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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-25) without traverse of claims in the reply filed on 4/24/26 is acknowledged.
Claim Rejections - 35 USC § 112
3. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
4. Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
5. Claim 8 recites the limitation "peritoneum". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claim(s) 1-4, 8-13, 22-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arkinstall 7,001,367.
Arkinstall discloses the invention as claimed noting for example fig. 4 comprising a prosthetic sphincter apparatus (this is the ostomy drain device 10) comprising: a valve (46) controllable between an open position for allowing waste to pass through the valve and a closed position for preventing waste from passing through the valve; and an implant (conduit 12) configured to be surgically attached to a body part and to lock the valve inside the implant, wherein the valve is configured to be controllable between the open position and the closed position while remaining locked inside the implant (The italicized represents functional language. See MPEP 2114 which states:
II. MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).
8. Regarding claim 2, “wherein the valve and the implant are configured such that the valve can be repeatedly removed from and reinserted into the implant” is intended use functional language (see MPEP 2114).
9. Regarding claim 3 the proximal and distal openings of the conduit (12) are considered to holes.
10. Regarding claim 4, “…wherein the implant comprises a flange protruding radially outwards for anchoring the implant” see (26 and 38) of Arkinstall.
11. Regarding claim 8 see element 40.
12. Regarding claims 9-13 the recitations recite functional language e.g. “…arranged such that twisting of one end of the flexible tube relative to the other end of the flexible tube causes the valve to be controlled between the open position I which the channel s open and the closed position…”. See MPEP 2114 supra. (It is suggested that applicant recite the actual structure that causes the function to happen).
13 Regarding claims 14, 16 see movable components (46).
14. Regarding claims 23-24, see fig. 4.
15. Claim(s) 1 and 19, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alvarez Ponce 2018/0360644 (hereafter Ponce).
Ponce discloses a prosthetic sphincter apparatus (see fig. 1) comprising: a valve (30) controllable between an open position for allowing waste to pass through the valve and a closed position for preventing waste from passing through the valve; and an implant (conduit 10) configured to be surgically attached to a body part and to lock the valve inside the implant, wherein the valve is configured to be controllable between the open position and the closed position while remaining locked inside the implant (The italicized represents functional language. Ponce further discloses an actuator for controlling an open and closed position (see element 50 and [0029]).
Claim Rejections - 35 USC § 103
16. 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.
17. Claim(s) 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Arkinstall 7,001,367 in view of Brönnimann 10,265,211 (hereafter ‘211). Arkinstall has been disclosed supra however does not specify that the flange comprises a mesh or that the implant comprises hooks. Bronnimann teaches an ostomy implant which comprise a flange made of mesh and teaches that the implant may be secured with one or more hooks. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Arkinstall and utilize a mesh flange with hooks in order to further aid in anchoring the device to the surrounding tissue.
Claim Rejections - 35 USC § 103
18. 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.
19. Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Arkinstall 7,001,367. Arkinstall has been disclosed however does not specify that the implant comes in to separate pieces. It would have been obvious to one having ordinary skill in the art to modify the invention of Arkinstal and provide separate pieces of the implant for assembly (see as evidenced by Holmberg et al. 2003/0139805 [0108]) in order to give the surgeon control during the implantation process.
Allowable Subject Matter
20. Claims 15, 17-18, 20-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 June 8, 2026
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