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 amendments filed on 07/09/2026 has been entered. Claims 1, 4, 5, 11, and 12 have been amended; claims 10 and 14 have been cancelled. Accordingly, claims 1-9 and 11-13 are pending and under consideration.
Figures 1, 2, and 4 have been amended.
Applicant’s amendments to the claims and drawings have overcome each and every objection and 35. U.S.C. 112(b) rejection previously set forth in the Non-final Office action. Therefore, all drawing objections, and 35 U.S.C. 112(b) rejections are hereby withdrawn.
The amendment to the drawings has invoked new drawing objections. See objections of drawings below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any the same interpretation of the combination of references 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 hereby rejected under 35 U.S.C. 103 as being unpatentable over O’Toole et al. US 2008/0269700 A1 (previously cited), as cited in the IDS, in view of Tsal et al. US 2004/0059306 A1 (previously cited) and Hoggarth et al. US 2021/0100678 A1 (previously cited), as cited in the IDS, as necessitated by amendment.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: numerical character 116, 118 and 120. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over O’Toole et al. US 2008/0269700 A1 (previously cited, hereinafter O’Toole), as cited in the IDS, in view of Tsal et al. US 2004/0059306 A1 (previously cited, hereinafter Tsal) and Hoggarth et al. US 2021/0100678 A1 (previously cited, hereinafter Hoggarth), as cited in the IDS.
Regarding claim 1, O’Toole discloses an ostomy pouch 10” (Fig. 7 – ostomy pouch 10”) comprising:
a body side wall 14” (Fig. 7 – front side 14”) and a distal wall 16” (Fig. 7 – back side 16”) joined along their peripheral edges 18” (Fig. 7 – end 18”) to define a cavity 13” (Fig. 7 – interior 13”; Par. 44 discusses that the embodiment of Fig. 7 is generally similar to that of Fig. 1, thus the fundamental construct of the ostomy pouch and its numerical references are substantially similar) therebetween for collecting body waste (Par. 36 – “the first and second sides 14 and 16 are sealed or joined together at one end 18 so as to form an interior 13 for the collection of waste material”);
an inlet opening O (see annotated Fig. 7 below) defined in the body side wall 14” (Fig. 7) configured to receive a stoma (Fig. 7); and
a viewing window member 80 (Fig. 7 – layer 80) covering at least a portion of the distal wall 16” (Fig. 7), wherein the viewing window member 80 (Fig. 7) includes a viewing opening 90 (Fig. 7 – viewing window/cutout 90) having a first configuration (Fig.7 – the current configuration seen in Fig. 7), and
a curtain formed from an opaque material (Par. 45 – “sticker, decal, label, overlay or the like”) and configured to cover the viewing opening 90 (Fig. 7, and Par. 45 – “The ostomy pouches shown and/or described herein may also come with a sticker, decal, label, overlay or the like that is configured to be placed over the window once the pouch is in place”); and
a curtain securing member (Par. 45 – “sticker, decal, label, overlay or the like”, which inherently has an adhesive layer) comprising a first fastener disposed on the viewing window member 80 (Par. 45 – “The ostomy pouches shown and/or described herein may also come with a sticker, decal, label, overlay or the like that is configured to be placed over the window once the pouch is in place”; thus the surface of said window has to be compatible for the sticker, decal, label, etc., to stick to, thus indicating a fastener that is a compatible surface. Alternatively, the adhesive from the sticker or decal will transfer to the surface of window upon attachment, thus creating a first fastener), a second fastener disposed on the curtain (Par. 45 – “sticker, decal, label, overlay or the like”, which inherently has an adhesive layer) and wherein the first fastener and the second fastener are configured to engage with each other to hold the curtain in a closed position (Par. 45 – “The ostomy pouches shown and/or described herein may also come with a sticker, decal, label, overlay or the like that is configured to be placed over the window once the pouch is in place”).
