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 .
Status of Claims
As directed by the amendment filed on 16 March 2026: claim(s) 1-3, 6, 8-9, and 21-22 have been amended, claim(s) 7 and 10 have been cancelled.
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.
Claim(s) 1-4, 6, 8-9, 11-12, 14-16, 18-19, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray (US 20110028924 A1) in view of Jones et al. (US 20180333290 A1).
Regarding Claim 1, Murray discloses an ostomy pouch ("ostomy pouch 10" [0028]; FIGs. 1-5), comprising:
inner and outer walls of flexible sheet material defining a cavity for containing a stomal output ("front wall 12 and a rear wall 14 of flexible impermeable plastics film" [0028]);
a deployable drain for draining stomal output from the cavity ("outlet 22 in the form of a drain chute portion 24 of the pouch 10" [0031]);
at least one sheet of comfort material ("comfort layer 30" [0048]);
wherein the deployable drain is moveable between an extended configuration for draining the stomal output from the cavity (FIG. 2) and a retracted configuration for storage of the deployable drain ("drain chute portion 24 is folded upwardly four times to its closed configuration" [0041]);
wherein the at least one sheet of comfort material is attached to the outer wall, at least a portion of the first sheet of comfort material forming a flap ("comfort layer 30 on the flaps 41, 42 is an extension of the comfort layer 30 on the respective pouch wall 12, 14" [0048]; FIG. 2);
the flap configured to fold along a fold line ("attached at points 54, 56" [0049]; FIG. 2), between a covering position in which the flap covers the deployable drain when the deployable drain is in the retracted configuration ("flap fastener 44 is fastened by pressing the flaps 41, 42 together, as illustrated by arrows 49, once the drain chute portion 24 has been folded to its closed condition" [0045]), and an access position, in which the deployable drain, in the retracted configuration is uncovered by the flap and is able to be accessed for deployment (after flap fastener 44 is released [0045]; FIG. 3);
wherein the fold line is located between the deployable drain in the retracted position and an uppermost edge of the ostomy pouch (see FIG. 2).
Murray fails to specify a foldable foam tab comprising an adhesive section adhered to an exterior surface of the outer wall, a fastening section comprising thereon a fastener disposed on an opposite surface of the foam tab to the adhesive section, and a tab fold line defining the adhesive section and fastening section; wherein the tab fold line is closer to a lower edge of the pouch than the flap fold line. However, Jones teaches improved methods to easily and reliably drain bodily waste from a reusable and drainable medical device such as an ostomy pouch ([0004]) comprising a foldable foam tab ("security flap 14" [0066]; “In some embodiments, the security flap comprises a memory foam-like material” [0069]; FIG. 5) comprising an adhesive section adhered to an exterior surface of the outer wall ("first portion 15 attached to one of the opposing walls of the medical device or pouch" [0066]), a fastening section ("freely extended portion 16" [0066]; FIG. 8) comprising thereon a fastener ("second fastener 17" [0067]; FIG. 8) disposed on an opposite surface of the foam tab to the adhesive section (see FIG. 8), and a tab fold line defining the adhesive section and fastening section (see FIG. 8).
Murray/Jones fails to specify the flap disposed over the foldable foam tab wherein the tab fold line is closer to a lower edge of the pouch than the flap fold line. However, the court has held that a rearrangement of parts is an obvious matter of design choice. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Therefore, it would have been obvious to locate the flap over the foldable foam tab wherein the tab fold line is closer to a lower edge of the pouch than the flap fold line since Murray discloses that the flap is for “substantially concealing, discretely, the rolled-up drain chute coil” ([0043]) and thus “enhances the visual effect of a closed pouch, with a substantially smooth and uninterrupted face or surface region, especially near the lower extremity of the pouch 10” ([0048]).
Regarding Claim 2, Murray discloses the at least one sheet of comfort material is attached to the outer wall at least about at least part of the periphery thereof ("comfort layer 30 may be an additional panel outside the front wall 12 and/or rear wall 14, and secured to the pouch 10 at, for example the peripheral seam 16" [0048]).
