsell as applied to claim 26 above, and further in view of Scanlon (US 20070207186 A1).
Regarding Claim 29, Lin and Forsell teach all of the limitations as discussed above in claim 26. However, Lin and Forsell do not explicitly disclose wherein one of the first connector and the second connector includes a self-expanding mesh coil.
Scanlon teaches a more durable expanded material that enables thinner wall thicknesses and a more flexible reinforcement suitable for stenting. The present invention is especially useful in the construction of grafts, stents, and stent-grafts which are used in colostomy or ostomy procedures, see Paragraph [0161]) wherein one of the first connector and the second connector includes a self-expanding mesh coil (expanded material 12, see Figure 1).
Lin and Scanlon are analogous art because both teach an ostomy device having material configured to be implanted in the body.
It would have been obvious to a person having ordinary skill in the art before the effective filling date of the invention to modify the first or second connector of Modified Lin and further include wherein one of the first connector and the second connector includes a self-expanding mesh coil, as taught by Scanlon. Scanlon teaches it is beneficial for a reinforcement material suitable for stenting that has improved flexibility; a less complex manufacturing process; a wall thickness of varying thickness to reduce stress concentrations at the juncture between the stent and the passageway in which it is installed; and an ability to be easily produced in a large variety of sizes so that less stents are required by procedure (see Paragraph [0019]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIC RASSAVONG whose telephone number is (408)918-7549. The examiner can normally be reached Monday - Friday 9:00am-5:30pm PT.
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/ERIC RASSAVONG/ (8/3/2026)
Examiner, Art Unit 3781
/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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