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 13 May 2026: claim(s) 1 have been amended, claim 12 has been canceled. Claims 1, 2, 4-11, 13-16, and 18-21 are presently pending.
Response to Arguments
Applicant's arguments filed 13 May 2026 have been fully considered but they are not persuasive.
Regarding the argument that “a person of ordinary skill in the art when looking at how to improve the Villefrance device would find no motivation whatsoever to modify the drainage portion and ancillary components of the drainage portion of the Villefrance device. This is because doing so would go completely against the teachings of Villefrance, which is something a person of ordinary skill in the art would plainly not do”, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Pontifex teaches the “pair of flexible pull tabs 42, 44 respectively are adhered to the outer surface of panels 32, 34 respectively” and “may be grasped and pulled away from one another to separate the flexible panels 32, 34”. Furthermore, the court has held that rearranging the position of a disclosed element would be obvious. MPEP 2144.04(VI)(C). Therefore, it would be obvious to modify Villefrance’s relative arrangement of the attachment portion and the graspable portion as taught by Pontifex to better pull apart the surfaces to which the pull tabs are attached to. The relative arrangements of the attachment portion and the graspable portion disclosed by Villefrance does not explicitly exclude the relative arrangement taught by Pontifex, and vice versa. Thus, Villefrance and Pontifex do not teach away from each other nor from the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 21 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 21’s limitation “the outlet wall is a continuation of or connected to at least one of the first or second walls which define the collecting cavity” is already recited in independent Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 4-11, 13-14, 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);
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]); 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 outlet wall is a continuation of or connected to at least one of the first or second walls which define the collecting cavity ("elongate drainage portion ending in a drainage opening or outlet 5 defined by the lower ends of films 1 and 2 extends downwards from the main portion of the pouch" [0031]; FIGs. 1-3);
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
PNG
media_image1.png
539
514
media_image1.png
Greyscale
Regarding Claim 11, Villefrance discloses the user graspable member lies entirely within a periphery of the stiffening member (see FIG. 4).
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 ("elongate drainage portion ending in a drainage opening or outlet 5 defined by the lower ends of films 1 and 2 extends downwards from the main portion of the pouch" [0031]; FIGs. 1-3).
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
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781
Prosecution Insights