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 § 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.
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.
Claims 1-6, 9-13, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kjeldsen WO 2016/019963.
As to claim 1, Kjeldsen teaches a waste collection system for collecting waste from a body of a patient, the waste collection system comprising:
an endoluminal stoma channel comprising a resilient deformable inner (first) ring 3, an outer (second) ring 4, a flexible polymer sleeve 5 comprising a biocompatible polymer and interconnecting the inner ring 4 and the outer ring 3 (Fig. 1; page 3, lines 1-10; page 4, line 28 through page 5, line 6; page 7, lines 1-5);
an inner colostomy bag 2 (Fig. 1; page 2, line 30). Kjeldsen does not teach the inner colostomy bag 2 is configured to be detachably attached to the outer ring 4. Rather, Kjeldsen teaches the inner ring 3 and outer ring 4, are connected by an interspace piece 5 of a thin, flexible and elastic material. Kjeldsen teaches said material continues beyond the second ring 4 and forms the collection bag 2 (page 7, lines 1-5). Kjeldsen suggests the inner colostomy bag 2 is formed integrally with the inner and outer rings and interspace piece 5 (page 2, lines 18-20) as opposed to being detachably attached to the outer ring 4. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Kjeldsen to have a detachable colostomy bag since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
Kjeldsen teaches the wherein the inner colostomy bag comprises an elastic polymer membrane - where Kjeldsen teaches interspace piece 5 comprises and thin, flexible and elastic material, preferably Latex (page 7, lines 2 and 24-28); and Kjeldsen further teaches the collection bag is made of the same material as the interspace piece (page 3, line21). Kjeldsen does not specifically teach the material has an elongation of at least about 100% without breaking. It is old and well known that latex materials have very high elongation at break, often in the range of 700-1000%. This means the material can stretch to 1-10 times its original length before breaking. For example, Thiyagarajan et al. US Patent Application Publication 2021/0189106 teaches elastomeric latex articles, such as gloves and condoms (Abstract) exhibiting an elongation at break of about 1,100% or greater (para. 0005).
Kjeldsen further teaches the waste collect system comprises a cover 30 comprising a clamp or seal element configured to engage the outer ring in a sealed engagement with the inner colostomy bag attached to the outer ring (page 10, lines 12-18),
wherein a portion of the flexible polymer sleeve and the inner ring are configured for insertion into a stoma formed in the body of the patient (Fig. 2; page 3, lines 1-10)
As to claim 2, the inner colostomy bag is biodegradable – where Kjeldsen teaches all or parts of the material of the ostomy bag may be biodegradable (page 4, lines 1-2).
As to claim 3, the waste collection system of claim 1 wherein the inner colostomy bag 2 comprises latex – Kjeldsen teaches with regard to the interspace piece, choice of material and thickness may be varied until sufficient elasticity and pressure are accomplished, one preferred material could be latex (page 7, lines 16-18 and 27-28). Kjeldsen further teaches the collection bag is made of the same material as the interspace piece (page 3, line 21)
As to claim 4, the waste collection system of claim 1 wherein the inner colostomy bag 2 comprises a colostomy ring 3 positioned at a mouth of the inner colostomy bag 2 and configured to sealingly engage the outer ring 4 of the endoluminal stoma channel, wherein the colostomy ring is resilient and deformable – where Kjeldsen teaches the rigidity and thickness of the ring as such are adapted to be compressed so it can easily be inserted into the stoma 23 (Fig 2; page 7, lines 13-15).
As to claim 5, the waste collection system of claim 1 wherein the colostomy ring comprises a tab positioned on the periphery of the colostomy ring – where Kjeldsen teaches the entire ostomy bag are removed easily by a skew pull in the second ring 4 (Fig. 2 ;page 7, lines 20-22).
As to claim 6, the outer ring comprises a non- circular cross section - where Kjeldsen teaches the first 3 and second 4 rings are not necessarily circular in the rings’ own cross sections, and they may be oval or have another suitable shape (page 7, lines 7-8).