However, O’Toole does not disclose a distal comfort panel joined to the distal wall; a viewing window member disposed intermediate the distal wall and the distal comfort panel, wherein the viewing window member is formed from an elastomeric material; wherein the viewing window member is configured to be stretched to increase a size of the viewing opening for viewing an interior of the ostomy pouch and recover the first configuration when released.
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Annotated Fig. 7 of O’Toole
Tsal, in the same field of endeavor of ostomy pouch (Par. 2), teaches a distal comfort panel 20 (Fig. 1-2 – front wall 20) joined to the distal wall 16 (Fig. 1 – front wall 16, and Abstract – “The inner pouch may be secured in position in the outer pouch by a separable adhesive coupling”).
Hoggarth, in the same field of endeavor of ostomy appliance (Title), teaches a viewing window member 6 (Fig. 2 – layer 6, Par. 213 – “The first part 6a and the second part 6b…. form a window opening for viewing the cavity”) formed from an elastomeric material (Par. 202 – “The film layer may comprise one or more of polyurethane, polyethylene (PE), polyvinylidene chloride (PVDC) and ethylene-vinyl acetate (EVA)”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the O’Toole further include a distal comfort panel as taught by Tsal, in order to provide a soft, comfortable surface on the exterior side (Par. 53 of Tsal). Since the device of O’Toole currently has the viewing window member on the outermost side, the incorporation of a distal comfort panel as taught by Tsal will have the viewing window member 80 of O’Toole in between the distal wall 16” of O’Toole and the incorporated distal comfort panel 20 of Tsal. Thus, the limitation “a viewing window member disposed intermediate the distal wall and the distal comfort panel” is met.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the viewing window member of the combination to have it form from an elastomeric material as taught by Hoggarth, in order to provide flexible sheets that increases the flexibility of use of the ostomy appliance (Par. 20 and Par. 105 of Hoggarth). Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the viewing window member of O’Toole out of an elastomeric material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Since one of ordinary skill in the art would have had the technological capability to recognize that an elastomeric has significant elastic deformation properties, the combined device would be capable of providing a viewing window member that can stretch to increase a size of the opening and recover to its original configuration when released. Thus, the limitation is “wherein the viewing window member is configured to be stretched to increase a size of the viewing opening for viewing an interior of the ostomy pouch and recover the first configuration when released” is read.
Regarding claim 2, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 1. The combination further discloses wherein at least a portion of the distal wall 16” (Fig. 7 of O’Toole) is formed from a transparent material (Fig. 7 of O’Toole, and Par. 44 of O’Toole – “In this embodiment, the back side 16'' is formed of a clear, transparent, translucent, semi-clear, semi-translucent or semi-transparent plastic”) and the viewing window member 80 (Fig. 7 of O’Toole) is formed f rom an opaque (Par. 44 of O’Toole – “The layer 80 may be an opaque, non-transparent or non-translucent,...”) elastomeric material (Par. 202 of Hoggarth).
Regarding claim 3, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 1. The combination further discloses wherein the viewing window member 80 (Fig. 7 of O’Toole) is formed from a thermoplastic elastomer (Par. 202 of Hoggarth).
Examiner notes that once the modification is made as discussed in claim 1, the viewing window member of O’Toole will be formed from an elastomeric material as taught by Hoggarth, such as EVA which is a thermoplastic elastomer. Thus, the limitation is read.
Regarding claim 4, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 1. The combination further discloses wherein the distal comfort panel 20 (Fig. 1-2 of Tsal) is formed from an opaque material (Par. 53 of Tsal – “The front wall 20… of the outer pouch 14 may also include a comfort layer on the exterior surface, to provide a soft, comfortable cloth-like surface”) and includes a first opening 35 (Fig. 2 of Tsal – access window 35) and wherein the viewing window member 80 (Fig. 7 of O’Toole) is arranged such that the viewing opening 90 (Fig. 7 of O’Toole) is arranged within the first opening 35 (Fig. 2 of Tsal).
