DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/03/2025 has been entered.
Response to Amendment
The amendments filed on 10/03/2025 has been entered. Claim 1 has been amended; claims 12 and 19 have been cancelled. Accordingly, claims 1-11, 13-18, and 20 are pending and under consideration.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In light of further search and consideration, claim 1 is rejected, necessitated by amendment, under 35 U.S.C. 103 as being unpatentable over Sawers et al. US 5,834,009 A (newly cited). See rejection of claims below.
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 1-11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sawers et al. US 5,834,009 A (newly cited, hereinafter Sawers).
Regarding claim 1, Sawers discloses an ostomy appliance 10’ (Fig. 4 – ostomy appliance 10’) including:
first 11b’ (Fig. 5 – side wall 11b) and second walls 11a’ (Fig. 4, and Fig. 2 for exemplary demonstration of the side wall 11a since the ostomy appliance 10’ also comprises pouch 11’ that is similar in construction to the pouch of Fig. 2, as discussed in Col. 4, line 49-51) which are connected at or near their peripheries 13’ (Fig. 4 – edges 13’) to provide a waste collecting cavity 11’ (Fig. 4 – pouch 11’) therebetween;
a stoma-receiving opening (see annotated Fig. 5 below) provided in the first wall 11b (see annotated Fig. 5 below); and
a connection member 12’ (Fig. 4 and Fig. 5 – wafer 12’) having one or more slits 30 (Fig. 4-6 – depressions 30) that extend radially outwards relative to the stoma-receiving opening (see annotated Fig. 5 below – depressions are arranged radially and outwardly from the annotated stoma-receiving opening of the first wall 11b), wherein the connection member 12’ (Fig. 5) has an adhesive side 14’ (Fig. 5 – adhesive layer 14’) for connection to a patient around a stoma (Col. 5, line 7-9 – “The ridges 31 are flat-topped for adhesively contacting and sealingly engaging a skin surface surrounding a stoma”; since the ridges 31 are a part of the adhesive layer 14’, this layer 14’ is intended for the attaching to the patient) and a connection side 15’ (Fig. 5 – the layer to the left of layer 14’, and Col. 4, line 61-64 – “Wafer 12' is non-circular in outline and includes adhesive layer 14' and backing layer 15' having compositions similar to those already described”; see Fig. 2 for exemplary demonstration) opposite the adhesive side 14’ (Fig. 5 – backing layer 15’ is opposite the adhesive layer 14’), wherein the connection side 15’ (Fig. 5) is attached to an exterior surface of the first wall 11b’ (Fig. 5 – backing layer 15’ is disposed on the exterior of side wall 11b’; see Fig. 2 for exemplary demonstration) by a connection arrangement 20’ (Fig. 5 – annular heat seals 20’) that is external of the waste collecting cavity 11’ (Fig. 5 – heat seals 20’ are disposed on the exterior of pouch 11’), and wherein the connection arrangement 20’ (Fig. 5) includes:
a first connection formation F1 (see annotated Fig. 5 below – innermost annular heat seal 20’, also annotated as first formation connection F1) external of the waste collecting cavity 11’ (see annotated Fig. 5 below – first connection formation F1 is disposed on the exterior of pouch 11’) and extending around the stoma-receiving opening (see annotated Fig. 5 below) and has a periphery (see annotated Fig. 5 below) and provides support between the connection member 12’ (Fig. 5) and the first wall 11b’ (Col. 3, line 45-48 – “The backing layer 15 is permanently joined to wall 11b of the pouch by one or more annular heat seals 20 surrounding the stoma-receiving opening 17”); and
a second connection formation F2 (see annotated Fig. 5 below – outer annular heat seal 20’, also annotated as second formation connection F2) external of the waste collecting cavity 11’ (see annotated Fig. 5 below – second connection formation F2 is disposed on the exterior of pouch 11’) and disposed outside of the periphery of the first connection formation F1 (see annotated Fig. 5 below – second formation connection F2 is radially outside the annotated periphery of first connection formation F1) and further away from the stoma-receiving opening (see annotated Fig. 5 below) than the first connection formation F1 (see annotated Fig. 5 below – F2 formation is further away from the annotated stoma-receiving opening),
wherein the second connection formation F2 (see annotated Fig. 5 below) extends above the periphery of the first connection formation F1 (see annotated Fig. 5 below) and between the one or more slits 30 (see annotated Fig. 5 below – second formation F2 is disposed above the annotated periphery and between the depressions 30), and wherein the connection arrangement is provided by welding (Col. 3, line 47 – “heat seals”) between the connection member 12’ (Fig. 5) and the exterior surface of the first wall 11b’ (Fig. 5).