Kjeldsen teaches lid 30 and that if the lid 30 falls of the outer (second ring) 4, the collection bag 2 will unfold and operate as usual (page 10, lines 16-18). Based on this disclosure, it is reasonable to conclude the outer ring 4 is capable of being folded over the collection bag (flexible polymer sleeve) 2.
As to claim 9, Kjeldsen does not specifically teach the inner colostomy bag is detachably attached to the outer ring 4 by a snap-on mechanism or a slip-on mechanism. However, Kjeldsen does teach following insertion of the first ring 3 and optionally adjustment of the second ring 4 via ribs 7 (Figs. 4a-4c; page 9, lines 4-10). Kjeldsen further teaches the collection bag 2 is pushed into the insertion part 1, or merely towards it, and the lid 30 is clicked onto the second ring 4 (page 10, lines 8-13). The lid 30 helps to secure the ostomy bag and provide a complete enclosure for feces.
As to claim 10, the inner colostomy bag 2 and/or the cover further comprises a gas releasing mechanism configured to be detachably attached to inner colostomy bag 2 (page 3, lines 23-24).
As to claim 11, the gas releasing mechanism comprises an air release tube – where teaches a degassing valve provided with a filter (Fig. 7; page 3, lines 26-28).
As to claim 12, the waste collection of claim 1 further comprising an introducer 12 (insertion tool) configured to insert the inner ring 3 and portion of the flexible polymer sleeve 5 into the stoma (Fig. 6; page 10, lines 20-30).
As to claim 13, Kjeldsen does not teach an introducer and a pusher device. Kjeldsen teaches the insertion tool 12 is a stick with a u-shaped retention part at the one end configured for being positioned on the first ring 3. Kjeldsen further teaches a slight pull in the interspace piece 5 (flexible polymer sleeve) will deform the first ring 3, and stay in contact with the engagement of the stick 12 with the first ring 3, which can then be inserted into the stoma 23 (Fig. 6; page 10, lines 20-30). While Kjeldsen does not teach a separate tubular introducer and a pusher device, Kjeldsen does teach an integral stick 12 with a u-shaped retention portion that performs the same function as inserting the inner ring 3 into the stoma opening. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Kjeldsen to have an introducer and a pusher device since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 179.
As to claim 21, Kjeldsen teaches a method for collecting waste a stoma through an endoluminal stoma channel comprising:
a resilient deformable inner ring 3,
an outer ring 4, and a
flexible polymer sleeve 5 connected to the inner ring 3 and the outer ring 4 to form a flow channel and comprising a biocompatible polymer (Fig. 1; page 3, lines 1-10; page 4, line 28 through page 5, line 6; page 5, lines 24-26; page 7, lines 1-5),
the method comprising:
engaging and inner colostomy bag 2 onto the outer ring and positioning the inner colostomy bag in the inner aspect of the flexible polymer sleeve 5 – where Kjeldsen teaches the inner colostomy bag 2 is inserted into the insertion part, which includes outer ring 4, using an insertion tool 12 (Fig. 6; page 10, lines 20-30);
Kjeldsen teaches the wherein the inner colostomy bag comprises an elastic polymer membrane - where Kjeldsen teaches interspace piece 5 comprises and thin, flexible and elastic material, preferably Latex (page 7, lines 2 and 24-28); and Kjeldsen further teaches the collection bag is made of the same material as the interspace piece (page 3, line 21). Kjeldsen does not specifically teach the material has an elongation of at least about 100% without breaking. It is old and well known that latex materials have very high elongation at break, often in the range of 700-1000%. This means the material can stretch to 1-10 times its original length before breaking. For example, Thiyagarajan et al. US Patent Application Publication 2021/0189106 teaches elastomeric latex articles, such as gloves and condoms (Abstract) exhibiting an elongation at break of about 1,100% or greater (para. 0005).