Once the modification is made as discussed in claim 1, since the device of O’Toole currently has the viewing window member on the outermost side, the incorporation of a distal comfort panel as taught by Tsal will have the viewing window member in between the distal wall and the distal comfort panel. Moreover, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have disposed the distal comfort panel with its opening align with the viewing opening so that observation is made accessible, and since Tsal favors a larger size for window 35 compared to the inner member (Par. 37 of Tsal). Thus, the limitation of “wherein the viewing window member is arranged such that the viewing opening is arranged within the first opening” is met.
Regarding claim 5, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 4. The combination further discloses wherein the viewing opening 90 (Fig. 7 of O’Toole) having a diameter smaller than a diameter of the first opening 35 (Fig. 2 of Tsal; Examiner notes that once the modification is made as discussed in claim 4, the opening 35 of Tsal will be larger than its inner member, in this instant case, the opening of the viewing window member 80 of O’Toole, such that the viewing opening is arranged within the first opening), wherein the viewing window member 80 (Fig. 7 of O’Toole) is configured to be stretched in various directions to increase the size of the viewing opening 90 (Fig. 7 of O’Toole) and return to the first configuration when released (Par. 202 of Hoggarth and as discussed in claim 1, the elastomeric material as taught by Hoggarth will allow elastic deformation of the viewing window member).
However, the combination does not currently disclose wherein the viewing opening is a circular opening.
O’Toole, in another embodiment, teaches that wherein the viewing opening 42 (Fig. 2A – portion 42) is a circular opening (Fig. 2A).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the viewing opening of the combination to have a circular opening, also as taught by O’Toole, as O’Toole teaches both embodiments. The rationale to support a conclusion that the claim would have been obvious is that all 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.). Furthermore, 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 viewing opening of the combination to be circular, as it is a matter of engineering design, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Regarding claim 6, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 4. The combination further discloses wherein the viewing opening 90 (Fig. 7 of O’Toole) extending across the viewing window member 80 (Fig. 7 of O’Toole), wherein the viewing window member 80 (Fig. 7 of O’Toole) is configured to be stretched and separated at the opening 90 (Fig. 7 of O’Toole; Par. 202 of Hoggarth and as discussed in claim 1, the elastomeric material as taught by Hoggarth will allow elastic deformation of the viewing window member)) to provide a viewing window 90 (Fig. 7 of O’Toole) and return to the first configuration when released (Par. 202 of Hoggarth and as discussed in claim 1).
However, the combination does not disclose wherein the viewing opening comprises a slit-like opening.
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 viewing opening of the combination to be a slit-like opening, as it is a matter of engineering design, where the change in form or shape, without any new or unexpected result, is an obvious engineering design. See In re Dailey, 149 USPQ 47 (CCPA 1966) (see MPEP § 2144.04).
Regarding claim 7, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 6. The combination further discloses wherein the slit-like opening 90 (Fig. 7 of O’Toole upon modification as discussed in claim 6) is formed from a cut (Par. 44 of O’Toole – “The layer 80 has a viewing window, area or cutout 90“) extending across at least a portion of the viewing window member 80 (Fig. 7 of O’Toole).
Regarding claim 8, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 4. The combination further discloses wherein the viewing window member 80 (Fig. 7 of O’Toole) is arranged between the distal wall 16” (Fig. 7 of O’Toole) and the distal comfort panel 20 (Fig. 2 of Tsal), wherein the viewing window member 80 (Fig. 7 of O’Toole) is sealed to the distal comfort panel 20 (Fig. 2 of Tsal).
Examiner notes that once the modification is made as discussed in claim 4, the incorporation of a distal comfort panel as taught by Tsal will have the viewing window member in between the distal wall and the distal comfort panel since the device of O’Toole currently has the viewing window member on the outermost side.
