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 .
Claim Rejections - 35 USC § 112
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.
Claims 5 and 15 are 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “a spiky shape”, and the claim also recites “more preferably … a cone shape” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Allowable Subject Matter
Claims 1-4, 6-14, and 16-18 are allowed.
Claims 5 and 15 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose the claimed invention, a stoma plug comprising a tube, a two-way valve system, and a cap, wherein the two-way valve system comprises a base element and a plug, and either an actuator wherein the valve is configured to passively remain closed such that when the actuator is not actuated the plug covers the base element and the actuator displaces the plug to unseal an opening in the plug and reseal the opening when the actuator stops being actuated, or a spring a plug stopper. The closest prior art, made herein of record but not relied upon for any rejection is:
U.S. Patent 4,804,375 to Robertson discloses a valve for a stoma plug, as shown in figure 17, but the valve is closed by twisting a flexible tubing member, not by sealing and unsealing an opening in a base element with a plug.
U.S. Patents 6,723,079 to Cline, 7,001,367 to Arkinstall, 10,813,787 to Dinakara et al. disclose valves for stoma plugs, but the valves are one-way valves, not two-way valves.
U.S. Patent 11,065,145 to Alvarez Ponce discloses a valve for stoma plug, but the valve is an electromagnetic valve that closes by collapsing the intestinal lumen, not by sealing and unsealing an opening in a base element with a plug.
The prior art of record therefore does not disclose nor fairly suggest the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patents 4,804,375; 7,001,367; 6,723,079; 10,813,787; and 11,065,145 disclose stoma devices comprising valves.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNNE ANDERSON whose telephone number is (571)272-4932. The examiner can normally be reached Monday-Friday 10-6.
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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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/CATHARINE L ANDERSON/Primary Examiner, Art Unit 3781
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