The method further comprises:
engaging a cover with a clamp onto the outer ring of the endoluminal stoma channel - where Kjeldsen further teaches the waste collect system comprises a cover 30 comprising a clamp or seal element configured to engage the outer ring in a sealed engagement with the inner colostomy bag attached to the outer ring (page 10, lines 12-18),
wherein the inner ring 3 is located within the patient with the flexible polymer sleeve 5 extending outward from the stoma with the outer ring 4 positioned outside the stoma (Figs. 1 and 2; page 3, lines 1-10)),
wherein the inner colostomy bag 2 and cover 30 provides closure of the stoma or a controlled pathway for releases from the stoma - where Kjeldsen teaches that by clicking the lid 30, the ostomy bag converted into a complete enclosure for feces (page 10 lines 15-16; Fig. 7); and
disengaging the cover 30 from the outer ring 4 allowing waste from stoma to be collected within the inner colostomy bag – where Kjeldsen teaches if the lid 30 falls off, the second ring 4, the collection bag 2 will unfold and operate as usual (page 10 lines 16-18; Fig. 7).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kjeldsen WO 2016/019963 in view of Nielsen WO 2014/177723.
As to claim 7, Kjeldsen teaches the present invention substantially as claimed. Kjeldsen does not teach the inner ring comprises circumferential protrusions. Nielsen teaches a device 500 for directing output from a stoma with a moveable portion 521 ring that comprises rings 522, 523 that have circumferential protrusions (arms with teeth 524, 526) (Figs. 9a, 9b; page 20, lines 1-24). Nielsen teaches the benefit of the teeth 526 is to allow the movable portion 521 to only move inwards and avoids any outwards movement of the moveable portion 521. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the inner ring of Kjeldsen with circumferential protrusions for the benefits taught in Nielsen.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kjeldsen WO 2016/019963 in view of Smith et al. USPN 8740832.
As to claim 8, Kjeldsen teaches the present invention substantially as claimed. Kjeldsen does not teach the flexible polymer sleeve is transparent. Smith teaches the outer bag 6 can be formed from materials well known for the construction of ostomy bag, including from a tough, flexible transparent, waterproof material (Smith col. 6, lines 15-18). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify Kjeldsen with a transparent waterproof material since Smith teaches these materials for ostomy bags since the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art (MPEP 2143.A.). Kjeldsen further teaches the collection bag is made of the same material as the interspace piece (page 3, line 21).
Claims 14, 15, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kjeldsen WO 2016/019963 in view of Nielsen WO 2014/177723 and further in view of Neumeier USPN 4004589.
As to claim 14, Kjeldsen teaches an endoluminal stoma channel comprising:
an inner ring 3 that is resilient and deformable – where Kjeldsen teaches the insertion part comprises and first ring and a second ring and a physically deformable interspace piece (page 2, line 31 through page 3, line 1; page 7, lines 1-3).
Kjeldsen teaches the present invention substantially as claimed. Kjeldsen does not teach the outer surface of the inner ring comprises contours and/or texture. Nielsen teaches a device 500 for directing output from a stoma with a moveable portion 521 ring that comprises rings 522, 523 that have circumferential protrusions (arms with teeth 524, 526) (Figs. 9a, 9b; page 20, lines 1-24). Nielsen teaches the benefit of the teeth 526 is to allow the movable portion 521 to only move inwards and avoids any outwards movement of the moveable portion 521. It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the inner ring of Kjeldsen with contours and/or texture for the benefits taught in Nielsen.