Regarding claim 9, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 4. The combination further discloses wherein the viewing window member 80 (Fig. 7 of O’Toole) is arranged between the distal wall 16” (Fig. 7 of O’Toole) and the distal comfort panel 20 (Fig. 2 of Tsal), wherein the viewing window member 80 (Fig. 7 of O’Toole) is sealed to the distal wall 16” (Fig. 7 of O’Toole).
Examiner notes that once the modification is made as discussed in claim 4, the incorporation of a distal comfort panel as taught by Tsal will have the viewing window member in between the distal wall and the distal comfort panel since the device of O’Toole currently has the viewing window member on the outermost side.
Regarding claim 11, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 1. The combination further discloses wherein the curtain (Par. 45 of O’Toole – sticker, decal, etc.) includes a first portion attached to the viewing window member 80 (Par. 45 of O’Toole – “The ostomy pouches shown and/or described herein may also come with a sticker, decal, label, overlay or the like that is configured to be placed over the window once the pouch is in place”, thus indicating a portion of the sticker or decal that attaches to the window)
However, the combination does not disclose a second unattached portion, wherein the curtain is configured to be opened by lifting up the second unattached portion to provide an access to the viewing opening.
Tsal, in the same field of endeavor of ostomy pouch (Par. 2), teaches a second unattached portion 36 (Fig. 2 – top fastener 36 is shown to be unattached), wherein the curtain 34 (Fig. 2 – openable portion 34) is configured to be opened by lifting up the second unattached portion 36 (Fig. 2) to provide an access to the viewing opening 35 (Fig. 2 – access window 35, and Par. 40 – “the second fastener 36 is unfastened to release the openable portion 34”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the curtain of the combination to further have an unattached portion as taught by Tsal, in order to form a door or flap to define an access window (Par. 37 of Tsal). Said door or flap provides access to the interior of the device.
Regarding claim 12, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 10. However, the combination does not disclose wherein the curtain is integrally formed with the distal comfort panel.
Tsal, in the same field of endeavor of ostomy pouch (Par. 2), teaches wherein the curtain 34 (Fig. 1-2 – openable portion 34) is integrally formed with the distal comfort panel 20 (Fig. 1-2 – front wall 20, and Par. 37 – “an openable portion 34 of the front wall 20 may be provided, in the form of a door, flap or hatch portion”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the curtain of the combination such that it is an integral part of a distal comfort panel positioned on the distalmost side of ostomy pouch as taught by Tsal, in order to define an access window (Par. 37 of Tsal) and provide easy access to the inner component (Par. 37 of Tsal). Furthermore, 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 curtain integral to the distal comfort panel, 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).
Regarding claim 13, O’Toole in view of Tsal in view of Hoggarth suggests the invention of claim 12. The combination further discloses wherein the curtain 34 (Fig. 2 of Tsal) is formed from a punched-out section 34 (Fig. 2 of Tsal) of the distal comfort panel 20 (Fig. 2 of Tsal – portion 34 is carved out from wall 20), wherein a first portion 36 (Fig. 2 of Tsal – bottom fastener 36) of the punched-out section 34 (Fig. 2 of Tsal) remains connected to the comfort panel 20 (Fig. 2 of Tsal – the bottom fastener 36 remains fastened) while a second portion 36 (Fig. 2 of Tsal – top fastener 36) of the punched-out section 34 (Fig. 2 of Tsal) is unattached from the distal comfort panel 20 (Fig. 2 of Tsal – the top fastener 36 is unfastened), and wherein the curtain 34 (Fig. 2 of Tsal) is configured to be opened by moving the second portion 36 (Fig. 2 of Tsal – top fastener 36, and Par. 41 of Tsal – “the second fastener 36 is unfastened to release the openable portion 34 of the front wall 20”).
Examiner notes that once the modification is made as discussed in claim 12, the curtain of distal comfort panel of Tsal is incorporated into the device of the combination, including the attached and unattached portion of the curtain.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Marshall US 2014/0207093 A1 teaches a sleeve flap that allows the interior bag to be visible for monitoring.
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.
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