Regarding Claim 3, Murray discloses the fold line is defined by a line extending between two points about the periphery where the attachment between the at least one sheet of comfort material and the outer wall terminates (see FIGs. 1-2).
Regarding Claim 4, Murray discloses the flap is shaped such that an edge distal from the fold line conforms to the shape of the periphery of the ostomy pouch (see FIG. 1).
Regarding Claim 6, Murray discloses a fastener arrangement configured to retain the deployable drain in the retracted position ("fastener for fastening the drain chute portion 24 in a rolled-up closed configuration" [0039]; FIG. 4), the fastener arrangement comprising a first fastener located on an exterior surface of the deployable drain ("fastener part" 38 [0039]; FIG. 2) but fails to specify the fastener arrangement configured to engage the fastener of the foam tab. However, Jones teaches the fastener arrangement configured to engage the fastener of the foam tab ([0067]; FIG. 8). Therefore, it would be obvious to modify Murray to incorporate the claimed features as taught by Jones to suitably secure “the opening in the closed condition” ([0066]).
Regarding Claim 8, Murray fails to teach the tab fold line is the fold line about which the foldable foam tab is configured to fold between a fastened configuration and an un-fastened configuration. However, Jones teaches the tab fold line is the fold line about which the foldable foam tab is configured to fold between a fastened configuration and an un-fastened configuration ([0066-0067]). Therefore, it would be obvious to modify Murray to incorporate the claimed features as taught by Jones to suitably secure “the opening in the closed condition” ([0066]).
Regarding Claim 9, Murray/Jones fails to specify the foldable foam tab is exposed when the flap is in the access position. However, the court has held that a rearrangement of parts is an obvious matter of design choice. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Therefore, it would have been obvious modify Murray/Jones to incorporate the claimed features since Murray discloses that the flap is for “substantially concealing, discretely, the rolled-up drain chute coil” ([0043]) and thus “enhances the visual effect of a closed pouch, with a substantially smooth and uninterrupted face or surface region, especially near the lower extremity of the pouch 10” ([0048]).
Regarding Claim 11, Murray discloses the fold line of the flap is arranged between the tab fold line and the uppermost edge of the pouch (see FIG. 2).
Regarding Claims 12, 14-16, and 18, Murray fails to specify the tab fold line is arranged at least 0.5mm below the fold line of the flap; the tab fold line is arranged no more than 10mm below the fold line of the flap; the tab fold line is arranged no more than 5mm below the fold line of the flap; the fold line of the flap is arranged at a distance of between 20mm and 50mm from a lower edge of the pouch when the drain is in the retracted position; and the fold line of the flap is arranged at a distance of at least 1mm above the upper edge of the retracted drain. However, the instant specifications fail to provide any criticality for the claimed arrangements. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Murray to have the claimed fold line arrangements since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Murray would not operate differently with the claimed fold line arrangements and would have functioned appropriately as intended.
Regarding Claim 19, Murray discloses the flap is configured to fold around the fold line such that to move to the access position the end of the flap distal from the fold line is lifted away from the pouch and towards the uppermost edge of the pouch (see FIG. 2).
Regarding Claim 22, Murray discloses a method of forming an ostomy pouch ("ostomy pouch 10" [0028]), the method comprising:
providing an inner wall and an outer wall which define a cavity for containing stomal output ("front wall 12 and a rear wall 14" [0028]; FIG. 2), and a deployable drain for draining stomal output from the cavity ("outlet 22 in the form of a drain chute portion 24 of the pouch 10" [0031]);
wherein the deployable drain is moveable between an extended configuration for draining the stomal output from the cavity (FIG. 2) and a retracted configuration for storage of the deployable drain ("drain chute portion 24 is folded upwardly four times to its closed configuration" [0041]);
attaching a first sheet of woven comfort material ("comfort layer 30 is typically made of a soft cushioning material. A typical material includes a woven" [0048]) to the outer wall ("comfort layer 30 may be an additional panel outside the front wall 12 and/or rear wall 14, and secured to the pouch 10" [0048]), leaving a flap ("comfort layer 30 on the flaps 41, 42 is an extension of the comfort layer 30 on the respective pouch wall 12, 14" [0048]; FIG. 2) arranged to cover the deployable drain when in the retracted position ("flap fastener 44 is fastened by pressing the flaps 41, 42 together, as illustrated by arrows 49, once the drain chute portion 24 has been folded to its closed condition" [0045]; FIG. 3), the flap configured to fold along a fold line ("attached at points 54, 56" [0049]; FIG. 2);
wherein the fold line is located between the deployable drain in the retracted configuration and an uppermost edge of the ostomy pouch (see FIG. 2).