Kjeldsen/Nielsen do not teach the inner ring having a shore durometer value of no more than 65A. Neumeier teaches an ostomy appliance made of natural or synthetic rubber, silicon rubber, or other suitable material. Neumeier teaches advisably the nozzle should be made of a material which has a 40 to 90A Shore durometer range so that the desired softness and flexibility is achieved (Neumeier col. 3, lines 37-42). It would have been obvious for one having ordinary skill in the art before the invention was originally filed to modify the insertion portion of Kjeldsen/Nielsen with a rubber material (Latex) having a Shore durometer within the claimed range of no more than 65A, since Neumeier teaches the desired softness and flexibility can be found with the range of 40 to 90A.
Kjeldsen/Nielsen/Neumeier further teaches an outer ring 4; and
a flexible polymer sleeve 2 connected to the inner ring and the outer ring to form a flow channel and comprising a biocompatible polymer – where Kjeldsen teaches all or parts of the material of the ostomy plug may be biodegradable (Kjeldsen page 5, line 21).
As to claim 15, see the rejection of claim 14 supra. Kjeldsen teaches the insertion portion comprises the first (inner) ring 3 and second (outer) ring 4 (Kjeldsen page 2, line 31 through page 3, line 1; page 7, lines 1-3).
As to claim 17, Kjeldsen/Nielsen/Neumeier teach the outer surface comprises contours having one or more concave, ogee, French curve, arch, or hook regions - where Nielsen teaches the elastic element is in the form of a tubular element where both ends have been rolled up (Nielsen Fig. 14; page 22, line 38 through page 23, line 5). Nielsen teaches the rolled up portions will make the ends easier to manipulate and in certain cases provide an extra sealing effect due to the extra stiffness and/or due to the “edge” which the rolled up portion creates (Nielsen page 23, line 1-9). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the outer surface of the inner ring of Kjeldsen with one or more concave, ogee, French curve, arch or hook regions for the benefits taught in Nielsen.
As to claim 18, Kjeldsen/Nielsen/Neumeier teach the outer surface is textured having one or more nubs, bumps, ribs, or protrusions - Nielsen Figs. 9A, 9B. See the rejection of claim 7 supra.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kjeldsen WO 2016/019963 in view of Nielsen WO 2014/177723 and further in view of Neumeier USPN 4004589 and further in view of Bonadio US Patent Application Publication 2014/0303443.
As to claim 16, Kjeldsen/Nielsen/Neumeier teach the present invention substantially as claimed. Kjeldsen/Nielsen/Neumeier do not teach the endoluminal stoma channel of claim 14 further comprising a tether comprising a cord and a knob, wherein cord is attached to the inner ring, and the knob has a position such that the cord can extend along the sleeve, in the interior or adjacent the exterior of the sleeve, past the outer ring with the outer ring pulled away from the inner ring such that the sleeve is taut. Bonadio teaches an incision 6 capable of being used as an endoluminal stoma channel 6 (Figs. 1, 3; paras.0118, ) having a tether comprising a cord 81 and a knob 83 – where Bonadio teaches when it is desired to remove the wound retractor 1 from the opening 6, the bead 83 is detached from the outer ring 4 (proximal member) and pulled upwardly to draw the ribbon (cord) 81 taut (Fig. 3; para. 0140). The tie 84 can be grabbed by the fingertips when the surgeon is ready to take the distal ring 3 out (para. 0140). It would have been obvious to one having ordinary skill in the art before the invention was originally filed to modify the invention of Kjeldsen/Nielsen/Neumeier to provide a tether as taught in Bonadio to allow easy removal of the ostomy appliance after use.
Kjeldsen/Nielsen/Neumeier/Bonadio show the cord 81 is attached to the inner ring 3, and the knob 83 has a position such that the cord 81 can extend along the sleeve 2 (Fig. 4), in the interior or adjacent the exterior of the sleeve 2 (Figs 1 and 4), past the outer ring 4, with the outer ring pulled away from the inner ring such that the sleeve is taut (Figs. 3 and 4; para. 0140).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Turner US 2008/0065031 is cited to show an ostomy appliance with a tether and Blumrosen et al. US 2020/0093633 is cited to show an ostomy appliance with a contoured outer surface.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781
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