However, Sawers does not currently disclose wherein the second connection formation is disposed at a radial distance from the stoma-receiving opening that is the same or larger than a radial distance between the stoma-receiving opening and an innermost end of the one or more slits.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the radial distance of the second connection formation from the opening to be the same or larger than a radial distance between the opening and an innermost end of the slits, in order to fit the particular procedure being done since this claimed the second connection formation does not change the connection member ability to attach to the exterior surface of the ostomy wall. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 41 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
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Annotated Fig. 5 of Sawers
Regarding claim 2, Sawers discloses the invention of claim 1. Sawers further discloses wherein the second connection formation F2 (see annotated Fig. 5 above) is positioned, in use, above the stoma-receiving opening (see annotated Fig. 5 above – formation F2 is above the annotated opening at the top).
Regarding claim 3, Sawers discloses the invention of claim 1. Sawers further discloses wherein the second connection formation F2 (see annotated Fig. 5 above) is discrete from the first connection formation F1 (see annotated Fig. 5 above – F1 formation is distinct and discrete from F2 formation).
Regarding claim 4, Sawers discloses the invention of claim 3. Sawers further discloses wherein the second connection formation F2 (see annotated Fig. 5 above) is substantially circular (Fig. 5 – heat seals 20, including second connection formation F2, are annular/circular).
Regarding claim 5, Sawers discloses the invention of claim 1. However, Sawers does not disclose wherein the second connection formation is connected to the first connection formation.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the second and first connection formation of Sawers connected, since such modification would have involved making elements integral. Making elements integral is generally recognized as being within the level of ordinary skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Once the modification is made as discussed, the annotated periphery of first connection formation F1 would meet the adjacent periphery of second connection formation F2.
Regarding claim 6, Sawers discloses the invention of claim 5. Sawers further discloses wherein the second connection formation F2 (see annotated Fig. 5 above) extends generally towards the stoma-receiving opening (see annotated Fig. 5 above – the annular seal 20/second connection formation F2 surrounds the annotated stoma-receiving opening) and connects to the periphery (see annotated Fig. 5 above) of the first connection formation F1 (see annotated Fig. 5 above).
Once the modification is made as discussed in claim 5, the periphery of F1 formation would meet the adjacent periphery of the F2 formation. Thus, the limitation is met.
Regarding claim 7, Sawers discloses the invention of claim 5. Sawers further discloses wherein the second connection formation F2 (see annotated Fig. 5 above) includes a curved end portion positioned distally from the first connection formation F1 (see annotated Fig. 5 above; Examiner notes that since F2 formation is annular/circular, it indeed has a curvature on the outermost edge that is positioned away from the F1 formation).
Regarding claim 8, Sawers discloses the invention of claim 1. Sawers further discloses wherein an attachment zone 20’ (Fig. 5) of the second connection formation F2 (see annotated Fig. 5 above) extends to a position which is spaced from an edge of the connection member 12’ (see annotated Fig. 5 above; F2 formation would extend to a position that is some distance away from the edge of the wafer 12’, see Fig. 2 for an exemplary demonstration).
Regarding claim 9, Sawers discloses the invention of claim 1. Sawers further discloses wherein there is a plurality of second connection formations F2 (see annotated Fig. 5’ below – there are two outer annular heat seals 20/second connection formations F2).