Murray fails to specify adhering an adhesive section of a foldable foam tab to an exterior surface of the outer wall, the adhesive section and a fastening section of the foldable foam tab being defined by a tab fold line about which the foldable foam tab is configured to fold between a fastened configuration and an un-fastened configuration; a flap arranged to cover the foldable foam tab and the deployable drain when in the retracted position; wherein a fastener is disposed on an opposite surface of the foam tab to the adhesive section, and wherein the tab fold line is closer to a lower edge of the pouch than the flap fold line. However, Jones teaches adhering an adhesive section of a foldable foam tab to an exterior surface of the outer wall ("first portion 15 attached to one of the opposing walls of the medical device or pouch" [0066]), the adhesive section and a fastening section of the foldable foam tab being defined by a tab fold line about which the foldable foam tab is configured to fold between a fastened configuration and an un-fastened configuration (“freely extended portion 16 of security flap 14 is configured to be folded over the outlet 7 when the outlet is in the closed condition” [0066]); wherein a fastener is disposed on an opposite surface of the foam tab to the adhesive section ("second fastener 17" [0067]; FIG. 8). Murray/Jones fails to specify a flap arranged to cover the foldable foam tab and the deployable drain when in the retracted position; wherein the tab fold line is closer to a lower edge of the pouch than the flap fold line. However, the court has held that a rearrangement of parts is an obvious matter of design choice. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Therefore, it would have been obvious modify Murray/Jone with the claimed arrangements since Murray discloses that the flap is for “substantially concealing, discretely, the rolled-up drain chute coil” ([0043]) and thus “enhances the visual effect of a closed pouch, with a substantially smooth and uninterrupted face or surface region, especially near the lower extremity of the pouch 10” ([0048]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray/Jones in view of Smith et al. (US 20110238024 A1).
Regarding Claim 5, Murray/Jones discloses the comfort material forming the flap but fails to specify the flap is coated with a hot melt adhesive. However, Smith teaches a drainage bag assembly for receiving bodily waste (see Abstract) wherein the flap is coated with a hot melt adhesive ("peelable non-repositionable adhesive is a hot melt adhesive" [0047]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Murray/Jones to incorporate the teachings of Smith to suitably provide a “peelable non-repositionable” zone ([0016]).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray/Jones in view of Mahood et al. (US 20230081026 A1).
Regarding Claims 20-21, Murray fails to specify the pouch further comprises a window opening for viewing the cavity; wherein the window opening is arranged on the outer wall, the at least one sheet of comfort material comprising a first and second part, wherein the first part partially overlaps the second part, or the second part overlaps the first part in an overlap region to form the window. However, Mahood teaches an ostomy pouch or wound bag ([0012]) comprising a window opening for viewing the cavity ("viewing window 37" [0062]; FIG. 2); wherein the window opening is arranged on the outer wall ([0062]; FIG. 2), the first sheet of comfort material comprising a first and second part, wherein the first part partially overlaps the second part, or the second part overlaps the first part in an overlap region to form the window ("flap 48 extends downwardly past the upper edge 34 of the lower panel and overlaps the lower panel 28 to obscure the viewing window 37" [0063]; FIG. 2). Therefore, it would have been obvious to incorporate the teachings of Mahood to allow a caregiver “to check the condition of the stoma or to observe stoma output” ([0006]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/ Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights