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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6 January 2026 has been entered.
Status of Claims
As directed by the amendment filed on 6 January 2026: claim(s) 1 have been amended, claim 3 has been canceled. Claims 1, 2, 4-16, and 18-21 are presently pending.
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 reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1-2, 4-14, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Villefrance et al. in view of Pontifex (US 4296749 A).
Regarding Claim 1, Villefrance discloses an ostomy appliance ([0029]; FIG. 1) including:
first and second walls connected to each other at or near their peripheries ("body side or proximal film 1, an opposed or distal film 2"; [0030]; FIG. 5);
a stoma-receiving opening for receipt of a stoma ("stoma-receiving apertures 8a"; [0034]; FIG. 1);
a collecting cavity defined between the first and second walls ("flatus gas chamber 3a and a faeces chamber 3b"; [0030]; FIG. 5) wherein the stoma-receiving opening is fluidly connected to the collecting cavity ([0034]; FIG. 1);
a connection member ("face plate 8"; [0033]; FIG. 1) connected to the first and/or second wall for attaching the appliance to a user or for attaching the appliance to a flange for attaching the appliance to a user ([0033]-[0034]; FIG. 1);
an outlet ("drainage opening or outlet 5"; [0031]; FIG. 1) which extends away from the stoma-receiving opening ([0031]; FIG. 1), the outlet including an outlet wall and terminating in an opening ([0031]; FIG. 4); and
a user graspable member ("gripping tabs 15 and 16"; [0051]; FIG. 4) for assisting in moving the outlet opening from a first, closed, condition to a second, open, condition ("tabs 15 and 16 can be used for pulling the strips 6 and 7 apart"; [0051]; FIG. 5);
wherein the user graspable member includes a graspable portion and an attachment portion (see FIG. 4);
wherein the attachment portion is attached to the outlet wall ("tabs 15 and 16 may both be attached to the strips 6 and 7, respectively, or to films 1 and 2"; [0051]; FIG. 4).
Villefrance fails to explicitly disclose the attachment portion being positioned closer to the stoma-receiving opening than the graspable portion wherein the attachment portion is positioned above the graspable portion. However, Pontifex teaches a colostomy appliance comprising a pouch 30 (see FIG. 1), an attachment portion, and a graspable portion (see pair of flexible pull tabs 42, 44 in FIG. 2) wherein the attachment portion being positioned closer to the stoma-receiving opening than the graspable portion (see FIGs. 1-2), and wherein the attachment portion is positioned above the graspable portion (see FIGs. 1-2). 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 Villefrance to incorporate the teachings of Pontifex to allow for grasping and pulling “away from one another to separate the flexible panels” (col. 3 ln. 9).
Regarding Claim 2, Villefrance discloses the user graspable member is positioned at or near the outlet opening (see FIG. 4).
Regarding Claims 4-7, Villefrance discloses the graspable portion and the graspable portion is attached to the attachment portion by a connection portion (see FIG. 4) but fails to specify the graspable portion is movable, e.g. pivotally movable, relative to the attachment portion; the graspable portion has a free end remote from the attachment portion which is moveable by the user away from the outlet wall; the graspable portion is pivotable about the connection portion; and the connection portion defines an axis A about which the graspable portion pivots.
However, Villefrance discloses an analogous flap 10 of flexible film material attached to film 1 by welding or glueing an edge portion 11 of flap 10 to film 2 ([0036]; FIG. 3) comprising a gripping tab 13 for being gripped by the user's fingers ([0037]; FIGs. 3-4) that is movable, e.g. pivotally movable, relative to the attachment portion 11 ([0037]; FIGs. 3-4); has a free end 13 remote from the attachment portion 11 which is moveable by the user away from the outlet wall 2 ([0037]; FIGs. 3-4); is pivotable about the connection portion ([0037]; FIGs. 3-4); the connection portion defines an axis A about which the graspable portion pivots (“rotated in the direction R1 compared to the position of flap 10 shown in FIGS. 2 and 3 where the flap 10 abuts the film 2, i.e. being rotated as far as possible in the direction R2”; [0037]; FIGs. 3-4). 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 Villefrance to incorporate the features of the analogous flap 10 on the graspable portion to improve the ease of use ([0002]-[0010]).
Regarding Claim 8, Villefrance discloses the outlet is foldable between an extended position ("coil can be unrolled"; [0044]) and a stowed position ("closed coiled position"; [0042]);
wherein the attachment portion and graspable portion lie in generally the same plane in the stowed position (see FIG. 4).
Regarding Claim 9, Villefrance discloses a stiffening member attached to or forming part of the outlet wall and positioned at or near the outlet opening ("proximal stiffening strip 6 and a distal stiffening strip 7"; [0032]; FIG. 4).
Regarding Claim 10, Villefrance discloses the stiffening member includes a first edge and a second edge (see Annotated FIG. 4), where the stiffening member second edge is positioned closer to the stoma-receiving opening than the stiffening member first edge (see Annotated FIG. 4), and wherein a height Hs of the stiffening member is defined between the first and second stiffening member edges (see Annotated FIG. 4); and
wherein a periphery of the user graspable member includes a first edge and a second edge (see Annotated FIG. 4), where the user graspable member second edge is positioned closer to the stoma-receiving opening than the user graspable member first edge (see Annotated FIG. 4), and wherein a height Ht of the user graspable member is defined between the first and second user graspable member edges (see Annotated FIG. 4);
wherein the height Ht is less than the height Hs (see FIG. 4).
Annotated FIG. 4
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Regarding Claim 11, Villefrance discloses the user graspable member lies entirely within a periphery of the stiffening member (see FIG. 4).
Regarding Claim 12, Villefrance discloses a security flap ("flap 10"; [0036]; FIG. 1) to secure the outlet in a stowed position ("rotating the flap 10 in the direction R1 until the two Velcro strips 9 and 12 abut and engage each other for locking said coil in the final closed and secured position of the discharge portion"; [0041]).
Regarding Claim 13, Villefrance discloses the graspable portion includes a formation for receipt of the user's finger to permit the user to grasp the user graspable member (see FIG. 4).
Regarding Claim 14, Villefrance discloses the formation forms part of a periphery of the user graspable member (see FIG. 4).
Regarding Claim 21, Villefrance discloses the outlet wall is a continuation of or connected to one of the first or second walls which define the collecting cavity (see FIGs. 3-5).
Claim(s) 15-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Villefrance/Pontifex in view of March et al. (US 20120130329 A1).
Regarding Claims 15-16 and 18-20, Villefrance/Pontifex discloses the user graspable member and the formation but fails to specify the formation is a recess of the periphery; the recess is curved or arcuate; or wherein the recess extends towards the attachment portion; the formation provides a different tactile or visual characteristic to a remainder of the graspable portion to indicate to the user which portion of the user graspable member to grasp; the user graspable member is formed of a synthetic material; and the user graspable member is formed of polyester.
However, March teaches a user graspable rotatable member (“grasping region 68”; [0050]; FIG. 10A) comprising a formation 86 ([0053]; FIG. 10B) wherein the formation is a recess of the periphery (“recessed area 86 within the bounding wall 72”; [0053]; FIG. 10A); the recess is curved or arcuate; or wherein the recess extends towards the attachment portion (“recessed area 86 within the bounding wall 72”; [0053]; FIG. 10A); the formation provides a different tactile or visual characteristic to a remainder of the graspable portion to indicate to the user which portion of the user graspable member to grasp (“higher friction tactile element 74 is positioned within the recessed area 86 in the grasping region 68”; [0054]); the user graspable member is formed of a synthetic material (“higher friction tactile element 74 may be formed from a thermoplastic elastomer (TPE)”; [0055]); and the user graspable member is formed of polyester (“higher friction tactile element 74 may be formed from a thermoplastic elastomer (TPE)”; [0055]; NOTE: thermoplastic elastomer (TPE) is a type of polyester). Therefore, it would have been obvious to modify the device of Villefrance/Pontifex to incorporate the teachings of March to suitably provide “a no-slip or lesser slip surface than the frame portion 70 for a more positive hold” ([0049]) and “positive tactile indication” ([0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
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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Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781