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Annotated Fig. 5’ of Sawers
Regarding claim 10, Sawers discloses the invention of claim 9. Sawers further discloses wherein each of the second connection formations F2 (see annotated Fig. 5’ above) is discrete from the first connection formation F1 (see annotated Fig. 5’ above – two outer second formation connections F2 are both and distinct discrete from the first formation connection F1).
Regarding claim 11, Sawers discloses the invention of claim 9. Sawers further discloses wherein there are between two and five second connection formations F2 (see annotated Fig. 5’ above – two annular heat seals 20/second formation connections F2), which are spaced apart from each other (see annotated Fig. 5’ above – each of the second formation connection F2 is distanced from each other).
Regarding claim 13, Sawers discloses the invention of claim 1. Sawers further discloses wherein the one or more slits 30 (Fig. 4) comprises a pair of slits (see annotated Fig. 4 below – the top two depressions 30) which are spaced apart and angled away from each other above the stoma-receiving opening (see annotated Fig. 5 above and Fig. 4 below – the pair of slits are spaced apart and angled away from each other while being above the stoma-receiving opening), towards an upper part of the first wall 11b’ (see annotated Fig. 4 below and Fig. 5 – the annotated pair of slits are disposed at the top of side wall 11b’).
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Annotated Fig. 4 of Sawers
Regarding claim 14, Sawers discloses the invention of claim 1. Sawers further discloses wherein each of the one or more slits 30 (Fig. 4) has a radially innermost end (see annotated Fig. 4 above) which is spaced at a radial distance from a centre of the stoma-receiving opening (see annotated Fig. 5 above and Fig. 4 above) and the periphery of the first connection formation F1 (see annotated Fig. 5” below) is disposed at a smaller radial distance from the centre of the stoma-receiving opening (see annotated Fig. 5” below).
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Annotated Fig. 5” of Sawers
Regarding claim 15, Sawers discloses the invention of claim 1. Sawers further discloses wherein the first connection formation F1 (see annotated Fig. 5 above) extends completely around the stoma-receiving opening (see annotated Fig. 5 above; the heat seals 20, including the first connection formation F1, is annular, thus extends around the stoma-receiving opening).
Regarding claim 16, Sawers discloses the invention of claim 14. Sawers further discloses wherein the first connection formation F1 (see annotated Fig. 5 above) has a second, inner, periphery (see annotated Fig. 5 above) which is coincident with the stoma-receiving opening (see annotated Fig. 5 above – the annotated second inner periphery of F1 formation is coincident with the stoma-receiving opening).
Regarding claim 17, Sawers discloses the invention of claim 1. Sawers further discloses wherein a midline 5-5 (Fig. 4 – line 5-5) which, in use, extends substantially vertically through the stoma-receiving opening (Fig. 4 – line 5-5 extends vertically through the stoma-receiving opening).
However, Sawers does not disclose wherein the first connection formation is substantially symmetrical about a midline.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have made the first connection formation be substantially symmetrical about a midline, in order to fit the particular procedure being done since this claimed dimension of the first connection formation does not change the connection member ability to attach to the exterior surface of the ostomy wall. Since applicant has not given any criticality to why the dimension disclosed has any importance to the function of the claimed device (Par. 17 of Applicant’s specification), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777.
Regarding claim 18, Sawers discloses the invention of claim 1. Sawers further discloses wherein the first connection formation F1 (see annotated Fig. 5 above) is substantially circular or annular (Col. 3, line 47-48 – “one or more annular heat seals 20 surrounding the stoma-receiving opening 17”).
Regarding claim 20, Sawers discloses the invention of claim 1. Sawers further discloses wherein the second connection formation F2 (see annotated Fig. 5 above) provides a direct connection between the first wall 11b’ (Fig. 5) and the connection member 12’ (Fig. 5).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kuczynski US 5,722,965 A
Cramer et al. US 2011/0213322 A1
Lam et al. US 2018/0263805 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH DAO LE whose telephone number is (571)272-7198. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781